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How to run BPR processes with R4BP 3 in Member State
competent authorities Release date: October 2016
1
Biocides
How to run BPR processes with R4BP 3 in Member State competent authorities
MANUAL for authority users
Biocides
How to run BPR processes with R4BP 3 in Member State competent authorities
MANUAL for authority users
2
How to run BPR processes with R4BP 3 in Member State competent authorities
Reference: ECHA-16-B-33-EN
Cat number: ED-01-16-966-EN-N
ISBN: 978-92-9495-632-3
DOI: 10.2823/745232
Publ. date: October 2016
Language: EN
© European Chemicals Agency, 2016
Cover page © European Chemicals Agency
Legal notice:
Neither the European Chemicals Agency nor any person acting on behalf of the European
Chemicals Agency is responsible for the use which might be made of the following information.
A wealth of additional information on the European Chemicals Agency is available on the
Internet. It can be accessed through the ECHA website (http://echa.europa.eu).
Reproduction is authorised provided the source is fully acknowledged in the form
“Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written notification
is given to the ECHA Communications Unit ([email protected]).
If you have questions or comments in relation to this document please send them (quote the
reference and issue date) using the information request form. The information request form is
accessible from the Contact ECHA page at: http://echa.europa.eu/contact
European Chemicals Agency
Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland
How to run BPR processes with R4BP 3 in Member State
competent authorities Release date: October 2016
3
Version Changes Date
Version 1.0 First version. August 2013
Version 2.0
Version 3.0 Version 4.0
Version 5.0
Version 6.0
The manual is updated to incorporate the changes implemented in R4BP 3.1. Six new processes are added, new steps described and streamlined in the process sections, workflow are inserted in the process sections to visualise each single process. New enhanced case event history page has been added. Management of asset document functionality has been added.
The manual is updated to incorporate the changes implemented in R4BP 3.1.2. Four new processes are added: provisional authorisations, renewal of mutual recognition, and new active substance under BPD. The manual is updated to incorporate the changes implemented
in R4BP 3.2. As many as 23 new processes are added. The sequence of the sections has been aligned with that of the industry submission manuals. To avoid repetitions the explanation of the legal framework of each case type (processes) has been referred to the relevant chapters of the BPR practical guide. In the same way the description of the applications
requirements is delegated, when relevant, to the respective submission manuals via dedicated links. To further reduce the length of the document the workflows’ charts have been summarised in one table and are not anymore displayed at the beginning of each section. The manual is updated to describes how the ad hoc
communication supports .xml files and the new communication channels for review programme-related case types work. The SPC sections (3.8.1 to 3.8.3) have also been improved. The
template for the rejection of an application has been repealed since R4BP 3 manages the process automatically. Three new case types have been added: Approval of an active substance in an additional product type, National authorisation cancellation on request and Union authorisation major change on request. Information about meta SPC concept and migration of SPCs from old to new format has been added in the SPC section (3.8.2 and 3.8.3). The CA supporting documents for CA and SPC agreement have been added as Annex I and II in this manual.
April 2014
June 2014 December 2014
February 2016
October 2016
4
Table of Contents
1. Introduction ........................................................................................................... 7
2. What is R4BP 3? ................................................................................................... 13
Working in R4BP 3 ................................................................................................ 14
AS-APP Active substance approval ....................................................................... 47
AS-EVA Active substance evaluation under Directive 98/8/EC ............................. 48
AS-NAS New active substance evaluation under Directive 98/8/EC ..................... 50
AS-RNL Renewal of the approval of an active substance ..................................... 50
AS-NPT Approval of an active substance in an additional product type ................ 51
AN-APP (1-5) Amendment of Annex I .................................................................. 51
AN-APP (6) Amendment of Annex I .................................................................... 53
NA-APP National authorisation ........................................................................... 53
NA-APP (WA) Provisional national authorisation Article 55(2) ........................... 55
NA-RNL Renewal of National authorisation ........................................................ 58
NA-RNL Renewal of National authorisation subject to mutual recognition ......... 59
NA-MRP Mutual recognition in parallel ............................................................... 64
NA-MRS Mutual recognition in sequence ............................................................ 67
NA-BBP, NA-BBS National authorisation of the same biocidal product ............... 70
NA-ADC National authorisation - Administrative change on request ................... 73
NA-TRS Transfer of a national authorisation ...................................................... 74
NA-MRG Merge of product authorisations in one product family ......................... 75
NA-MIC National authorisation - Minor change on request ................................. 76
NA-MAC National authorisation - Major change on request ................................ 79
NA-AAT Amendment of National authorisation ................................................... 82
NA-CAT Cancellation of national authorisation ................................................... 84
NA-CCL National authorisation cancellation on request ...................................... 85
ET-NOT Notification for experiment or test ......................................................... 85
NA-NPF Notification of product in product family for national authorisation ...... 86
Settlement of disagreements (n/a) .................................................................... 87
NE-NOT Notification of an unexpected or adverse effect national authorisation . 88
PP-APP Parallel Trade ......................................................................................... 88
PP-AAT Amendment of parallel trade permit ...................................................... 89
PP-CAT Cancellation of parallel trade permit ...................................................... 90
SA-APP National authorisation – simplified procedure ....................................... 90
How to run BPR processes with R4BP 3 in Member State
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SA-BBS Simplified authorisation of the same biocidal product (authorised) ....... 91
SA-BBP Simplified authorisation of the same biocidal product (pending) ........... 92
SA-CAT Cancellation of simplified authorisation ................................................. 92
SA-AAT Amendment of simplified authorisation ................................................. 93
SA-ADC Simplified authorisation administrative change on request ................... 94
SA-TRS Transfer of a simplified authorisation .................................................... 95
SA-MIC Simplified authorisation minor change on request ................................. 95
SA-MAC Simplified authorisation major change on request ................................ 96
SA-NPF Notification of product in product family for simplified authorisation .... 97
SE-NOT Notification of unexpected or adverse effect for SA ............................... 97
SN-NOT Notification for placing on the market - simplified procedure ................ 98
UA-APP Union authorisation ............................................................................... 99
UA-APP (WA) Provisional Union authorisation ................................................. 100
UA-MAC Union authorisation major change on request .................................... 102
Table of Figures Figure 1: R4BP 3 homepage ..................................................................................................... 14
Figure 2: Searching for a task .................................................................................................. 16
Figure 3: ‘Tasks list’ ................................................................................................................. 17
Figure 4: Searching for a message ........................................................................................... 17
Figure 5: Searching for a case ................................................................................................. 19
Figure 6: ‘Case list’ .................................................................................................................. 20
Figure 7: “Case details page” ................................................................................................... 22
Figure 8: Case inventory history page...................................................................................... 23
Figure 9: Searching for an asset .............................................................................................. 23
Figure 10: ‘Assets list’ ............................................................................................................. 24
Figure 11: ‘Asset details’ page ................................................................................................. 24
Figure 12: ‘TASKS’ page ........................................................................................................... 26
Figure 13: ‘MSCA accept’ page ................................................................................................. 26
Figure 14: ‘MSCA accept’ page, release the task function. ....................................................... 27
Figure 15: ‘MSCA accept’ page 1/2 .......................................................................................... 28
Figure 16: ‘MSCA accept’ page 2/2 .......................................................................................... 29
Figure 17: ‘Complete task confirmation’ page .......................................................................... 29
Figure 18: ‘Validate’ page of the “Validate” task. .................................................................... 30
Figure 19: ‘Evaluate’ page of the “Evaluate” task. ................................................................... 30
Figure 20:‘Evaluate & Decide’ page of the “Evaluate & Decide” task. ...................................... 31
Figure 21: Management of SPC files......................................................................................... 31
Figure 22: Management of asset document. ............................................................................ 33
Figure 23: ‘Provide your decision page’1/2 ............................................................................. 37
6
Figure 24: ‘Provide your decision page’2/2 ............................................................................. 38
Figure 25: Select the Topic’ page ............................................................................................. 39
Figure 26: Case details – Financial management tab’ page ...................................................... 41
Figure 27: ‘Financial information’ page .................................................................................... 41
Figure 28: ‘Upload new invoice’ page ...................................................................................... 42
Figure 29: ‘Upload new invoice’ page, select language ............................................................ 42
Figure 30: ‘Financial information - send’ page ......................................................................... 42
Figure 31: ‘Confirmation message’ page .................................................................................. 43
Figure 32: ‘Financial information – handle invoices – Fee paid’ page ...................................... 43
Figure 33: ‘Financial information – handle invoices – unpaid’ page ......................................... 44
Figure 34: Tracking the reference case or asset of a same biocidal product ............................ 72
Table of Tables Table 1: Example of process flow chart.................................................................................... 11
Table 2: Case type and SPC correlation table ........................................................................... 34
How to run BPR processes with R4BP 3 in Member State
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1. Introduction
1.1. Objective
This manual addresses users working in the competent authorities of the Member States of
the European Union as well as of Iceland, Norway, Liechtenstein and Switzerland where
appropriate.
The purpose of this manual is to describe the key steps authority users need to perform under
the Biocidal Products Regulation (BPR). It describes the main steps in the IT-tool “Register
for Biocidal Products (R4BP 3)”, to communicate and exchange information with other Member
State competent authorities, the European Chemicals Agency (ECHA) or the Commission.
This manual focusses on the submission and evaluation process of applications and
submissions under the BPR. It will progressively be adapted to cover all the processes
foreseen by the BPR.
1.2. Conventions and terminology
The following text conventions are used throughout this manual:
AS Active substance
MR renewals
Regulation Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014
supplementing Regulation (EU) No 528/2012 of the European
Parliament and of the Council as regards the rules for the renewal of
authorisations of biocidal products subject to mutual recognition
BP Biocidal product
BPC Biocidal Products Committee
BPR Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market
and use of biocidal products
CAR Competent authority report (for active substance)
cMS Concerned Member State
eCA Evaluating (Member State) competent authority
ECHA European Chemicals Agency
IUCLID International Uniform Chemical Information Database
I6z File format of IUCLID files
MSCA Member State competent authority
8
PAR Product assessment report
R4BP 3 Register for Biocidal Products, version 3, established and maintained
by ECHA
rMS Reference Member State (for the process national authorisation
receiving Member State)
PT Product-type
SPC Summary of biocidal product characteristics
UUID
BRC
EAA
MSCA
initiated
Unique Universal Identifier (it can be related to Company, Dossier)
Business Rules Confirmation
ECHA Accept
MSCA initiated
MAA
VAL
MEV
EVL
OPN
MSCA Accept
Validate
MSCA Evaluate
Evaluate and decide
ECHA Opinion
DEC COM Decision
WA Work around. Another case type is used to cover the process. A
supporting document helps to identify the correct process.
The following icons are used throughout this manual:
Useful information, guidance, assistance
Very important note
How to run BPR processes with R4BP 3 in Member State
competent authorities Release date: October 2016
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1.3. Definitions and concepts
Applicant A legal entity in whose name an application is submitted under
the BPR, e.g. an entity applying for the approval of an active
substance (AS) or a prospective authorisation holder.
Application The formal request to an authority made by the applicant and
evaluated by an authority.
Asset In the R4BP 3 context, an asset is a regulatory decision on an
application (with a unique asset number) related to either an
AS (e.g. a decision on technical equivalence or a decision on
the compliance with Article 95) or a biocidal product (BP) (e.g.
a national authorisation or a Union authorisation), or a
notification (e.g. notification of experiment or test or inquiry).
Asset owner The legal entity in whose name an application or notification is
made under the BPR (e.g. the applicant for product
authorisation, parallel trade permit, decision on technical
equivalence).
Authorisation holder The person established within the Union who is responsible for
the placing on the market of a BP in a particular Member State
or in the Union, and specified in the regulatory decision.
Authority users The authority users are comprised of ECHA, the Member State
competent authorities (MSCA) and the Commission.
Case In R4BP 3, a case relates to an application or notification
submitted by an industry user that follows a series of tasks to
complete a pre-defined workflow. A unique case number
identifies a case in R4BP 3. It includes all the steps in the
application process, which lead to the creation, or the update,
of an asset (the regulatory decision). The case number helps
to manage and view the progress of a submission by both
industry and authority users.
Case owner The legal entity which creates the case and is following it
through its processing, paying any invoices, providing any
additional information requested by authorities, commenting
on any draft evaluation reports or opinions, etc. The case
owner is either the asset owner or the representative of the
asset owner acting on behalf of the asset owner.
Event An event is a step whereby information is submitted that is
needed in the handling / processing of an application.
Examples include the submission of an application, the
submission of additional information on the request of the
authorities, fee payment, and the communication of a
decision.
Industry user The legal entity user registered in R4BP 3.
IVA cycle IVA is the acronym for Initiation, Verification and Authorisation
users. An IVA cycle is a quality tool using the two to three pair
of eyes principle. The first person initiates a task, a second
10
person verifies the correctness of the task and the third person
authorises the execution of the task. For MSCAs currently only
the I cycle is implemented in R4BP 3.
Task A working item created by R4BP 3 and assigned to a specific
user group (industry or authority users). A task is created in
order to complete certain actions (e.g. request for additional
information) that are required from the user. These requests
are completed through task items within a defined time period.
The task is identified by the task name and is related to a
particular case number.
1.4. Structure of the document
The structure of the document is as follows: sections 2 and 3 provide a general introduction
to the IT-tool R4BP 3 and its main functions, whereas sections 4 to 44 describe, using a
stepwise approach, the BPR processes relevant to Member States. An overview of all R4BP 3
processes in which MSCA are involved is given in the table of content at the beginning of this
manual.
Each section related to a BPR process is divided in subsections:
1. The “Introduction” subsection provides a link to the relevant chapter(s) of the Practical
Guide where an explanation of the regulatory frame is given.
2. It is followed by the description of the “workflow” types (e.g. BRC > MAA > VAL > EVL).
The acronyms are explained in section 1.2. The dark blue colour highlights the tasks
under MSCA responsibility. They will be explained in details in each subsection “Steps
to be followed by MSCAs”.
3. The “Application requirements” subsection describes, sometimes also referring to the
industry submission manuals, what it is required in a case type (application or
notification) to enable the authority users to correctly receive it.
4. The subsection “Steps to be followed by MSCAs” explains (only) the tasks expected to
be performed by the authority users in a MSCA1. For information on the tasks
performed by the applicant please refer to the relevant industry submission manuals
webpage.
5. Eventually, the subsection “Supporting documents” lists templates (Annex I ans II to
this manual) provided by ECHA to facilitate the MSCA’s work. Please note that this
subsection is only present when supporting documents are required.
6. Table 1: summarises the case types codes, the workflow types and the related
workflow charts. The table of content of this manual explains the case type codes used
in the first column whereas the acronyms in column two are explained in section 1.2.
1 In this manual, authority users are users in an MSCA unless otherwise specified.
How to run BPR processes with R4BP 3 in Member State
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Table 1: Example of process flow chart
Case types Workflow types Workflow charts
NA-MRP NA-MRS
BRC > EAA > MAA > VAL > EVL
NA-APP NA-RNL NA-MIC NA-MAC NA-BBS NA-BBP SA-BBS SA-BBP
BRC > MAA > VAL > EVL
NA-ADC
NA-TRS NA-MRG
PP-APP SA-APP SA-MAC SA-MIC
BRC > MAA > EVL
NA-NPF ET-NOT SN-NOT SA-NPF SA-ADC SA-TRS SE-NOT
NE-NOT
NA-CCL
BRC > EVL
12
NA-AAT
NA-CAT
PP-AAT PP-CAT SA-AAT SA-CAT
MSCA initiated > EVL
AS-RNL AS-NAS UA-APP
AS-NPT
UA-MAC
BRC > EAA > VAL > MEV > OPN > DEC
AS-APP AS-EVA AN-APP (6)
SID > BRC > EAA > VAL > MEV > OPN > DEC
AN-APP (1-5)
SID > BRC > EAA > MAA > MEV > OPN > DEC
How to run BPR processes with R4BP 3 in Member State
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2. What is R4BP 3?
R4BP 3 is an information system established and maintained by ECHA with the aim of
ensuring that the BPR processes are managed by appropriate IT applications, to meet the
requirements set out in the BPR. R4BP 3 provides appropriate functions that allow the
exchange of information between industry and authority users (ECHA, MSCAs and
Commission). R4BP 3 shall be used to record and communicate the decisions on
authorisations taken in the MSCA and at Union level (see Article 71(6) of the BPR).
R4BP 3 consists of two main independent applications, one for all the authority users and
one for industry users.
2.1. Authority application
The R4BP 3 authority application enables authority users to support their day-to-day work
in the regulatory processes. With input from authority users, the system processes the
applications submitted by industry users and facilitates interaction between authority users.
The processes relevant to MSCA authority users are described in the following sections.
2.2. Industry application
The R4BP 3 industry application enables industry users to submit applications, notifications
and information for all processes under the BPR. R4BP 3 also provides the possibility of
monitoring applications, notifications, and asset portfolios. Through the industry interface,
industry users are able to log in, submit applications, review data, download documents
such as invoices, view the status of submitted applications and payments, and receive
notifications from the authorities and complete tasks assigned to them by authority users.
14
Working in R4BP 3
3.1 R4BP 3 homepage
After logging into the R4BP 3 portal, you are presented with the “Homepage” of R4BP 3. The
homepage contains the following features (Figure 1):
1. Clicking on the ECHA logo in the top left corner, directs you back to the homepage
from any other page. This feature is available on all of the R4BP 3 pages.
2. The taskbar at the top of the page next to the ECHA label contains four main tabs –
‘TASKS’, ‘MESSAGES’, ‘CASES’ and ‘ASSETS’. Each tab allows you to perform certain
actions or view information related to all of the applications submitted. This taskbar is
available in all of the R4BP 3 pages. More information on each of the tabs is provided
in the following sections of this section.
3. The ‘User ID’ is displayed at the top left corner below the ECHA label, as welcome,
<’user ID’>. This information is displayed in all of the R4BP 3 pages.
4. The log-out button ( button) is available at the top right corner. This feature is
available in all of the R4BP 3 pages.
5. A list of the oldest 10 tasks ‘claimed’ by the user is displayed sorted by submission
date.
6. A list of group tasks is displayed. The system shows 10 ‘All open tasks’ (claimed and
unclaimed), sorted by submission date (oldest on top). Group tasks are all tasks that
are sent to the MSCA, i.e. EVL (evaluation) task, and REC (reply communication) task.
7. Only the 10 latest messages are displayed. Red messages indicate that the message
has not been read yet. The messages are sorted in reversed chronological order by
the receiving date. New unread messages and messages that have been read are
displayed accordingly in the list.
8. Useful explanations can be found on the right hand side, in the yellow ‘Good to know’
box.
Figure 1: R4BP 3 homepage
How to run BPR processes with R4BP 3 in Member State
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3.2 Tasks
A task is a working item that is created automatically during the application process by
R4BP 3 or by an authority user when requesting further information. A task is characterised
by a unique task number and is assigned to a specific industry or authority user. A task is
created in order to complete certain actions that are required from the applicant or another
authority user.
Both tasks and messages are the starting point for an authority user to start working
in R4BP 3. Cases and assets are used for reference, i.e., to know more about the
terms and conditions of an authorisation, to know more about related cases or to
verify in the events history section the status of a case.
3.2.1 Search for tasks
When you select the ‘TASKS’ tab, a page is displayed with a searchable table containing all
of the tasks assigned to you.
You can search for a specific task by filling in some search criteria (Figure 2):
1. Filter task items by: “All open tasks (default)”, ‘Completed’, “ Overdue”, ‘My group(s)
claimed tasks’, ‘My group(s) unclaimed tasks’, ‘Claimed by me’.
2. Task name: e.g. ‘BRC confirmation, ‘MSCA accept’, ‘Evaluate & Decide’, ‘Reply to
communication’.
3. IVA steps: For further information please go to section 3.8.
4. ‘Due date’, ‘Submission date’, ‘Creation date’, ‘Completion date’ filters can be selected
here.
5. The “from” and “to” dates, linked to point 4 can be inserted here.
6. You can search here by ‘Task number’ (please insert only digits).
7. Case number: enter the unique ID of the case. The case number is created in R4BP 3 as
soon as an application is submitted.
8. Case types: the codes and a short description of each case types is given in the drop down
menu. A list of case types is provided in the table of content of this manual.
9. Product name: for applications related to biocidal products, enter the complete product
name.
10. Common name (AS): for IUCLID applications related to active substances, enter the
common name.
11. You can export the selected list of tasks in .xls format (excel) by clicking the “Export (.xls)”
button.
16
Figure 2: Searching for a task
When searching for a product name, you can type part of the name
and all the entries containing that letter(s) combination will be
displayed.
Search in R4BP 3 is not case sensitive.
No integrated “Back” button exists. A new search needs to be
performed in R4BP 3 if you select one task and intend to go back to
your initial search results.
3.2.2 The task list
The tasks are displayed in the ‘Tasks list’ (Figure 3) under the ‘TASKS’ tab and include the
following information:
1. Task name describing the task type (e.g.Validate application). The “I” stands for initiator
(you can also find “V” and “A” standing for validator and authoriser respectively). The task
name is a hyperlink to the corresponding task item. For further information please go to
section 3.8.
2. Case number is a hyperlink to the corresponding ‘Case details’ page (Figure 6).
3. Product name if provided in the dossier or in the SPC (when submitting a dossier is not
mandatory).
4. Active substance name.
5. Case type
6. Submission date of the case.
7. Due date.
8. Tasks can have the following statuses:
Unclaimed: all open tasks created and not yet claimed by a specific user.
Claimed: a task that is claimed by a specific user in order to perform the actions
of a task.
Completed: once the claimant of a task performs the task actions and completes
the task, its status changes to ‘Completed’. The task is considered closed; you can
view the task details, but cannot perform any further actions.
How to run BPR processes with R4BP 3 in Member State
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R4BP 3 provides in the task list a reminder feature through which “late”
and “soon to be late” tasks are highlighted. The task will not be auto-
completed even if the deadline is missed but it will appear as late in
the users’ task list.
Figure 3: ‘Tasks list’
3.3 Messages
R4BP 3 is the communication channel between authority and industry users (Article 71(6)
BPR). In particular, an authority user will use the messages tab to check the status of the
messages received and sent via R4BP 3. Information on how to send messages is given in
section 3.10 (ad hoc communication/ new communication). ECHA advises R4BP 3 users to
regularly check whether there are any new messages in their message inbox.
Note that the messages available in the ‘MESSAGES’ tab are in “read-only” format. You
cannot reply to a message from this tab. Please see section 3.10.
Any message sent by you as an authority user will be assigned a unique number, i.e. a
‘Communication number’ or a ‘Decision number’.
You can search for a specific message by filling in some search criteria like (Figure 4):
1. Sent/Received filter buttons.
2. Communication number.
3. Sender: e.g. “Industry”, “Agency” or “MSCA”.
4. Message status: ‘Read’ or ‘Unread’.
5. The received “from” and “to” dates.
Figure 4: Searching for a message
18
3.3.1 Message search results
The messages are displayed in the ‘Message list’ under the ‘Messages’ tab and include the
following information:
1. Sender or recipient .
2. Topic: Subject (this is hyperlinked to the communication details)
3. Product/Substance name.
4. Received or Sent Date.
3.4 Cases
A case identifies an application or notification upon successful submission of an application
or notification in R4BP 3. A series of steps need to be completed by authority users in the
application process leading up to the decision according to the BPR. The purpose of a case
is to manage and view the progress of the application and its evaluation.
3.4.1 Search for Cases
When you select the ‘Cases’ tab, a page is displayed with a searchable table containing all
of the cases assigned to you.
You can search for a specific case by filling in some search criteria (Figure 5a, 5b):
1. Case number: unique code create for each application.
2. Case types: the codes and a short description of each case types is given in the drop down
menu. A list of case types is provided in the table of content of this manual.
3. Case status: e.g. In Progress, closed.
4. Dossier UUID: enter the unique universal identifier of the IUCLID dossier (41 alpha-
How to run BPR processes with R4BP 3 in Member State
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numeric code).
5. Evaluating Authority Type: e.g. Agency or MSCA.
6. Evaluating Country (MSCA).
7. Company UUID: enter the unique universal identifier of the relevant company (41 alpha-
numeric entries).
8. Family, Product or Trade name: for applications related to biocidal products, enter the
complete family, product or trade name (Figure 5b).
9. Looking for: for applications related to biocidal products you can seach for Family product
authorisation or Single product authorisations (Figure 5b).
10. Active substance: for IUCLID applications related to active substances, enter the common
name.
11. Product type: List of the 22 product type as reported in Annex V of the BPR.
12. Submission date “From” and “To”.
13. You can export the selected list of cases in .xls format (excel) by clicking the “Export
(.xls)” button.
Figure 5a: Searching for a case
Figure 5b:
The ‘Case list’ is similar to the ‘Task list’.
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Figure 6: ‘Case list’
How to run BPR processes with R4BP 3 in Member State
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3.4.2 Case details page
Specific information on the cases can be found in the case details page. To display the ‘Case
details’ page (Figure 7) click on one of the case number (Figure 6).
The ‘Case details’ page may contain the following information and tabs, depending on the
application type:
Product or Active substance information and Case owner details are displayed it the upper
part of the ‘Case details’ page. From the “Action” button on the top-right you may either initiate an Ad-hoc communication
or download the Case in .pdf format.
Tabs:
1. Reference details
2. SPC tab: The latest submitted SPC file in case of Single product application or the
structure of the latest submitted family SPC file in case of family product applications.
3. Dossiers: List of IUCLID dossiers submitted with the case.
4. Company details: Information about the case owner and asset owner for applications
related to biocidal products or Case owner details - Information about the the case
owner for applications related to active substances.
5. Events history: The authority Events history displays all the events occurred from
initial submission to final decision per case.
6. Documents: Displays all exchanged documents between authority and industry
(including documents generated via the ad hoc communication), except for:
submitted IUCLID dossiers, which are listed under the ‘Dossiers’ sub-tab, and
financial related documents (i.e. invoices, credit notes), which are listed under the ‘Financial management’ sub-tab.
By default, documents are sorted according to their creation date.
7. Financial management: Under this sub-tab, the authority user attaches and sends
invoices/credit notes to the case owner (applicant). You can also change the status
of the invoice, e.g. awaiting payment, unpaid, fee paid, credited. 8. Related cases: Information about any case initiated from the context of the presented
case (i.e. child cases) and any other cases that have been initiated from the same
context as the present case (e.g. cases in other Member States for mutual recognition
in parallel, same BP).
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Figure 7: “Case details page”
The screenshot was taken for the case type ‘UA-APP Application for union authorisation’.
Depending on the case type, the case details page may differ slightly from the one in the
screenshot.
3.5 Event history
In this specific tab all the steps of a case are displayed in chronological order. This information
can be filtered by steps or by the date as shown in Figure 8.
The “events history” page is a useful record of all steps in the sequence of events of a process.
The case event history contains useful information for you such as whether the Agency has
accepted or not an application, dossier UUID or the stakeholder who performs a particular
action.
Steps in red italics can be viewed only by administrator users; steps in bold can be viewed by
administrators, authority and industry users.
The events history tab summarising the submissions from industry or the decisions from the
Authority (completion of task items and requests for resubmission) provides also a link to a
page that summarises the details of each submission/decision or a link to the communication
details page.
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Figure 8: Case inventory history page
3.6 Assets
An asset is a positive regulatory decision on an application related mainly to either an AS
(e.g. approval of the AS or a decision on technical equivalence) or a BP (e.g. a national
authorisation, incl. mutual recognitions, or a Union authorisation), or a notification (e.g.
notification of experiment or test).
Searching for assets is similar to searching cases.
Figure 9a: Searching for an asset
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The searchable table depends on the type of asset selected: related to a biocidal product or
an active substance application (figure 9b).
Figure 9b:
The available asset records are displayed in the ‘Assets list’ (Figure 10)
Figure 10: ‘Assets list’
When a product asset is displayed, also the information on the related active substance(s)
is given in the next column. When the asset number hyperlink is clicked, the ‘Asset details’
page is displayed (Figure 11).
Figure 11: ‘Asset details’ page
Please note that the “create a new case” button allows you to short cut
the steps needed to perform certain processes e.g. amendment or
cancellation of an asset (Figure 11).
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The ‘Asset details’ page contains different tabs depending on the asset
type: e.g. the “family info” tab only appears for asset related to product
family authorisation.
Authority users will be able to define, which document will be included
in the final asset when finalising the last task item in the workflow
before the asset is created or changed. Additionally will also be able to
manage this document afterwards from the asset tab.
3.7 Case types
An list of BPR processes called ‘case types’ in R4BP 3 can be found in the table of content
of this manual. These processes are described in detail in sections 4 to 47. In addition, a
section on settlement of disagreements is included (Section 28). This process is not a
separate one in R4BP 3 but is relevant for the finalisation of certain processes and this is
the reason why it is included in the present manual.
The processes not relevant for MSCAs are not described in this manual. Information on these
processes can be found however on the ECHA website dedicated to R4BP 3 submissions and
in the appropriate submission manuals for industry also available from the ECHA website.
R4BP 3 does not include all BPR processes. It is foreseen that the missing processes
will be incorporated in future releases. Meanwhile if some of these processes are
necessary, they will be implemented by ECHA in the form of a work around (WA).
3.8 Claiming and completing a task
Under the ‘TASKS’ tab, search for the open tasks in combination with any relevant search
criterion. Click on the task listed as ‘MSCA accept, I - Initiator. The screenshot below provides
an example for ‘MSCA accept I’ (Figure 13). Please keep in mind that for certain processes
the first step is “Validate” (Figure 18)
Step 1: Click on the ‘TASKS’ tab
Step 2: Search for the relevant task, e.g. using the product name and/or case type, i.e.
national authorisation, mutual recognition in sequence, etc.
Step 3: After selecting relevant tasks, click on ‘Search’.
Step 4: Select the task you want to work on.
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Figure 12: ‘TASKS’ page
Claim a task by selecting ‘Start working’. The task is then automatically assigned to you and
its status is changed to ‘Claimed’ (Figure 13).
Figure 13: ‘MSCA accept’ page
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Figure 14: ‘MSCA accept’ page, release the task function.
As soon as you have claimed the task, you become the user to finalise
it. If you need to release the task in order to be claimed by other users
(a member of yours or of another institution/ministry) you have the
choice to ‘release’ (
Figure 14) the task. By doing this the status is automatically changed
back to ‘Unclaimed’. Releasing a task can be necessary if the claimant
is absent while the task needs to be completed urgently.
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Figure 15: ‘MSCA accept’ page 1/2
Step 1: Provide your decision by selecting “Accept” or “Reject” from the drop-down list
as also explained in section 3.12.
Step 2: Insert a message to the case owner.
Step 3: Upload the relevant document(s).
Step 4: Select type of document you want to upload, language of the document and level
of access (Public, Restricted, Restricted-Authority).
Step 5: Provide any comment. Please note that the comments inserted are only for
internal review.
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Step 6: Complete the task actions and finalise your task item by clicking on ‘complete’
(Figure 16).
The complete button is disabled until the mandatory fields, marked with an
asterisk ( ), have been filled in correctly.
Figure 16: ‘MSCA accept’ page 2/2
Click ‘Continue’ to process the task (Figure 17).
Figure 17: ‘Complete task confirmation’ page
At the end of a process, the applicant receives a message indicating the outcome of the task.
If necessary, a task item to be completed by the applicant might be generated, e.g. if you
request additional information.
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Figure 18: ‘Validate’ page of the “Validate” task.
Figure 19: ‘Evaluate’ page of the “Evaluate” task.
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Figure 20:‘Evaluate & Decide’ page of the “Evaluate & Decide” task.
Figure 21: Management of SPC files.
When more translated SPCs are uploaded, the user needs to define the SPC considered as
master SPC. If only one SPC is provided, the available SPC is by default the master SPC.
A master SPC identifies the SPC used as a reference to determine what key information of
your application shall be displayed in R4BP 3.
The Competent Authority can upload the final master SPC and any relevant translations in
the “Evaluate & Decide” step.
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This area enables the authorities to define the master SPC. You can also amend an asset
(using NA-AAT) and define the SPC file(s) that supports the authorisation after it is granted
in R4BP 3 (see section 3.8.2).
Figure 22: Management of asset document.
This area enables the authorities to define the documents (like PAR, CAR) that will be
attached to the final decision. You can also manage them afterwards through those case
types that support changes in the asset context (e.g. NA-AAT).
3.8.1 SPC
SPC is the acronym for Summary of Product Caracteristics and it’s required by the BPR in
almost every process dealing with authorisations (see table 2).
The manual on how to compile the SPC editor can be downloaded here.
A SPC is always available for you in R4BP 3. The SPC available in R4BP 3 is the starting point
for you to work with. R4BP 3 allows you to download a SPC from the case context, i.e., an
on-going application, or from the asset context, i.e., amendment of a national authorisation.
You must download the SPC provided in the application, insert (potential) missing data and
upload the final SPC in R4BP 3 before finalising the task. Depending on the case type, R4BP
3 will require you to upload the final SPC (see table 2).
Mini-SPCs are available in the following scenarios:
- Cases and assets migrated from R4BP 2; and
- Cases and assets submitted via R4BP 3 prior to 2 December 2014.
Mini-SPCs are SPC templates with minimum information, i.e., active substance and PT
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combination; that ensure the appropriate handling of SPCs in R4BP 3 of already existing data
before the SPC became a central part of R4BP 3 in December 2014. These SPCs need to be
replaced by complete SPCs before further actions can be completed (e.g. changes, mutual
recognitions or same product authorisations).
Mini SPCs do not have all the information required in a product authorisation. It is important
to ensure that the SPCs available in R4BP 3 as mini SPCs are completed: if not completed
there may appear authorisations in R4BP 3 without important information like e.g. the AS
name.
Furthermore, by late 2017 the content of the SPC will be disseminated by ECHA (as per
decision of the CA meeting, document CA-Nov15-Doc.4.8) and the content of each SPC should
be completed before being disseminated.
A complete SPC can be added to an authorisation trough the relevant XX-AAT case types. The
terms and conditions of a national authorisation can be found in the SPC available in the
asset. R4BP 3 replaces the content of the SPC in the reference asset based on the latest
successfully “Closed – Approved” change in R4BP 3. If several changes apply to an asset at
the same time, the applicant needs to carefully consider adding up the latest changes in the
latter submission since, once approved, the SPC of the latest “Closed-Approved” case will
determine the terms and conditions available in the SPC. The <Compare with> functionality
in the SPC editor will help you in assessing what new information is added to the SPC of the
latter case.
The final SPC must not include confidential information, as it will be publicly available.
The final SPC is composed of information transferred from R4BP 3 and the SPC file. More
precisely R4BP 3 will transfer the following information: authorisation number, reference
number, authorisation date, expiry date. Furthermore, the following information on the
authorisation holder will be automatically completed: UUID, name, address, postal code, city
and country.
The following table summarises in which processes (case types) related to authorisations a
SPC is needed in the application. A list of definitions of case types is available in the table of
contents of this document.
Table 2: Case type and SPC correlation table
Case type SPC Case type SPC Case type SPC
NA-APP Yes NA-BBS Yes SA-NPF Yes
NA-MRP Yes NA-NPF Yes SA-CAT No
NA-MRS Yes SA-APP Yes SA-AAT amend
NA-RNL Yes (optional)* SN-NOT Yes PP-APP No
NA-CAT No SN-AAT amend PP-AAT No
NA-AAT amend** SN-CAT No PP-CAT No
NA-ADC Yes SA-ADC Yes UA-APP Yes
NA-TRS Yes SA-TRS Yes UA-BBP Yes
NA-MRG Yes SA-MIC Yes NE-NOT No
NA-MIC Yes SA-MAC Yes SE-NOT No
NA-MAC Yes SA-BBP Yes UP-APP Yes
NA-BBP Yes SA-BBS Yes ET-NOT No
NA-CCL No UA-MAC Yes
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* optional means that the SPC is not mandatory but it is suggested
** amend means that the SPC can be submitted by the CA when amending a NA, SA or PP.
The uploaded SPC will not be visible in the newly created case until the case has
passed the ECHA business rules check (BRC).
The following file types are supported: doc/docx/pdf/xls/xlsx/ppt/txt; maximum
file size is 3GB.
3.8.2 Handling SPC families in R4BP 3
With the release of SPC Editor 2.0, the meta SPC concept has been introduced for a family
SPC.
A meta SPC is a structure of a group of products within a family with a similar composition,
similar uses, same hazard and precautionary statements and a common set of first aid
instructions, disposal, storage and shelf life. For information on the tasks performed by the
applicant please refer to the SPC Editor manual available on ECHA webpage.
A BPF (biocidal product family) can consist of one or more meta SPCs, a meta level might
consist of one or more products.
As part of a biocidal product family application, an applicant needs to include a meta family
SPC containing all members for which an authorisation is sought.
The eCA needs to download the family meta SPC available in the application, edit it and upload
it as part of the final SPC before a national or union authorisation is granted. As a result, R4BP
3 will generate an asset number ending in -0000 related to the family meta SPC and asset
members starting with the same root and ending in 0001, -0002, -0003 for each member of
the family.
The guidance document for implementing of the new concept of biocidal product families is
available on CircaBC (CA-Nov14-Doc.5.8 – Final.rev3).
3.8.3 File migration from SPC 1.0 to SPC 2.0
As a result of the adaptation to the new family structure, ECHA:
- migrated all existing family SPCs in R4BP 3 to the new family structure; and
- updated the SPC online editor to allow structured family applications.
ECHA carried out the automatic migration of existing SPCs for family applications in the
cases/assets available in R4BP 3. The automatic migration process ensures that no data
previously contained in SPCs is lost. However some adaptations may have to be applied to
family SPC anytime R4BP 3 requires their upload in a specific case type. This may happen for:
1) on-going cases where applicants have followed the workaround solution proposed
by ECHA in July 2015 and the new family structure has not been provided yet in
structured format; or
2) when information available in the SPC had to be duplicated.
For point one if there are family cases without any member, the system will add one meta
level and one ‘empty’ product in the converted family SPC. In this scenario you will need to
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add all the relevant information for the product in the third level of the SPC which appears
empty after the migration.
If there are family assets without any member, the system will create one meta level and one
new member asset in the converted family SPC. In this case as well you will need to add all
the relevant information for the product in the third level of the SPC, which will appear empty
after the migration, by amending the asset with an XX-AAT.
Point two implies that when updating the new family SPC, you will also need to pay special
attention to the removal of any possible duplicates of information, which were necessary in
order to avoid loss of data in the migration procedure. More in detail, please check the
following fields at family level:
1) Manufacturers of the product
2) Manufacturers of the substance and at meta-SPC level
3) Authorised uses
4) General instructions for use
Please check also the content of the field “Other information” where the trade names that
used to be in the old family SPC are migrated as free text.
In any case for the migration to be finalised, for all open cases, you will have to download the
family SPC, and upload it as part of the final SPC. In the Evaluation step, the eCA needs to
download the existing family SPC (evaluate it) and then upload it in order to finalise the
migration. Furthermore for already authorised assets, you may update the migrated SPCs by
using the amendment for authorisations (XX-AAT) case types in R4BP 3. A consultation with
applicants via ad hoc communication may be recommended, in order to give them the chance
to update the SPC.
Please consider that if there were cases or assets containing family SPC in
language A and member SPCs in language B, the system will generate as many
family SPCs as many different languages were present in the old SPC package
(family and member SPCs). Choose only one of them before finalising any
relevant task.
No changes will apply to SPCs for applications for single biocidal products.
3.8.4 Agreeing on and replacing the SPC
In all those processes where an exchange of SPC among CAs is needed before the final
approval/non approval of the application (NA-MRP, NA-MRS, NA-RNL, NA-MIC, NA-MAC,
SA-MIC, SA-MAC and UA-MAC) the RMS/cMS can exchange the draft SPC, for the purposes
of agreeing on the SPC, via ad hoc communication (see section 3.10). The same approach
can be used to agree on the final SPC with the applicant in relevant cases (if the agreed SPC
is requested via the request additional info task the action will “stop the clock” as described
in section 3.9).
The final, agreed SPC in .xml format, must be uploaded by the CA before finalising the EVL
task (Figure 21). If the SPC of an authorisation needs to be amended, the final SPC can also
be uploaded, at a later stage, by the CA using the relevant XX-AAT case types (“amend” case
type in Table 2).
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3.9 Request additional information with resubmit task
This task needs to be used when the BPR allows additional information to be requested
and a “stop the clock” process is foreseen.
Step 1: Search for the relevant task, e.g. using the product name and/or case type.
Step 2: Claim the task by selecting ‘Start working’.
Step 3: Select ‘Request additional Info’ in the field ‘Please select one of the following
allowed actions based on your decision’ (Figure 23).
Figure 23: ‘Provide your decision page’1/2
Step 4: Type a message to the applicant and set the due date for when your request needs
to be completed (Figure 24).
Step 5: In addition to the field “Message to the owner”, you may also upload a document
describing your request for additional information, set the language in which the
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request is written and put the relevant classification type (Figure 26)
Step 6: Complete the task.
Figure 24: ‘Provide your decision page’2/2
The following file types are supported: doc/docx/pdf/xls/xlsx/ppt/txt;
maximum file size is 3GB.
3.10 Ad hoc communication (New communication)
An ad hoc communication (also known as new communication) may be used to
Member States and ECHA about decisions taken by a MSCA or to create a task for
applicant for which no submission of data by the applicant is necessary (e.g. to
the payment of an invoice or exchange a SPC .xml file). Using the financial tab (
Figure 27) will generate only a message to the applicant; using the ad hoc communication
will also create a task to the applicant.
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Step 1: Search for the relevant case, e.g. using the product name and/or case type (Figure
5 a,b).
Step 2: In the relevant ‘Case details’ page, press the ‘Actions’ button and select ‘New
communication’ (Figure 7).
Step 3: Fill in the requested fields in the ‘Ad hoc communication’ box to create a new
communication. In the field ‘Topic’, select the best fitting option.
Figure 25: Select the Topic’ page
For authority users, only some subjects from the dropdown menu are
relevant, e.g. evaluation, ad hoc invoicing, comments, opinion, SPC,
product sameness and validation.
Step 4: Tick the box ‘Reply required’ and set the appropriate deadline in days. Only
when the box ‘Reply required’ is ticked a task to the recipient will be
created. In other cases, the message will be delivered to the Messages tab.
Step 5: By selecting the click box “reply required” and pressing ‘Send’ the communication
is forwarded to the applicant, the appropriate MSCAs or to ECHA. A task will be
created for the user to which you have sent your communication.
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Under the ‘Events history’ sub-tab in the ‘Case details’ page (Figure 8), you can see that
the message was sent out.
The documents you attached to the ad hoc communication are accessible via the
‘Documents’ sub-tab in the ‘Case details’ page.
Step 6: Click ‘Continue’ to proceed.
With the ad hoc communication in R4BP 3, no IUCLID dossier or SPC
can be requested (and be update automatically). Should you require a
IUCLID dossier or an amended SPC from the applicant, you need to
use the ‘Request additional information’ with the resubmit task (section
3.9).
Choose the topic ‘Comment’ in the topic field, if no better selection is
available in the dropdown menu.
The ‘Request additional information’ function (section 3.9) stops the
clock and puts on hold the running time the MSCA has for a task (legal
period). Therefore, to ask for clarification to resolve small
inconsistencies in the dossier, or in all cases where a stop of the clock
is not foreseen by the BPR, the MSCA may use the ad hoc
communication, which does not have any effect on the task duration
and does not trigger the possibility for resubmission of a IUCLID file.
With the ad hoc communication you can request an SPC in .xml format
but it will not be uploaded automatically. You still need to upload it
manually before approving the case.
The following file types are supported: doc/docx/pdf/xls/xlsx/ppt/txt;
maximum file size is 3 GB.
3.11 Invoicing, financial information
The creation of national invoices is out of the scope of R4BP 3.
Therefore, each MSCA should use its own system to prepare invoices.
However, R4BP 3 needs to be used for sending the invoice to the
applicant and to record the status of the payments.
MSCA should invoice only after a relevant task has been created by the
system e.g. “MSCA accept” or “Validate”. By failing to do so there is a
risk that an invoice is sent before the previous step is actually
completed and the invoice have to be refunded if the application is
rejected in the previous step.
Step 1: Search for the relevant case, e.g. using the product name and/or case type.
Step 2: Open the ‘Case details’ by clicking on the case number hyperlink.
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Step 3: Under ‘Case details’, select the ‘Financial management’ sub-tab.
Figure 26: Case details – Financial management tab’ page
Step 4: Under ‘Financial management’, click the ‘Upload invoice’ button in the ‘Handle
invoices’ section (
Step 5: Figure 27).
Figure 27: ‘Financial information’ page
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Step 6: Fill in the fields and upload the pdf file of your original invoice. Choose the
language in which the invoice has been created (Figure 28 and Figure 29).
Figure 28: ‘Upload new invoice’ page
Figure 29: ‘Upload new invoice’ page, select language
Step 7: Click ‘Send’ in order to send the invoice to the applicant (Figure 30).
Figure 30: ‘Financial information - send’ page
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Step 8: Click ‘Continue’ to proceed.
Figure 31: ‘Confirmation message’ page
Step 9: Once you have received the payment, change the fee status from ‘Awaiting
payment’ to ‘Fee paid’ in the ‘Financial management’ sub-tab of the relevant case
(Figure 32). The applicant will be informed automatically via R4BP 3.
Figure 32: ‘Financial information – handle invoices – Fee paid’ page
Step 10: If the fee has not been paid within 30 days, change the fee status to ‘Fee unpaid’
in the ‘Financial management’ tab of the relevant case (Figure 33). According to
the BPR, the application is to be rejected if the fees are not paid within 30 days.
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Figure 33: ‘Financial information – handle invoices – unpaid’ page
For all national processes (i.e. except those relevant at Union level), you can reject a case
yourself, if the payment is not done within 30 days.
For processes related to Union level, an ad hoc communication needs to be sent to ECHA
requesting the rejection of the application due to non-payment of the invoice. ECHA will then
reject the application in R4BP 3.
Processes at Union level include: active substance approval (including renewal, amendment
and review of active substance approval) and Union authorisation of biocidal products
(including a change, authorisation of the same and renewal of Union authorisation).
Cancelling and changing invoices can be recorded by setting the status of the invoice to
‘Credited’. You can then upload the credit note and the corrected invoice. By clicking ‘Send’,
both documents are sent to the applicant.
3.12 Acceptance, validation, evaluation,
approval/rejection
Generally, the workflow of biocides processes follows the pattern of acceptance, validation,
evaluation and ends resulting in an approval, non-approval or a rejection of an application.
Rejection can be the outcome at any of the steps. Please note that these terms are not
related to legal acts (decisions, regulations) but only to the applications themselves.
Acceptance is the first step in the processing of an application and it is finalised once the
payment is received. If an invoice is not paid within the given deadline, the application will
be rejected at this stage. The acceptance step has to be finalised within the 30 days deadline.
The validation is understood to be a verification step to ensure the application is complete.
The time for the MSCAs to finalise the validation step is usually 30 days from acceptance
date. More information on which issues need to be validated is described in the sections of
the specific processes in this manual. If the application is found to be invalid, a request for
additional information can be made that must be completed by the industry user within a
defined deadline. In some processes, the validation step was used for confirmation whether
the full evaluation is needed or not.
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The evaluation of the applications follows the validation step. Once the validation is
finalised, the evaluation of the application can start. The evaluation time of the eCA (or the
rMS) depends on the process. If further information is needed during this step, a request
for additional information can be made that must be completed by the industry user within
a defined deadline. This action will “stop the clock” and the eCA (or the rMS) will need to
specify the deadline industry has to comply with the request.
Approval is the positive outcome of the process after the evaluation step (for those case
types managed by the MSCA). For cases having SPC the authority user should further review
and update, if required, the SPC package (in the correct .xml format) of the final SPC files
attached for the specific case.
Non-approval is the negative outcome of the process after the evaluation step (for those
case types managed by the MSCA).
Rejection is a negative outcome, that can occur in the acceptance, the validation or the
evaluation steps. Rejection is appropriate to use in cases of non-payment of the fee or failure
to submit additional information requested by the authority (where this is justifiable by the
legislation).
To approve, non-approve or reject an application in R4BP 3, select the appropriate option
from the drop-down menu of the relevant task page and upload the decision and, where
relevant, the appropriate documents (e.g. SPC). Complete the task page to move to the
following task or to close the application.
Applications for approval of active substances and for Union
authorisation of biocidal products can only be approved or non-
approved by Commission in R4BP 3.
If the applicant fails to pay the fee within the 30-day deadline, the
MSCA should reject the application and complete the task or inform
ECHA if it relates to an application for which a MSCA cannot reject.
3.13 Business rules – quality of dossiers
Before applications are accepted by ECHA they pass through the ECHA submission pipeline.
This includes a virus check, format validation and a check of process specific business rules.
It also applies for resubmit tasks when a new dossier is required (request for additional
information).
You can find more information on the submission to ECHA in Chapter 6 ‘How ECHA handles
your submission’ of the Biocides Submission Manual - Technical guide: using R4BP 3 for
biocide applications directed at applicants.
3.14 Classification of documents – Access level
Authorities have to classify the documents they upload:
Public: meaning that the document may be disseminated as uploaded and visible to
both industry and authority users in the asset/case/task/message context that it is
uploaded in.
Restricted: meaning that the document is visible to both industry and authority users
in the asset/case/task/message context in which it is uploaded, but it will not be
disseminated as uploaded.
Restricted – Authority: meaning that the document is only visible to authority users in
the asset/case/task/message context in which it is uploaded and will not be
disseminated as uploaded
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Important note about the access level: When uploading your supporting
documents in the R4BP 3, you are required to indicate an ‘access level’ as
either ‘public’, ‘Restricted’ or ‘Restricted to Authority’. The ‘access level’ is
purely indicative and is in no way binding on ECHA.
3.15 What to do if you need support
ECHA offers a dedicated service to the MSCAs in using the Agency’s information systems
and performing their duties in the context of the BPR.
You can address your questions via the contact form:
https://comments.echa.europa.eu/comments_cms/MSCA_ITsupport_form.aspx
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AS-APP Active substance approval
4.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
4.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
4.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
4.4 Steps to be followed by the MSCA
The eCA needs to claim the task during the approval process and can request further
information through the task item.
Step 1: Claim the ‘Validate’ task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11). If the fee is not paid within 30 days reject the application (see section 3.12)
Step 3: Complete the actions in the “Validation” page (Figure 18).
Validate the application within 30 days of receiving the task from ECHA according to BPR
Articles 7(3). This validation includes verifying whether:
a. the information requirements for the active substance are fulfilled;
b. the information requirements for the representative product(s) are fulfilled;
c. BPR Article 5(2) is applicable if exclusion criteria are met according to BPR Article
5(1);
d. Justifications have been submitted for the adaptation of information requirements.
The validation should not include an assessment of the quality or the adequacy of the data
or justifications submitted.
e. If the information requirements are fulfilled, complete the validation task and
follow on with Step 4.
f. If the information requirements described above are not fulfilled, inform the
applicant what additional information is required for validating the application
(further information in sections 3.9). Set a reasonable time limit for the submission
of the additional information. This shall normally not exceed 90 days.
g. Validate the application within 30 days of receipt of the additional information. Reject the application if the applicant fails to submit the requested information
48
within the deadline or the information requirements remain incomplete. In such
case, part of the fees paid by the applicant to the eCA may need to be reimbursed.
Step 4: Claim the “Evaluate” task and complete the actions in the “Evaluation” page
(Figure 19).
Evaluate the application within 365 days (BPR Article 8(1)). The following tasks related to
R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID2 file where relevant.
b. via the request additional information function you can request further information
and stop the clock. Set a reasonable time limit for the submission of the additional
information. This shall normally not exceed 180 days. Reject the application (see
section 3.12) if the applicant fails to submit the requested information within the
deadline. The applicant will be automatically notified.
c. Inform ECHA via ad hoc communication (see section 3.10) as soon as possible on
issues identified that may need to be discussed at a working group meeting already
before submitting the competent authority report (CAR) and the dossier enters
the peer review phase.
d. Inform ECHA via ad hoc communication if the active substance is a potential
candidate for substitution.
e. Perform confidentiality claims check by evaluating the justifications submitted by
the applicant.
f. According to the ECHA’s procedures it is suggested that not later than 60 days
before the end of the 365-day evaluation period, the eCA would send the CAR and
conclusions for a 30-day commenting period to the applicant. Reply to the
applicant’s comments and adapt the CAR accordingly if necessary.
Step 5: Peer review
Send the CAR to ECHA for initiation of the peer review stage. According to the
“Working procedure for active substance approval”, Table 1, the CAR should be
submitted via R4BP 3.
4.5 Supporting documents
Template agreement to act as CA.
AS-EVA Active substance evaluation under Directive
98/8/EC
5.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
2 Guidance on IUCLID is available on ECHA website here: https://iuclid6.echa.europa.eu/support.
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5.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
5.3 Application requirements
This process derives from the assessment of the existing active substances under the BPD
and is supported by Article 90 of the BPR and the Review Programme Regulation (EU) No
1062/2014. The only application requirement is for the active substance to be in the review
programme. All AS/PT combinations have been created in R4BP 3. The case owner is either
the participant or the task force leader. The management of participants (Article 95 list
management) takes place outside R4BP 3.
5.4 Steps to be followed by the MSCA
Step 1: Complete the actions in the “Validation” page (Figure 18).
a. If the application is incomplete, inform the applicant that additional information is
required for validation. Through ‘request additional information’ (see section 3.9)
a resubmission task item for the applicant is created. Set a reasonable time limit
for the submission of the additional information. This shall normally not exceed 90
days. Reject the application if the applicant fails to submit the requested
information by the deadline (see section 3.12).
b. If the information requirements are fulfilled, complete the validation task within 30
days of receipt additional information and follow on with Step 2.
c. Reject the application if the applicant fails to submit the requested information by
the deadline (see section 3.12). The applicant and ECHA will be notified
accordingly.
Step 2: Claim the “Evaluate” task and complete the task actions (Figure 19).
Evaluate the application (the Review Regulation sets PT-dependent deadlines – Annex III).
The following tasks related to R4BP 3 can be considered during the evaluation:
a. When relevant, annotate IUCLID file and/or the study summaries.
b. Consult with ECHA via ad hoc communication if additional information is required.
Request additional information (‘stop the clock’) as described in Step 3 b above to
the applicant. If you ‘stop the clock’, please inform ECHA via ad hoc communication
(see sections 3.9).
c. Inform ECHA on issues identified that may need to be discussed at a working group
meeting via ad hoc communication already before submitting the CAR and the
dossier enters the peer review phase.
d. Inform ECHA if the active substance is a potential candidate for substitution via ad
hoc communication.
e. Perform the confidentiality claims check by evaluating the justifications submitted
by the applicant.
f. According to the ECHA’s procedures it is suggested that not later than 60 days
before the end of the evaluation period, the eCA would send the CAR and the
conclusions for a 30-day-commenting period to the applicant. Reply to the
applicant’s comments and adapt the CAR accordingly if necessary.
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Step 3: Peer review
Send the CAR to ECHA for initiation of the peer review stage. According to the
“Working procedure for active substance approval”, Table 1, the CAR should be
submitted via R4BP 3.
AS-NAS New active substance evaluation under Directive 98/8/EC
6.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process. All AS/PT combinations have been created in R4BP 3.
The case owner is either the participant or the task force lead. The management of
participants (Article 95 list management) is lead outside R4BP 3.
6.2 Workflow
MEV > OPN > DEC
6.3 Application requirements
This process derives from the assessment of the new active substances under the BPD and
is supported by Article 90 of the BPR. The only application requirement is that an approval
request was submitted for a new active substance under the BPD.
6.4 Steps to be followed by the MSCA
Please follow the steps 4 and 5 in section 4.4.
6.5 Supporting documents
Template agreement to act as eCA.
AS-RNL Renewal of the approval of an active substance
7.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
7.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
Please note that in this case type the validation task is used by eCA to decide whether a
full evaluation is required or not.
7.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
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7.4 Steps to be followed by the MSCA
See section 4.4
7.5 Supporting documents
Template agreement to act as eCA.
AS-NPT Approval of an active substance in an additional product type
8.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
8.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
8.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
8.4 Steps to be followed by the MSCA
See section 4.4
8.5 Supporting documents
Template agreement to act as eCA (it should be the same eCA of the original dossier).
AN-APP (1-5) Amendment of Annex I
9.1 Introduction
The process relates to the amendment of category 1 to 5 of Annex I to the BPR.
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
9.2 Workflow
BRC > EAA > MAA > MEV > OPN > DEC
9.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
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9.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 3: Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid, accept the application and proceed with Step 4. The
applicant will be notified accordingly by the system.
b. If the fee has not been paid, reject the application. The applicant will be
automatically notified.
Step 4: Claim the “Evaluate” task and complete the actions in the “Evaluation” page
(Figure 19).
Evaluate the application within 180 days. The following tasks related to R4BP 3 can be
considered during the evaluation:
a. via the request additional information function you can request further information
and stop the clock. Set a reasonable time limit for the submission of the additional
information. This shall normally not exceed 180 days. Reject the application (see
section 3.12) if the applicant fails to submit the requested information within the
deadline. The applicant and ECHA shall be notified.
b. Inform ECHA via ad hoc communication (see section 3.10) as soon as possible on
issues identified that may need to be discussed at a working group meeting already
before submitting the competent authority report (CAR) and the dossier enters
the peer review phase.
c. Perform confidentiality claims check by evaluating the justifications submitted by
the applicant.
d. ECHA suggests that not later than 60 days before the end of the 180-day
evaluation period, the eCA would send the CAR and conclusions for a 30-day
commenting period to the applicant. Reply to the applicant’s comments and adapt
the CAR accordingly if necessary.
e. Complete the Evaluate task selecting “Submit evaluation”.
Step 5: Peer review
Send the CAR to ECHA for initiation of the peer review stage. According to the “Working
procedure for active substance approval”, Table 1, the CAR should be submitted via R4BP 3.
9.5 Supporting documents
Template agreement to act as CA.
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AN-APP (6) Amendment of Annex I
10.1 Introduction
The process relates to the amendment of category 6 of Annex I to the BPR.
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
10.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
10.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
10.4 Steps to be followed by the MSCA
The procedure to be followed is the same of AS-APP or AS-EVA. Please See section 4.4.
10.5 Supporting documents
Template agreement to act as CA.
NA-APP National authorisation
11.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
11.2 Workflow
BRC > MAA > VAL > EVL
11.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
11.4 Steps to be followed by the MSCA
The steps described here are not relevant for applications for mutual
recognition in parallel. If you are the rMS for an application, which shall
be mutually recognised in parallel, please refer to section 15.
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
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3.11).
Step 3: Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid, accept the application and proceed with Step 4. The
applicant will be notified accordingly by the system.
b. If the fee has not been paid, reject the application. The applicant will be
automatically notified.
Step 4: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
18).
Validate the application within 30 days of the acceptance date. According to the
BPR (Article 29(2)), the validation includes verifying:
whether the relevant information described in Article 20 of the BPR has been
submitted;
that the statement of the applicant that no application for national authorisation of
the same biocidal product for the same use has been submitted to any other MSCA.
A template is provided by ECHA on the website and should be included in the
application by the applicant as a supporting document.
The validation shall not include an assessment of the quality or adequacy of the
data or justifications submitted.
a. If the information requirements described above are fulfilled, complete and
proceed with Step 5.
b. If the information requirements described above are not fulfilled, inform the
applicant of the additional information that is required for validation. Through
‘request additional information’ (see section 3.9) a resubmission task item for the
applicant is created to submit an updated IUCLID dossier or other file type
supported by the case type wizard.
Set a reasonable time frame for the submission of the additional information which
should normally not exceed 90 days. Validate the application within 30 days of
receipt of the additional information.
Reject the application if the applicant fails to submit the requested information by
the deadline (see section 3.12).
c. If the applicant has already submitted an application for national authorisation for
the same biocidal product and the same use in another Member State, reject the
application and inform the applicant of the possibility of seeking mutual
recognition. As R4BP 3 does not allow checking this by searching the data base at
the moment, this has been implemented by the obligatory inclusion of the above
mentioned supporting document by the applicant.
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Step 5: Claim the “Evaluate & Decide” task
Within 365 days, evaluate whether an authorisation can be granted in accordance
with Article 19 of the BPR. This evaluation step takes place outside R4BP 3. The
following tasks related to R4BP 3 can be performed during the evaluation:
a. Annotate IUCLID file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation. Through ‘request additional information’ (see section 3.9) a
resubmission task item for the applicant is created to submit a new IUCLID dossier
or other file type and it will stop the clock. Set a reasonable period for the
submission of the additional information, which should normally not exceed 180
days in total. Reject the application (see section 3.12) if the applicant fails to
submit the requested information within the deadline. The applicant will be
automatically notified.
c. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for authorising or refusing to grant the authorisation.
Amend if necessary the draft SPC generated by the applicant. Send an electronic
copy of the PAR and the SPC to the applicant through ad hoc communication (see
section 3.10) and provide the opportunity to submit comments within 30 days
(request reply).
d. Finalise the assessment taking into account the comments provided by the
applicant.
e. Perform a confidentiality claims check by evaluating the justifications submitted by
the applicant.
f. Complete the actions in the “Evaluate & Decide” page by selecting “Approve
application” (Figure 20).
Close the task by approving or not approving the application for the product authorisation
(see section 3.12) and at the same time upload the final PAR and SPC to R4BP 3.
The final SPC must not include confidential information, as it will be made
publicly available.
Applications for authorisation of the same biocidal product will appear as
related asset of the reference product (see Article 7 of the Implementing
Regulation (EU) No 414/2013, amended by Regulation No 2016/1802).
Whenever an authorisation is granted or not, the related cases should be
checked as the connections are not automated.
NA-APP (WA) Provisional national authorisation Article 55(2)
12.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
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12.2 Workflow
BRC > MAA > VAL > EVL
12.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
12.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task (see section 3.8).
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 3: Complete the actions in the “MSCA accept” page (Figure 17).
Check in your national invoicing system whether the fee has been paid within 30
days (3a) or not (3b).
a. If the fee has been paid, complete and proceed with Step 4. The applicant will be
notified accordingly.
b. If the fee has not been paid, reject the application. The applicant will be
automatically notified.
Step 4: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
18).
Validate the application within 30 days of the acceptance date. According to the
BPR (Article 29(2)), the validation includes verifying:
i. whether the evaluating competent authority has given a recommendation
for approval in the CAR (please check the CAR uploaded in the R4BP 3 or
CIRCA BC page under the new active folders);
ii. whether the relevant information described in Article 20 of the BPR has
been submitted;
The validation shall not include an assessment of the quality or adequacy of the
data or justifications submitted.
a. If the information requirements described above are fulfilled, complete and proceed
with Step 5 by selecting “Validate”.
b. If the information requirements described above are not fulfilled, inform the applicant
of the additional information that is required for validation. Through ‘request additional
information’ (see section 3.9) a resubmission task item for the applicant is created to
submit an updated IUCLID dossier.
i. Set a reasonable time frame for the submission of the additional information
which should normally not exceed 90 days. Validate the application within 30
days of receipt of the additional information.
ii. Reject the application if the applicant fails to submit the requested information
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by the deadline (see section 3.12).
c. If the applicant has already submitted an application for national authorisation for the
same biocidal product and the same use in another Member State, reject the
application and inform the applicant of the possibility of seeking mutual recognition.
As R4BP 3 does not allow checking this by searching the data base at the moment,
this has been implemented by the obligatory inclusion of the above mentioned
supporting document by the applicant.
Step 5: Claim the “Evaluate & Decide” task
Evaluate whether an authorisation can be granted in accordance with Article 19 of the
BPR. The duration of the evaluation period is still under discussion by the COM services.
The following tasks related to R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation. Inform the applicant what additional information is required. Through
‘request additional information’ (see section 3.9) a resubmission task item for the
applicant is created to submit a new IUCLID dossier or other file type and it will
stop the clock. Set a reasonable period for the submission of the additional
information which should normally not exceed 180 days in total.
Reject the application (see section 3.12) if the applicant fails to submit the
requested information within the deadline. The applicant will be automatically
notified.
c. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for authorising or refusing to grant the authorisation.
Amend if necessary the draft SPC generated by the applicant.
d. Perform a confidentiality claims check by evaluating the justifications submitted by
the applicant.
e. Send an electronic copy of the PAR and the SPC to the applicant through ad hoc
communication (see section 3.10) and provide the opportunity to submit
comments within 30 days (request reply). Finalise the assessment taking into
account the comments provided by the applicant.
f. Complete the actions in the “Evaluate & Decide” page by selecting “Approve
application” (Figure 20).
Close the task by approving or not approving the application for the product
authorisation (see section 3.12) and the same time upload the final PAR and SPC
to R4BP 3.
The final SPC must not include confidential information, as it will be publicly
available (see section 3.8.1).
Applications for authorisation of the same biocidal product will appear as
related asset of the reference product (see Article 7 of the Implementing
Regulation (EU) No 414/2013, amended by Regulation No 2016/1802).
Whenever an authorisation is granted or not, the related cases should be
checked as the connections are not automated.
* The duration of the evaluation period is still under discussion within the COM
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services.
NA-RNL Renewal of National authorisation
13.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
13.2 Workflow
BRC > MAA > VAL > EVL
13.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
MSCAs need to determine whether they are rMS or cMS.
13.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Check that there is no supporting document in the document tab and proceed
directly with Step 3. In case there is a supporting document this means that the
case refers to a mutual recognition renewal and you should refer to section 14.
Step 3: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 4: Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid accept the application and proceed with Step 4. The
applicant will be notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.12) and inform
the applicant accordingly through ad hoc communication (see section 3.10).
Similarly, inform the rMS if relevant (if a supporting document is present in the
application).
Step 5: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
18).
Decide within 90 days of accepting an application whether a full evaluation of the
application for renewal is necessary taking account of all product-types for which
renewal is needed. A tick box is provided in R4BP 3 to support this option.
Step 6: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
In case a full evaluation of the application is necessary, evaluate it within 365 days whether
a renewal of an authorisation can be granted in accordance with Article 30 of the BPR. This
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evaluation step takes place outside R4BP 3. The following tasks related to R4BP 3 can be
performed during the evaluation:
a. Annotate IUCLID file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation. Through ‘request additional information’ (see section 3.9) a
resubmission task item for the applicant is created to submit a new IUCLID dossier
or other file type and it will stop the clock.
c. Set a reasonable time frame for the submission of the additional information which
should normally not exceed 180 days in total. Reject the application (see section
3.12) if the applicant fails to submit the requested information within the deadline.
The applicant will be automatically notified.
d. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for authorising or refusing to grant the authorisation.
Amend if necessary the draft SPC generated by the applicant.
e. Send an electronic copy of the PAR and SPC to the applicant through ad hoc
communication (see section 3.10) and provide the opportunity to submit
comments within 30 days (request reply). Finalise the assessment taking into
account the comments provided by the applicant.
In case a full evaluation of the application is not necessary evaluate it within 180 days of
accepting the application.
Complete the actions in the “Evaluate & Decide” page by selecting “Approve application”
(Figure 20).
Close the task by approving or not approving the application for the renewal of national
authorisation (see section 3.12) and at the same time, if relevant, upload the final PAR and
SPC to R4BP 3.
The final SPC must not include confidential information, as it will be publicly
available (see section 3.8.1).
NA-RNL Renewal of National authorisation subject to mutual recognition
14.1 Introduction
This is in practice the same case type used for single product authorisation renewal except
that the applicant will request in a single submission the renewal of all (or some) the assets
related by mutual recognition. Communication with concerned MSCA is therefore needed.
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
14.2 Workflow
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14.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
MSCAs need first to determine whether they are rMS or cMS by checking the
supporting document.
The grouped submission of renewal application is the principle introduced by
the Commission Regulation No 492/2014 in order to avoid unnecessary
duplication of the evaluation procedures by the Competent Authorities (CA).
This practical approach is also recommended for the sake of consistency during
the evaluation process. However, in case of mutually recognised
authorisations, which have different Authorisation Holders the grouped
submission is not mandatory and up to the Authorisation Holder choice to
nominate another company making the grouped application for renewals.
In case companies decide to submit the applications for renewal separately,
these separate applications may not be linked together and could therefore be
evaluated separately by the (possibly different) receiving MSs as it is described
in Article 31 of the BPR (taking into account exceptions for biocidal products
containing chlorophacinone, bromadiolone or coumatetralyl).
Note also technical limitations explained below due to which two or more
submissions may need to be combined for evaluation by a single rMS under
the Commission Regulation No 492/2014.
14.4 Steps to be followed by the reference MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: A supporting document (Renewal of authorisation subject to mutual recognition)
should be present under the Documents tab. If there is no supporting document
this means that the case refers to a renewal not involving any mutual recognition
and you should refer to section 13.
Step 3: If there is such supporting document, check in the supporting document whether
you are rMS or cMS. Please note that this information or the related cases cannot
be read from the case details. Furthermore, since there may be missing links in
the R4BP 3 database among the related NA assets, applicants may need to apply
under the regulation 492/2014 in more than one submissions. The kind of
submission (main or additional) can be deduced from the supporting document(s).
The rMS is given by the asset from which the applicant starts the main submission.
The additional submissions cover related assets that could not be included in the
main submission for which the corresponding competent authorities become cMSs.
In order to ensure the information on the rMS/cMS and the additional submissions
is available to all rMS/cMS and to potentially enable their combined assessment
with the main submission, ECHA will send the supporting documents of the main
and additional submissions to the rMS and the cMS through ad hoc communication.
For cMS next steps refer to section 14.5.
Step 4: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
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Step 5: Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid accept the application and proceed with Step 6. The
applicant will be notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.12). The applicant
will be notified accordingly. Inform the concerned CA through ad hoc
communication (see section 3.10).
Step 6: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
18).
Within 30 days of the acceptance in the reference Member State, that Member
State shall validate the application if it contains all the relevant information
referred to in Article 2.
a. If the information requirements described above are fulfilled, select “Validate”
complete and proceed with Step 6.
b. If the information requirements described above are not fulfilled, request additional
information (section 3.9) and set a reasonable period for the submission of the
additional information, which should normally not exceed 90 days in total.
c. Select “reject” if the additional information are not sufficient to validate the
application.
d. Decide within 90 days of accepting an application whether a full evaluation of the
application for renewal is necessary taking account of all product-types for which
renewal is requested. A tick box is provided in R4BP 3 in the validation page to
support this option. The reference CA must send an ad hoc communication to the
concerned CAs to inform them about the evaluation type of their choice.
Step 7: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
In case a full evaluation of the application is necessary, evaluate it within 365 days* whether
a renewal of an authorisation can be granted in accordance with Article 30 of the BPR. The
following tasks related to R4BP 3 can be considered during the full evaluation:
a. Annotate IUCLID file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation. Through ‘request additional information’ (see section 3.9) a
resubmission task item for the applicant is created to submit a new IUCLID dossier
or other file type and it will stop the clock. Set a reasonable time frame for the
submission of the additional information which should normally not exceed 180
days in total. Reject the application (see section 3.12) if the applicant fails to
submit the requested information within the deadline. The applicant will be
automatically notified.
c. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for renewal or refusing to renew the authorisation.
Amend if necessary the draft SPC generated by the applicant.
d. Send an the PAR and SPC to the applicant through ad hoc communication (see
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section 3.10) and provide the opportunity to submit comments within 30 days
(request reply). Finalise the assessment taking into account the comments
provided by the applicant.
e. Within 365 days of validating the application, the rMS shall send draft PAR and SPC
through ad hoc communication to the cMS and to the applicant.
*In case a full evaluation of the application is not necessary evaluate it within 180 days of
validating the application. Please note that in this case step 6(b) does not apply.
Agreement by cMS and decision taking:
a. All the cMSs express their position on the draft SPC within 90 days of the receipt
of the draft PAR and SPC from rMS by sending their decision on the agreement
through ad hoc communication to the rMS, the other cMSs and the applicant. If a
cMS expresses a disagreement with the draft SPC and the PAR prepared by the
rMS, the rMS shall refer the detailed explanation of the points of disagreement and
the reasons for position received from the cMS to the Coordination Group without
delay (see section 28).
b. Following the 90 days, the rMS will take a decision on the renewal of the national
authorisation within 30 days and close the task by approving or not approving the
application for the renewal of national authorisation (see section 3.12). The rMS
uploads the agreed SPC and the final PAR in R4BP 3 together with any agreed
terms and conditions on the making available on the market or use of the biocidal
product.
The final SPC must not include confidential information, as it will be publicly
available.
14.5 Steps to be followed by the concerned MSCAs
Step 1: Claim the “MSCA accept” task.
Step 2: Check whether there is a supporting document (Renewal of authorisation subject
to mutual recognition) under the Documents tab (sent to you by ECHA) which
indicates who the rMS and the respective cMSs are. The supporting documents
you receive should be giving you the status of cMS. This information or the related
cases cannot be read from the case details in the R4BP 3.
Furthermore, since there may be incorrect links in the R4BP 3 database among
the NA assets, applicants may need to apply under the regulation 492/2014 in
more than one submissions. The kind of submission (main or additional) can be
deduced from the supporting document(s).
The rMS is given by the asset from which the applicant starts the main submission.
The additional submissions cover related assets that could not be included in the
main submission for which the corresponding competent authorities become cMSs.
In order to ensure the information on the rMS/cMS and the additional submissions
is available to all rMS/cMS and to potentially enable their combined assessment
with the main submission, ECHA will send the supporting documents of the
additional submissions to the rMS and the cMS through ad hoc communication.
Step 3: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
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via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section 3.11).
Step 4: Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid, complete and proceed with Step 4. The applicant will be
notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.12). The applicant
will be automatically notified. Send the information also to the rMS and where
relevant other cMSs through ad hoc communication (see section 3.10) using the
template mentioned in the supporting documents section below.
Step 5: Claim the ‘Validate’ task.
Provided that the rMS has validated the application, within 30 days of the
acceptance the concerned Member State(s) will verify that the application it has
received falls within the scope of the supplementary rules for renewal as per Article
1(2) and (3) of Commission Delegated Regulation (EU) No 492/2014. If not, the
application for renewal must be processed under the regular renewal procedures
set out in Article 31 of the BPR. In this case the MSs shall inform the other
concerned MS via ad hoc communication. Such MS should process the application
following the steps described in section 13.4.
A tick box is provided in this task to indicate which kind of evaluation will be
performed by the rMS and the cMS must select the same evaluation type chosen
by the rMS.
Step 6: Claim the “Evaluate & Decide” task.
In case a full evaluation of the application is necessary, within 365 days* of validating an
application, the rMS shall evaluate the application and draft a PAR in accordance with Article
30(3) and send it together with the SPC through ad hoc communication to the cMSs and to
the applicant.
a. All the cMSs express their position on the draft SPC within 90 day of the receipt
of the draft PAR and SPC from rMS by sending their decision on the agreement
through ad hoc communication to the rMS, the other cMSs and the applicant
using the template from the supporting documents sections below.
b. In case a given cMS agrees with the draft SPC and the PAR (a positive
assessment report), the cMS completes the actions in the “Evaluate & Decide”
page (Figure 20) and renews the authorisation within 30 days of reaching the
agreement in conformity with the agreed SPC and closes the task by approving
the application for the renewal of national authorisation (see section 3.12).
Within 7 days after agreement, SPC should be translated by the applicant in all
applicable languages. The finalised respective language version of the SPC must
be uploaded by the cMS when approving the renewal. (The rMS shall upload
the agreed SPC and the final PAR in R4BP 3 together with any agreed terms
and conditions on the making available on the market or use of the biocidal
product when approving the application for the renewal of national
authorisation.)
Make sure to assign the same expiry date as for the reference product. To find
the expiry date of the reference product go to the related cases tab of your
case’s details page and copy the reference number of the reference product
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(see point 8 of Figure 7). Search for the reference authorisation using this
number.
c. If you disagree with the draft SPC, send a detailed explanation of the points of
disagreement and the reasons for your position to the rMS, the other cMSs, the
applicant and, where applicable, the authorisation holder through ad hoc
communication. This shall be referred by the rMS to the Coordination Group
without delay (see section 28).
d. If you refuse to grant the authorisation of the BP or want to adjust the terms
and conditions of the authorisation to be granted according to Article 37 of the
BPR, and on the grounds of Article 7 of Regulation (EU) No 492/2014,
communicate a detailed statement of the grounds for seeking a derogation to
the applicant via ad hoc communication and seek an agreement. If the
agreement between the two is not reached, the cMS informs COM via ad hoc
communication who takes the final decision.
*In case a full evaluation of the application is not necessary the rMS will evaluate it within
180 days of validating the application. Please note that in this case step 6(b) of section 13.4
does not apply.
The final SPC must not include confidential information, as it will be publicly
available.
14.6 Supporting documents
Template agreement/disagreement on SPC.
NA-MRP Mutual recognition in parallel
15.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
15.2 Workflow
BRC > EAA > MAA > VAL > EVL
15.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
15.4 Steps to be followed by the MSCA
15.4.1 Steps to be followed by the rMS
Step 1: Claim the “MSCA accept” task (see section 3.8).
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Complete the actions in the “MSCA accept” page (Figure 17). Check whether the
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fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid, accept the application and proceed with Step 3. The
applicant will be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application and inform via
ad hoc communication the cMS.
Step 3: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
18). Validate the application within 30 days of the acceptance date in accordance
with Article 29(2) and (3) of the BPR. The validation includes verifying:
whether the relevant information described in Article 20 of the BPR has been
submitted,
the statement of the applicant that no application for national authorisation of the
same biocidal product for the same use has been submitted to any other MSCA. A
template is provided by ECHA on the website and should be included in the
application by the applicant as a supporting document.
The validation should not include an assessment of the quality or adequacy of the data or
justifications submitted.
a. If the information requirements described above are fulfilled, select “Validate”
complete and proceed with Step 4.
b. If the information requirements described above are not fulfilled, inform the
applicant of the additional information that is required for the validation. Through
‘request additional information’ (see section 3.9) a resubmission task item for the
applicant is created to submit a new IUCLID dossier or other file type.
Set a reasonable period for the submission of the additional information which
should normally not exceed 90 days. Validate the application within 30 days of
receipt of the additional information.
Reject the application if the applicant fails to submit the requested information by
the deadline (see section 3.12) and inform the cMS accordingly through ad hoc
communication (see section 3.10) using the template mentioned in the supporting
documents section below.
c. If the applicant has already submitted an application for national authorisation for
the biocidal product with the same use in another Member State, reject the
application and inform the applicant of the possibility of seeking mutual
recognition.
Step 4 Claim the “Evaluate & Decide” task.
Within 365 days of validating the application, evaluate the application whether an
authorisation can be granted in accordance with Article 19. The following tasks related to
R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation. Through ‘request additional information’ (see section 3.9) a
resubmission task item for the applicant is created to submit a new IUCLID dossier
or other file type and it will stop the clock. Set a reasonable time frame for the
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submission of the additional information which should normally not exceed 180
days in total. Reject the application (see section 3.12) if the applicant fails to
submit the requested information within the deadline. The applicant will be
automatically notified.
c. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for authorising or refusing to grant the authorisation.
Amend if necessary the draft SPC generated by the applicant.
d. Perform a confidentiality claims check by evaluating the justifications submitted by
the applicant.
e. Send an electronic copy of the PAR and the SPC to the applicant through ad hoc
communication (see section 3.10) and provide the opportunity to submit comments
within 30 days (request reply). Finalise the assessment taking into account the
comments provided by the applicant.
f. Within 365 days of validating an application, the rMS shall send draft PAR and SPC
(see section 3.8.2 and 3.10) through ad hoc communication to the cMS and to the
applicant.
Agreement by cMS and decision taking:
a. All the cMSs express their position on the draft SPC within 90 days of the receipt
of the draft PAR and SPC from rMS by sending the agreement through ad hoc
communication to the rMS, the other cMSs and the applicant. If a cMS expresses
a disagreement with the draft SPC prepared by the rMS, the rMS shall refer the
detailed explanation of the points of disagreement and the reasons for position
received from the cMS to the Coordination Group without delay (see section 28).
b. Following the 90 days, the rMS will take a decision on the national authorisation,
the rMS grants the national authorisation within 30 days and close the task by
approving or not approving the application for the renewal of national
authorisation (see section 3.12). The rMS uploads the agreed SPC and the final
PAR in R4BP 3 together with any agreed terms and conditions on the making
available on the market or use of the biocidal product (see Figure 24 and section
3.8.2).
15.4.2 Steps to be followed by the cMS
Step 1: Claim the “MSCA accept” task (see section 3.8).
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Complete the actions in the “MSCA accept” page (Figure 17). Check whether the fee has been
paid within 30 days (3a) or not (3b).
a. If the fee has been paid, accept the application and proceed with Step 4. The
applicant will be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application and inform via
ad hoc communication the cMS.
Step 3: Claim the ‘Validate’ task (see section 3.8). Complete the actions in the
‘Validation’ page (Figure 18). Select “validate” or “reject” in line with the decision
of the rMS.
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Step 4: Claim the “Evaluate & Decide” task.
Within 365 days of validating an application, the rMS shall evaluate the application and draft
a PAR in accordance with Article 30(3) and send it together with the SPC through ad hoc
communication to the cMS and to the applicant. Please check the status of the reference asset
to verify the progress of the application.
a. All the cMSs express their position on the draft SPC within 90 days of the receipt
of the draft PAR and SPC from rMS by sending decision on the agreement through
ad hoc communication to the rMS, the other cMSs and the applicant (see section
3.8.2).
b. In case a given cMS agrees with the draft SPC , the cMS, completes the actions in
the “Evaluate & Decide” page (Figure 20) and grant the authorisation within 30
days of reaching the agreement in conformity with the agreed SPC and close the
task by approving the application for granting a national authorisation (see section
3.12). Within 7 days after agreement, SPC should be translated by applicant in all
applicable languages (as requested by the cMS). The finalised respective language
version of the SPC must be uploaded by the cMS when approving the authorisation.
(The rMS shall upload the agreed SPC and the final PAR in R4BP 3 together with
any agreed terms and conditions on the making available on the market or use of
the biocidal product when approving the application for granting a national
authorisation (see section 3.8.2)).
Make sure to assign the same expiry date as for the reference product. To find the
expiry date of the reference product go to the related cases tab of your case’s
details page and copy the reference number of the reference product (see point 8
of Figure 7). Search for the reference authorisation using this number.
c. If you disagree with the draft SPC prepared by the rMS, send a detailed explanation
of the points of disagreement and the reasons for your position to the rMS, the
other cMSs, and the applicant through ad hoc communication. This shall be referred
by the rMS to the Coordination Group without delay (see section 28).
d. If you refuse to grant the authorisation of the BP or want to adjust the terms and
conditions of the authorisation to be granted according to Article 37 of the BPR,
communicate a detailed statement of the grounds for seeking a derogation to the
applicant through ad hoc communication and seek to reach an agreement on the
proposed derogations.
15.5 Supporting documents
Template agreement/disagreement on SPC.
NA-MRS Mutual recognition in sequence
16.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
16.2 Workflow
BRC > EAA > MAA > VAL > EVL
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16.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
16.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task (see section 3.8).
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 3: Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid accept and proceed with Step 4. The applicant will be
automatically notified.
b. If the fee has not been paid, reject the application. The applicant will be
automatically notified (see section 3.12). If there are applications for mutual
recognition in sequence in other Member States, inform the other cMSs accordingly
through ad hoc communication (see section 3.10).
Step 4: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
18).
Validate the application within 30 days of the acceptance date in accordance with
Article 33(2) of the BPR and proceed with Step 5.
Step 5: Claim the “Evaluate & Decide” task.
Within 90 days of validating the application,
a. If you agree on the SPC, record your agreement by sending the agreement
through ad hoc communication to the applicant and, if applicable, to the other
cMSs (see section 3.8.2 on how to agree on the SPC).
In case the cMS agree on the SPC, the cMS complete the actions in the “Evaluate
& Decide” page (Figure 20) and grants the authorisations within 30 days of
reaching agreement in conformity with the agreed SPC and closes the task by
approving the application for the national authorisations (see section 3.12). Before
closing the task, upload the agreed SPC in R4BP 3 (see section 3.8.2). Within 7
days after agreement, SPC should be translated by applicant in all applicable
languages (as requested by the cMS). The finalised respective language versions
of the SPC must be uploaded by the cMS when approving the authorisation.
Make sure to assign the same expiry date as for the reference product. To find the
expiry date of the reference product go to the related cases tab of your case’s
details page and copy the reference number of the reference product (see point 8
of Figure 7). Search for the reference authorisation using this number.
b. If you consider that the BP assessed by the rMS does not meet the conditions laid
down in Article 19 of the BPR, send a detailed explanation of the points of
disagreement and the reasons for your position to the rMS, the other cMSs, and
the applicant through ad hoc communication. This shall be referred by the rMS to
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the Coordination Group without delay (see section 28).
c. If you refuse to grant the authorisation of the BP or want to adjust the terms and
conditions of the authorisation to be granted according to Article 37 of the BPR,
communicate to the applicant a detailed statement of the grounds for seeking a
derogation through ad hoc communication and seek to reach an agreement on the
proposed derogations.
16.5 Supporting documents
Template agreement/disagreement on SPC.
Particular case: Mutual recognition in sequence related to
applications submitted under the BPD regime.
16.6 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
The case is related to an application for a national authorisation to the rMS and an application for mutual recognition to cMSs submitted before 1 September 2013.
The reference number (in the R4BP 3 this is the asset number) of the initiating application
for national authorisation can be found in the ‘General’ sub-tab in the ‘Case details’ page of the application for mutual recognition.
The application must contain the translation of the original authorisation in the rMS, SPC in
an editable format in a language accepted by the cMS and relevant documents for each
cMS as referred to in Annex II to "Notes for guidance to applicants for product
authorisation and mutual recognition" (CA-Sept12-Doc.6.2.a –Final.Rev2 -28/01/2013).
16.7 Workflow
BRC > EAA > MAA > VAL > EVL
16.8 Application requirements
The applicant has submitted an application for a national authorisation to the rMS
and an incomplete application for mutual recognition or an intention to submit an
application for mutual recognition after the first authorisation will have been
granted to cMSs before 1 September 2013;
The rMS grants the first authorisation after the 1 September 2013 without prior
transmission of its assessment report and SPC to the cMSs.
16.9 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task (see section 3.8) and complete the actions in the
“MSCA accept” page (Figure 17).
Fees under this step have already being paid at the time of the submission before
the BPR entered into operation.
Step 2: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
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18).
Validate the application within 30 days of the acceptance date in accordance with
Article 33(2) of the BPR and proceed with Step 5.
Step 3: Claim the “Evaluate & Decide” task.
Within 90 days of validating the application,
a. If you agree on the SPC, record your agreement in R4BP and by sending the
agreement through ad hoc communication to the applicant and, if applicable, to
the other cMSs (see section 3.8.2 on how to agree on the SPC).
In case a given cMS agrees on the SPC (and a positive assessment report), the
cMS completes the actions in the “Evaluate & Decide” page (Figure 20) and grants
the authorisation within 30 days of reaching agreement in conformity with the
agreed SPC and close the task by approving the application for the national
authorisation (see section 3.12). Before closing the task, upload the agreed SPC in
R4BP 3 (see section 3.8.2). Within 7 days after agreement, SPC should be
translated by applicant in all applicable languages (as requested by the cMS). The
finalised respective language versions of the SPC must be uploaded by the cMS
when approving the authorisation.
Make sure to assign the same expiry date as for the reference product. To find the
expiry date of the reference product go to the related cases tab of your case’s
details page and copy the reference number of the reference product (see point 8
of Figure 7). Search for the reference authorisation using this number.
b. If you consider that the BP assessed by the rMS does not meet the conditions laid
down in Article 19 of the BPR, send a detailed explanation of the points of
disagreement and the reasons for your position to the rMS, the other cMSs, the
applicant and, where applicable, the authorisation holder through ad hoc
communication. This shall be referred to the Coordination Group without delay (see
section 28).
c. If you refuse to grant the authorisation of the BP or want to adjust the terms and
conditions of the authorisation to be granted according to Article 37 of the BPR,
communicate to the applicant a detailed statement of the grounds for seeking a
derogation through ad hoc communication and seek to reach an agreement on the
proposed derogations.
You can also use the “resubmit task” and this will trigger the need for the applicant
to upload an IUCLID file and an SPC file.
16.10 Supporting documents
Template agreement/disagreement on SPC.
NA-BBP, NA-BBS National authorisation of the same biocidal product
17.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
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Authorisations can be sought in a Member State where a national authorisation according to
the BPD or the BPR has already been granted (authorised, NA-BBS) or an application for
such an authorisation has been submitted (pending, NA-BBP).
The new same biocidal product regulation (EU) 2016/1802, amending Implementing
Regulation (EU) No 414/2013, introduces the possibility to apply for authorisations in a
Member State whether an Union authorisation has already been granted (NA-BBS) or an
application for an Union authorisation has been submitted (NA-BBP).
The Competent Authority document (CA-March15-Doc.4.7) provides guidance on
applications for a same biocidal product of an individual product of a biocidal product family.
17.2 Workflow
BRC > MAA > VAL > EVL
17.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
17.4 Steps to be followed by the MSCA
17.4.1 NA-BBS National authorisation of same biocidal product (authorised)
Step 1: Claim the ‘MSCA accept’ task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 3: Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (3a) or not (3b).
a. If the fee has been paid accept and proceed with Step 4. The applicant will be
notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.12). The applicant
will be automatically notified (see section 3.12).
Step 4: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
18).
Validate the application within 30 days of the acceptance date. Check whether all information
described in Article 2 of Implementing Regulation (EU) No 414/2013, amended by
Regulation No 2016/1802, has been submitted and the proposed differences concern only
administrative changes (3a) or not (3b).
a. “Validate” and proceed with Step 5, or
b. “Reject application” (see section 3.12)
Step 5: Claim the “Evaluate & Decide” task (Figure 20) and complete the actions.
Within 60 days of validating the application, evaluate whether the biocidal product
72
is identical to the reference product, except for information on administrative
changes according to Implementing Regulation (EU) No 354/2013.
Close the task by approving or not approving the application for the product
authorisation (see section 3.12). Upload the final SPC with your decision.
Make sure to assign the same expiry date as for the reference product. To find the
expiry date of the reference product go to the related cases tab of your case’s details
page and copy the reference number of the reference product (see point 8 of Figure
7). Search for the reference authorisation using this number.
For the reference product a link is given to the same biocidal products under the
related assets/cases as appropriate.
The final SPC must not include confidential information, as it will be publicly
available.
Figure 34: Tracking the reference case or asset of a same biocidal product
17.4.2 National authorisation of same biocidal product (pending, NA-BBP)
For national authorisation of the same biocidal product (pending), the applicant submits an
application for product authorisation (the reference product) to the Member States, creating
the reference case, and simultaneously asks for the authorisation of one or more same
biocidal product(s). When the reference product is authorised the authorisation of the same
biocidal product(s) can be granted. Since the process is not automated the MSCA needs to
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follow the finalisation of the reference case and continue with this process once the
authorisation of the reference product is granted. Until finalisation of the reference product
authorisation, the authorisation of the same biocidal product cannot be granted.
Follow steps 1-3 of the same biocidal product (authorised) as appropriate. When a decision is
made with regard to the authorisation of the reference product proceed with step 4 and 5.
Please ensure that the decision on authorisation is sent within 60 days from the date of the
decision concerning the related reference product.
NA-ADC National authorisation - Administrative change on request
18.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
The possibility to transfer an authorisation to a new holder is listed as an
administrative change in the Changes Regulation (Annex, title 1, section 1,
item 3). However, this type of application must be made through the
procedure ‘transferring a national authorisation’ outlined in section 19.
The possibility to transform a frame formulation into a product family is also
listed as an administrative change in the Changes Regulation (Annex, title 1,
section 1, item 6). However, this type of application must be made through
the procedure ‘Merge of a product authorisation(s) in a family’ outlined
in section 20.
18.2 Workflow
BRC > MAA > EVL
18.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
18.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task (see section 3.8).
Step 2: Check whether there is a supporting document under the Documents tab which
indicates that you are the rMS and who the respective cMSs are. This information
or the related cases cannot be read from the case details. If the the applicant
made a group submission for change in mutually recognised assets, ECHA will
send an ad hoc communication (attach the supporting document) to all cMS listed
in the supporting document notifying them of the composition of rMS and cMS for
this submission.
Step 3: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Complete the actions in the “MSCA accept” page (Figure 17). Check whether the fee has been
paid within 30 days (a) or not (b).
74
a. If the fee has been paid, accept the application and proceed with Step 3. The
applicant will be notified accordingly.
b. If the relevant fee has not been paid, reject the application (see section 3.12) and
inform the other cMSs of the grounds for the rejection through ad hoc
communication in R4BP 3 (see section 3.10), using the template from the
supporting documents section below.
Step 4: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
Within 30 days following receipt of the notification (i. e. following the acceptance step)
a. If you agree, where relevant, amend the authorisation of the biocidal product in
conformity with the agreed change. Approve the application (see section 3.12)
and upload the amended SPC to R4BP 3. This needs to be done by each Member
State where the change applies.
b. if you disagree “do not approve” the application. This needs to be done by each
Member State where the change applies.
NA-TRS Transfer of a national authorisation
19.1 Introduction
Note that this process is an implementation of a notification of administrative change
concerning the transfer of an authorisation to a new holder related to NA assets referred by
the Changes Regulation, Annex, Title 1, Section 1, example 3. However, this type of
application must be made through this specific process type.
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
Please watch this YouTube video for a description of the process
19.2 Workflow
BRC > MAA > EVL
19.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
19.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 3: Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (3a) or not (3b).
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a. If the fee has been paid accept the application and proceed with Step
4. The applicant will be notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.12).
The applicant will be notified accordingly.
Step 4: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
Within 30 days following receipt of the notification (i. e. following the acceptance
step),
a. if you disagree with the transfer of the asset to a new Legal Entity established in
the EEA, select do not approve application in R4BP 3 (see section 3.12).
b. If you agree, where relevant, amend the authorisation of the biocidal product in
conformity with the information. Approve the application in R4BP 3 (see section
3.12) and upload the amended SPC to R4BP 3.
NA-MRG Merge of product authorisations in one product family
20.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
The NA-MRG case type in R4BP 3 serves for two purposes:
- The need to amend data in R4BP 3, where several assets should be merged as
part of a family or a single asset should cover different family members.
- The need to apply for a conversion from frame into a family; and
Note that this process is an implementation of a notification of administrative change
concerning the conversion of frame formulation established under the Biocidal Products
Directive 98/8/EC into product family listed as an administrative change in the Changes
Regulation (Annex, title 1, section 1, item 6). However, the creation of the biocidal product
family mast be made through the NA-MRG process type.
This process may also be used in situations where an applicant applied for a frame
formulation under the Biocidal Products Directive 98/8/EC but the authorisation for product
family was granted after 1 September 2013 and the system does not recognise the NA asset
as a product family. In such cases, which are not subject to fees pertaining to the
administrative changes, applicants are advised to contact the relevant MSCA.
20.2 Workflow
BRC > MAA > EVL
20.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
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20.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 3: Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (a) or not (b).
a. If the fee has been paid accept the application and proceed with Step 4. The
applicant will be notified accordingly.
b. If the fee has not been paid, reject the application (see section 3.12). The applicant
will be notified accordingly.
Step 4: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
Within 30 days following receipt of the notification (i. e. following the acceptance step)
a. Select approve the application if you agree that the assets included for merging
fall within the specifications of the frame formulation established under the
BPD. Each of the assets becomes a family member asset. Upload the amended
SPCs to R4BP 3. Following the approval, frame formulation is transformed into
a product family, the new product family asset will be visible in R4BP 3. If the
NA-MRG application was for a single asset, the product family will only contain
one member asset. The final SPCs for the family and the member assets are
stored in the correct family asset.
b. Select do not approve the application if you consider that the assets included
for merging do not fall within the specifications of the frame formulation
established under the BPD.
As a result of the conversion from frame to family via NA-MRG, a new
asset is created in R4BP 3. From version 3.8 the link between assets
joining a new family are kept even if a new asset number is given to the
newly formed family.
NA-MIC National authorisation - Minor change on request
21.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
21.2 Workflow
BRC > MAA > VAL > EVL
21.3 Application requirements
Please consult this manual of the Biocides Submission Manuals series for a description of
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the application requirements related to this process.
21.4 Steps to be followed by the MSCA
21.4.1 Steps to be followed by the rMS
Step 1: Claim the “MSCA accept” task (see section 3.8).
Step 2: Check the supporting document contained in the application for the full list of the
affected authorisations and respective rMS and cMSs.
Step 3: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 4: Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (a) or not (b).
a. If the fee has been paid, complete the task and move to step 5. The applicant will
be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application (see section
3.12) The applicant will be automatically notified. Inform the cMSs accordingly
through ad hoc communication (see section 3.10) using the template mentioned
in the supporting documents section below.
Step 5: Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
18).
Validate the application within 30 days of the acceptance date.
The validation shall not include an assessment of the quality or adequacy of the data or
justifications submitted.
a. If the application complies with Article 5 of the changes regulation, select validate
and complete and proceed with step 6. The applicant will be automatically notified.
b. If the application is deemed incomplete, request additional information from the
applicant using the ‘Request additional info’ functionality (see section 3.9). Set a
reasonable time limit not normally exceeding 45 days for resubmission.
i. Validate the application within 30 days of receipt of the additional
information. If the additional information submitted is sufficient, complete
the task and go to step 6. The applicant will be automatically notified.
ii. Reject the application if the applicant failed to submit the requested
information within the deadline. The applicant will be automatically notified.
Inform the cMSs via ad hoc communication (see section 3.10) using the
template mentioned in the supporting documents section below.
Step 6: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
Within 90 days following validation of the application, evaluate the application. The following
tasks related to R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID file where relevant.
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b. If additional information is needed to perform the evaluation, request additional
information from the applicant using the ‘Request additional info’ functionality (see
section 3.8) and set a reasonable time limit normally not exceeding 45 days for
resubmission. The request will stop the clock for this time limit. Reject the
application (see section 3.12) if the applicant fails to submit the requested
information within the deadline. The applicant will be automatically notified. Inform
the cMSs via ad hoc communication (see section 3.9) using the letter template
from the supporting documents section below.
c. Within 90 days of validating the application, draft the assessment report and send
it, where relevant, together, with the revised SPC to the cMSs and to the applicant
via ad hoc communication (see section 3.10).
Agreement by cMS and decision taking:
a. If, within 45 days following receipt of the updated assessment report and, where
relevant, the revised SPC, the cMSs have not expressed their disagreement, those
Member States shall be deemed to have agreed with the conclusions of the
assessment report and, where relevant, the revised SPC. If cMS expresses a
disagreement with the draft SPC, the rMS shall refer the detailed explanation of
the points of disagreement and the reasons for position received from the cMS to
the Coordination Group without delay (see section 28).
b. Following the 45 days, amend the authorisation of the biocidal product in
conformity with the agreed change within 30 days. Inform the applicant of the
agreement by approving the application in R4BP 3 (see section 3.12). The rMS
uploads the agreed SPC and updated assessment report in R4BP 3 together with
any agreed terms and conditions on the making available on the market or use of
the biocidal product.
21.4.2 Steps to be followed by the cMS
Step 1. Claim the “MSCA accept” task (see section 3.8).
Step 2. Check the supporting document contained in the application for the full list of the
affected authorisations and respective rMS and cMSs.
Step 3. Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 4. Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (a) or not (b).
a. If the fee has been paid, accept the application and move to step 5. The applicant
will be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application (see section
3.12). The applicant will be notified automatically. Inform the reference and where
relevant other cMSs accordingly through ad hoc communication (see section 3.10)
using the template mentioned in the supporting documents section below.
Step 5. Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
18).
Select “validate” or “reject” in line with the validation step outcome of the rMS.
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Step 6. Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
Within 90 days of validating an application, the rMS shall evaluate the application and draft
an assessment report and send it, where relevant, together with the SPC through ad hoc
communication to the cMSs and to the applicant.
a. Within 45 days following receipt of the updated assessment report and, where
relevant, the revised SPC, agree/disagree on the evaluation of the change(s).
Agree/disagree on the SPC by sending your position through ad hoc communication
to the rMS, the other cMSs and the applicant using the template from the
supporting documents sections below. If you disagree with the draft SPC, include
a detailed explanation of the points of disagreement. This shall be referred by the
rMS to the Coordination Group without delay (see section 28). If, within 45 days
following the receipt of the updated assessment, you have not expressed your
disagreement, you are deemed to have agreed with the conclusions of the
assessment report and, where relevant, the revised SPC.
b. In case a given cMS agrees with the draft SPC, the cMS completes the actions in
the “Evaluate & Decide” page (Figure 20) and amend the authorisation within 30
days of reaching the agreement in conformity with the agreed SPC and closes the
task by approving the application for the renewal of national authorisation (see
section 3.12).
c. If you refuse to grant the authorisation of the BP or want to adjust the terms and
conditions of the authorisation to be granted according to Article 37 of the BPR,
and on the grounds of Article 7 of Regulation (EU) No 492/2014, communicate a
detailed statement of the grounds for seeking a derogation to the applicant via ad
hoc communication and seek an agreement. If the agreement between the two is
not reached, the cMS informs COM via ad hoc communication who takes the final
decision.
The final SPC must not include confidential information, as it will be publicly
available.
21.5 Supporting documents
Template agreement to act as CA;
Template for agreement/disagreement on SPC.
NA-MAC National authorisation - Major change on request
22.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
22.2 Workflow
BRC > MAA > VAL > EVL
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22.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
22.4 Steps to be followed by the MSCA
22.4.1 Steps to be followed by the rMS
Step 1. Claim the “MSCA accept” task (see section 3.8).
Step 2. Check the supporting document contained in the application for the full list of
the affected authorisations and respective rMS and cMSs.
Step 3. Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 4. Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (a) or not (b).
a. If the fee has been paid, accept the application and move to step 5. The applicant
will be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application (see section
3.12). The applicant will be automatically notified. Inform the cMSs accordingly
through ad hoc communication (see section 3.10) using the letter template from
the supporting documents section below.
Step 5. Claim the ‘Validate’ task and complete the actions in the ‘Validation’ page (Figure
18).
Validate the application within 30 days.
The validation shall not include an assessment of the quality or adequacy of the data or
justifications submitted.
a. If the application complies with Article 5 of the changes regulation, select validate
and complete and proceed with step 6. The applicant will be automatically notified.
b. If the application is deemed incomplete, request additional information from the
applicant using the ‘Request additional info’ functionality (see section 3.9). Set a
reasonable period normally not exceeding 90 days for resubmission.
i. Validate the application within 30 days of receipt of the additional
information. If the additional information submitted is sufficient, select
validate, complete the task and go to step 6. The applicant will be
automatically notified.
ii. Reject the application if the applicant failed to submit the requested
information within the deadline. The applicant will be automatically notified.
Inform the other cMSs via ad hoc communication (see section 3.10) using
the template mentioned in the supporting documents section below.
c. Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (figure 20).
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Within 180 days following validation of the application, evaluate the application. The following
tasks related to R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID file where relevant.
b. If additional information is needed to perform the evaluation, request additional
information from the applicant using the ‘Request additional info’ functionality (see
section 3.8) and set a reasonable time limit normally not exceeding 90 days for
resubmission. The request will stop the clock for this time limit. Reject the
application (see section 3.12) if the applicant fails to submit the requested
information within the deadline. The applicant will be automatically notified. Inform
the cMSs via ad hoc communication (see section 3.9) using the letter template
from the supporting documents section below.
c. Within 180 days of validating the application, draft the assessment report and send
it, where relevant, together with the revised SPC to the cMSs and to the applicant
via ad hoc communication (see section 3.10)
Agreement by cMS and decision taking:
a. If within 90 days following receipt of the updated assessment report and, where
relevant, the revised SPC, the cMSs have not expressed their disagreement, those
Member States shall be deemed to have agreed with the conclusions of the
assessment report and, where relevant, the revised SPC. If cMS expresses a
disagreement with the draft SPC, the rMS shall refer the detailed explanation of
the points of disagreement and the reasons for position received from the cMS to
the Coordination Group without delay (see section 28).
b. Following the 90 days, amend the authorisation of the biocidal product in
conformity with the agreed change within 30 days. Inform the applicant of the
agreement by approving the application in R4BP 3 (see section 3.12). The rMS
uploads the agreed SPC and updated assessment report in R4BP 3 together with
any agreed terms and conditions on the making available on the market or use of
the biocidal product.
22.4.2 Steps to be followed by the cMS
Step 1. Claim the “MSCA accept” task (see section 3.8).
Step 2. Check the supporting document contained in the application for the full list of the
affected authorisations and respective rMS and cMSs.
Step 3. Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 4. Complete the actions in the “MSCA accept” page (Figure 17).
Check whether the fee has been paid within 30 days (a) or not (b).
a. If the fee has been paid, accept the application and move to step 5. The applicant
will be notified accordingly.
b. If the fee has not been paid within 30 days, reject the application (see section
3.12). The applicant will be notified automatically. Inform the reference and where
relevant other cMSs accordingly through ad hoc communication (see section 3.10)
using the template from the supporting documents section below.
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Step 5. Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
Within 180 days following validation of the application, the rMS shall evaluate the application
and draft the assessment report and send it, where relevant, together with the SPC through
ad hoc communication to the cMSs and to the applicant.
a. Within 90 days following receipt of the updated assessment report and, where
relevant, the revised SPC, agree/disagree on the evaluation of the change(s).
Agree/disagree on the SPC by sending your position through ad hoc
communication to the rMS, the other cMSs and the applicant using the template
from the supporting documents sections below. If you disagree with the draft SPC,
include a detailed explanation of the points of disagreement. This shall be referred
by the rMS to the Coordination Group without delay (see section 28). If, within 90
days following the receipt of the updated assessment, you have not expressed
your disagreement, you are deemed to have agreed with the conclusions of the
assessment report and, where relevant, the revised SPC.
b. In case a given cMS agrees with the draft SPC, the cMS completes the actions in
the “Evaluate & Decide” page (Figure 20) and amend the authorisation within 30
days of reaching the agreement in conformity with the agreed SPC and closes the
task by approving the application for the renewal of national authorisation (see
section 3.12).
c. If you refuse to grant the authorisation of the BP or want to adjust the terms and
conditions of the authorisation to be granted according to Article 37 of the BPR,
and on the grounds of Article 7 of Regulation (EU) No 492/2014, communicate a
detailed statement of the grounds for seeking a derogation to the applicant via ad
hoc communication and seek an agreement. If the agreement between the two is
not reached, the cMS informs COM via ad hoc communication who takes the final
decision.
22.5 Supporting documents
Template agreement to act as CA;
Template agreement/disagreement on SPC.
NA-AAT Amendment of National authorisation
23.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
Article 48 of the BPR describes the possibility for the MSCA (or COM for Union authorisation-
described in a different process – future UA-AAT) to cancel or amend an existing national
authorisation. This decision is triggered by one of the situations described in section 23.3.
Where the competent authority intends to amend an authorisation, it shall inform the
authorisation holder and give it the opportunity to submit comments or additional
information within a specified time limit. The evaluating competent authority shall take due
account of those comments when finalising its decision.
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Where the competent authority cancels or amends an authorisation it shall immediately
notify the authorisation holder, the competent authorities of the concerned Member States
and the Commission.
Competent authorities that have issued authorisations under the mutual recognition
procedure for biocidal products for which the authorisation has been cancelled or amended
shall, within 120 days of the notification, cancel or amend the authorisations and shall notify
the Commission accordingly.
In the case of disagreement between competent authorities of certain Member States
concerning national authorisations subject to mutual recognition the procedures laid down
in Articles 35 and 36 of the BPR shall apply.
In case the amendment concerns a product family it must be started from the reference
asset and new SPCs must be provided for all the component of the family.
In case additional data is needed from the applicant, you can use the “New
communication” functionality. This functionality cannot be used to request for
a IUCLID dossier. For a NA-AAT case type, R4BP 3 will only consider the final
SPC uploaded by authorities and any supporting documentation you include in
this case.
23.2 Workflow
MSCA initiated > EVL
23.3 Application requirements
An existing national authorisation needs to be amended based on one of the following
situations:
the conditions referred to in Article 19 are not (longer) fully satisfied; or
the authorisation was granted on the basis of false or misleading information; or
the authorisation holder has failed to comply with its obligations under the
authorisation or under the BPR.
23.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be amended, click on “Create new case” (as shown in Figure
11) and select the NA-AAT case type from the drop-down menu. This will create a
task (with a case number) that you can find in the task tab.
Step 2: Claim the task “Evaluate & Decide“.
a. Inform the AH giving the opportunity to comment in 30 days using ad hoc
communication (see section 3.10).
b. Select the option that reflects your decision on the cancellation of the
authorisation (Approve or Do not approve) under Task details in R4BP 3 (see
section 3.12). Complete the “Evaluate & Decide” task (Figure 20).
Step 3: Notify the authorisation holder (the applicant, if different than the AH), the
Commission and other MSCA (cMS) of the decision taken using ad hoc
communication (see section 3.10).
Step 4: In case of mutually recognised authorisations, each cMS shall amend the
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authorisation within 120 days of the notification described in step 3 using the same
R4BP 3 process (NA-AAT).
Step 5: In case of disagreement between CA(s) on the amendment of mutually recognised
authorisations, follow the procedure described in section 28.2.
NA-CAT Cancellation of national authorisation
24.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
Article 48 of the BPR describes the possibility for the MSCA (or COM for Union authorisation-
described in a different process – future UA-AAT) to cancel or amend an existing national
authorisation. This decision is triggered by one of the situations described in section 21.3.
In case cancellation concerns a member of a family it must be started from the asset of that
member of the family.
24.2 Workflow
MSCA initiated > EVL
24.3 Application requirements
An existing national authorisation needs to be cancelled based on one of the following
considerations:
the conditions referred to in Article 19 are not (longer) satisfied; or
the authorisation was granted on the basis of false or misleading information; or
the authorisation holder has failed to comply with its obligations under the
authorisation or under the BPR.
24.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be cancelled, click on “Create new case” (as shown in Figure
11) and and select the NA-CAT case type from the drop-down menu. This will
create a task (with a case number) that you can find in the task tab.
Step 2: Claim the task “Evaluate & Decide“.
a. Inform the authorisation holder giving the opportunity to comment in 30 days
using ad hoc communication (see section 3.10)
b. Select the option that reflects your decision on the cancellation of the
authorisation (Approve or Do not approve) under Task details in R4BP 3 (see
section 3.12). Complete the “Evaluate & Decide” task (Figure 20).
Step 3. Notify the authorisation holder (the applicant, if different than the authorisation
holder), the Commission and other MSCA (cMS) of the decision taken using ad hoc
communication (see section 3.10).
Step 4. In case of mutually recognised authorisations, each cMS shall cancel the
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authorisation within 120 days of the notification described in the previous step
using the same R4BP 3 process (NA-CAT).
Step 5. In case of disagreement between CA(s) on the amendment of mutually recognised
authorisations, follow the procedure described in section 28.2.
NA-CCL National authorisation cancellation on request
25.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
25.2 Workflow
BRC > EVL
25.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
25.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task (Figure 20).
Step 2: Complete the actions in the “Evaluate & Decide” page:
Approve the application if the (re)submitted information is complete and correct
(see section 3.12) and set the cancellation date.
Please note that the reject and the request additional information options
are only present in this task since R4BP 3 uses the Evaluate & Decide task
to finalise this process. Thes two options should not be used since the BPR
requires the MSCAs to accept the request in any case. Furthermore, no
time period is given in the BPR to finalise this task.
ET-NOT Notification for experiment or test
26.1 Introduction
Please consult the Research and Development chapter of the BPR Practical Guide for a
description of the regulatory requirements and the related process.
26.1 Workflow
BRC > EVL
26.2 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
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26.3 Steps to be followed by the MSCA
Step 1. Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
a. If you consider that the application is incomplete, inform the applicant of the
additional information that is required. Through ‘request additional information’
(see section 3.9) a resubmission task item for the applicant is created. Set a
reasonable period for the submission of the additional information.
b. If you are satisfied that the application meets the information requirements laid
down in Article 56(2) and authorise/restrict (by selecting approve) or ban (by
selecting do not approve) the tests or experiments in line with the criteria in Article
56(3) within 45 days of the “Evaluation started” date.
c. If the CA issues no opinion within 45 days the applicant can start the test or
experiment.
NA-NPF Notification of product in product family for national authorisation
27.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
27.2 Workflow
BRC > EVL
27.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
27.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task.
Step 2: Complete the actions in the “Evaluate & Decide” page (Figure 20)
a. Check whether the notified product belongs to the related biocidal product family
according to the national authorisation.
b. Request additional information through the ‘request additional information’ item
(see section 3.9); a resubmission task item for the applicant is created. Set a
reasonable period for the submission of the additional information
c. If the submitted information is complete and correct, approve the notification (see
section 3.12); a new asset will be created with the authorisation number having
the suffix subsequent to the last authorised family member. All the family members
with the appropriate authorisation numbers (including the suffix) are shown under
the ‘family information’ of the related biocidal product family’s asset. Ensure you
include the correct authorisation number having the appropriate suffix in the
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decision.
d. Please note that an updated SPC needs to be uploaded before finalising the task
as specified in Figure 21.
e. Select “Do not approve the notification” if the conditions for adding the product
into the product family are not met.
Settlement of disagreements (n/a)
28.1 Pre-conditions
The applicant has submitted
o an application for mutual recognition (either in parallel or in sequence) or
o a notification for placing on the market (simplified authorisation) according to
Article 27(2) or
o an application/notification for minor/major change in relation to national
authorisation (subject to mutual recognition)/simplified authorisations
o an application for renewal of authorisations subject to mutual recognition
through R4BP 3.
According to Article 35(2) of the BPR, only concerned MSs are allowed to start the
process.
28.2 Steps to be followed by the MSCA
As mentioned in section 3.8 this process is not a separate one in R4BP 3 but is relevant for
the finalisation of the above mentioned processes. Therefore, this process is included in the
present manual. The working procedures of the Coordination Group describe how this
process is designed in detail.
The concerned Member State (cMS) shall send the detailed explanation of the points of
disagreement and the reasons for its position at the same time to the reference Member
State (rMS), the other cMSs, the Coordination Group (CG) secretariat, the applicant, and
where applicable, to the authorisation holder.
Before concluding that a formal procedure should be launched, Member States should have
an informal exchange between themselves, keeping ECHA informed.
For sending the disagreement, use the ad hoc communication in R4BP 3 (see section 3.10).
You might select ‘Comments’ in the ‘Topic’ as well as in the ‘Doc. Type’ fields. For the
‘Subject’ field please fill in ‘Referral to CG’. If you decide to also record the informal exchange
in R4BP 3, please use ‘Information to CG on Mutual Recognition issues’ in the ‘Subject’ field.
When sending the ad hoc communication to the rMS, please select the box ‘Reply required’.
In this way, a task item will be created for the rMS and by answering to that, the
communication /agreement can be recorded in R4BP 3.
If an agreement is reached in CG, the rMSs and/or cMSs need to implement the agreement.
If no agreement is reached within the 60-day period, the rMS submits the points of
disagreement to the Commission.
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NE-NOT Notification of an unexpected or adverse effect
national authorisation
29.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
29.2 Workflow
BRC > EVL
29.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
29.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
a. If the application does not contain sufficient information as laid down in Article 47,
to assess whether authorisation needs to be amended or cancelled, request
additional information from the applicant using the ‘Request additional info’
functionality (further information in sections 3.9). Set a reasonable time limit for
the submission of the additional information.
b. Notify competent authorities of other Member States using the ad hoc
communication in R4BP 3 (see section 3.10).
c. Check whether the notified unexpected or adverse effect affects the conditions
under which the national authorisation was granted. Take a decision on whether
the authorisation needs to be amended or cancelled. Close the task selecting one
of the relevant options described in section 3.12.
Step 2. Cancel or amend the respective authorisation using NA-AAT or NA-CAT processes.
In case of amendment upload the final PAR and SPC to R4BP 3.
PP-APP Parallel Trade
30.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
30.2 Workflow
BRC > MAA > EVL
30.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
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30.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 3: Complete the actions in the “MSCA accept“(Figure 17).
Check in your national invoicing system whether the fee has been paid within 30
days (3a) or not (3b).
a. Complete and proceed with Step 4.
b. Reject the application via R4BP 3.
Step 4: Claim the “Evaluate & Decide” task and complete the actions in the “Evaluate &
Decide” page (Figure 20).
Evaluate whether the biocidal product fulfils the requirements according to Article
53(3), i.e. is identical to the reference product. Additional information may be
requested via ad hoc communication (see section 3.10) from the MSCA of the MSO
(or the applicant). The MSCA of the MSO has 30 days to provide the requested
information.
Approve or reject the parallel trade permit application via R4BP 3 within 60 days
from the date the fee has been received.
PP-AAT Amendment of parallel trade permit
31.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
If a parallel trade permit needs to be amended, the interested MSCA needs to initiate a task
under the case type PP-AAT.
31.2 Workflow
MSCA initiated > EVL
31.3 Application requirements
Conditions to amend a parallel trade permit need to be met.
31.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be amended and select the PP-AAT action. This will create a
task (with a case number) that you can find in the task tab. Claim the task
“Evaluate & Decide“.
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Step 2: Inform the permit holder giving the opportunity to comment in 30 days using ad
hoc communication (see section 3.10)
Step 3: Decide on the amendment of the permit under Task details in R4BP 3 (see section
3.12).
Step 4: Complete the “Evaluate & Decide” task (Figure 20) by selecting “Approve” or “Do
not approve”.
PP-CAT Cancellation of parallel trade permit
32.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
If a parallel trade permit needs to be cancelled, the interested MSCA needs to initiate a task
under the case type PP-CAT.
32.2 Workflow
MSCA initiated > EVL
32.3 Application requirements
Conditions to cancel a parallel trade permit need to be met.
32.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be cancelled and select the PP-CAT action. This will create a
task (with a case number) that you can find in the task tab. Claim the task
“Evaluate & Decide“.
Step 2: Inform the permit holder giving the opportunity to comment in 30 days using ad
hoc communication (see section 3.10)
Step 3: Decide on the withdrawal of the parallel trade permit under Task details in R4BP
3 (see section 3.12).
Step 4: Complete the “Evaluate & Decide” task (Figure 20) by selecting “Approve” or “Do
not approve”.
SA-APP National authorisation – simplified procedure
33.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
33.2 Workflow
BRC > MAA > EVL
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33.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
33.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11).
Step 3: Complete the actions in the “MSCA accept” page (Figure 17).
Check in your national invoicing system whether the fee has been paid within 30
days (3a) or not (3b).
a. If the fee has been paid, accept and proceed with Step 4.
b. If the fee has not been paid, reject the application (see section 3.12).
Step 4: Claim the ‘Evaluate & Decide’ task and complete the actions in the ‘Evaluate &
Decide’ page (Figure 20).
a. If you are satisfied that the product meets the conditions laid down in Article 25,
authorise the product within 90 days of the acceptance date. Grant the product
authorisation using the ‘approve application’ function (see section 3.12).
b. If you consider that the application is incomplete, inform the applicant of the
additional information that is required. Through ‘request additional information’
(see section 3.9) a resubmission task item for the applicant is created to submit a
new IUCLID dossier. Through ad hoc communication with request for a reply (see
section 3.10), a task is created for which other files than IUCLID dossiers can be
sent via R4BP 3.
c. Set a reasonable period for the submission of the additional information which
should normally not exceed 90 days. Authorise the product within 90 days of
receipt.
Reject the application if the applicant fails to submit the requested information by
the deadline (see section 3.12).
SA-BBS Simplified authorisation of the same biocidal
product (authorised)
34.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
34.2 Workflow
BRC > MAA > VAL > EVL
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34.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
34.4 Steps to be followed by the MSCA
Please follow the same steps of section 17.4.1.
SA-BBP Simplified authorisation of the same biocidal product (pending)
35.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
35.2 Workflow
BRC > MAA > VAL > EVL
35.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
35.4 Steps to be followed by the MSCA
In the simplified authorisation of the same biocidal product (pending) procedure, an
applicant submitted an application for a simplified product authorisation (the reference
product) to the Member States, creating the reference case. Other application(s) are
submitted for the simplified authorisation of one or more same biocidal product(s). When
the reference product is authorised the simplified authorisation of the same biocidal
product(s) can be granted. Since the process is not automated the MSCA needs to follow
the finalisation of the reference case and continue with the (pending) process as soon as the
authorisation of the reference product is granted. Until finalisation of the reference product
authorisation, the authorisation of the same biocidal product cannot be granted.
Please follow steps 1-3 of section 17.4.1. When a decision is made with regard to the
authorisation of the reference product, you can proceed with step 4 and 5. Please ensure
that the decision on authorisation is sent within 60 days from the date of the decision
concerning the related reference product.
SA-CAT Cancellation of simplified authorisation
36.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
In case cancellation concerns a member of a family it must be started from the asset of that
member of the family.
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36.2 Workflow
MSCA initiated > EVL
36.3 Application requirements
An existing simplified authorisation needs to be cancelled based on one of the following
considerations:
the conditions referred to in Article 25 are not (longer) satisfied; or
the authorisation was granted on the basis of false or misleading information; or
the authorisation holder has failed to comply with its obligations under the
authorisation or under the BPR.
36.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be cancelled and select the SA-CAT action. This will create a
task (with a case number) that you can find in the task tab. Claim the task
“Evaluate & Decide“.
Step 2: Inform the simplified authorisation holder giving the opportunity to comment in
30 days using ad hoc communication (see section 3.10)
Step 3: Decide on the cancellation of the authorisation under Task details in R4BP 3 (see
section 3.12).
Step 4: Complete the “Evaluate & Decide” task (Figure 20) by selecting “Approve” or “Do
not approve”.
Step 5: Notify the simplified authorisation holder, the Commission and all other MSCAs of
the decision taken using ad hoc communication (see section 3.10)
Step 6: In case notifications in other MSCA need to be cancelled, each cCA must contact
the ECHA Helpdesk.
SA-AAT Amendment of simplified authorisation
37.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
In case the amendment concerns a product family it must be started from the reference
asset and new SPCs must be provided for all the component of the family.
37.2 Workflow
MSCA initiated > EVL
37.3 Application requirements
An existing simplified authorisation needs to be amended based on one of the following
situations:
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the conditions referred to in Article 25 are no longer fully satisfied; or
the authorisation was granted on the basis of false or misleading information; or
the authorisation holder has failed to comply with its obligations under the
authorisation or under the BPR.
37.4 Steps to be followed by the MSCA
Step 1: Choose the asset to be amended and select the SA-AAT action. This will create a
task (with a case number) that you can find in the task tab. Claim the task
“Evaluate & Decide“.
Step 2: Inform the simplified authorisation holder giving the opportunity to comment in
30 days using ad hoc communication (see section 3.10)
Step 3: Decide on the amendment of the authorisation under Task details in R4BP 3 (see
section 3.12).
Step 4: Complete the “Evaluate & Decide” task (Figure 20) by selecting “Approve” or “Do
not approve”.
Step 5: Notify the simplified authorisation holder, the Commission and all other MSCAs of
the decision taken using ad hoc communication (see section 3.10)
Step 6: In case notifications in other MSCAs need to be amended, the applicant should be
required to submit new notifications through SN-NOT.
SA-ADC Simplified authorisation administrative change on request
38.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
38.2 Workflow
BRC > EVL
38.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
38.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task.
Step 2: Complete the actions in the “Evaluate & Decide” page (Figure 20) by checking
whether the submitted information is complete and correct and amend the
authorisation of the biocidal product in conformity with the agreed change.
Step 3: Approve the application (see section 3.12) and upload the amended SPC to R4BP
3.
Step 4: Reject the notification if the submitted information is incomplete or/and incorrect
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(see section 3.12).
SA-TRS Transfer of a simplified authorisation
39.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
Please watch this YouTube video for a description of the process.
39.2 Workflow
BRC > EVL
39.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
39.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task.
Step 2: Complete the actions in the “Evaluate & Decide” page (Figure 20) by checking
whether the submitted information is complete and correct and amend the
authorisation of the biocidal product in conformity with the agreed change.
Step 3: Approve the application (see section 3.12) and upload the amended SPC to R4BP
3.
Step 4: Reject the transfer if the submitted information is incomplete or/and incorrect
(see section 3.12).
SA-MIC Simplified authorisation minor change on request
40.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
40.2 Workflow
BRC > MAA > EVL
40.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
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40.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Within 30 days following receipt of the notification, if you disagree with the
change or the relevant fee has not been paid, reject the case in R4BP 3 (see
section 3.12) and inform the applicant on the grounds for the rejection. Inform
the other cMSs also on the grounds for the rejection through ad hoc
communication in R4BP 3 (see section 3.10), using the template mentioned in
the supporting documents section below.
Step 2: Complete the actions in the “MSCA accept” page (Figure 17).
Step 3: Claim the “Evaluate & Decide” task (Figure 20).
Step 4: Complete the actions in the “Evaluate & Decide” page (Figure 20) by amending
the simplify authorisation of the biocidal product in conformity with the agreed
change. Approve the case (see section 3.12) and upload the amended SPC to
R4BP 3.
Step 5: Notify other MSCA (cMS) of the decision taken using ad hoc communication (see
section 3.10).
Step 6: In case notifications in other MSCAs need to be amended, the applicant should
be required to submit new notifications through SN-NOT.
40.5 Supporting documents
Template rejection of an application.
SA-MAC Simplified authorisation major change on request
41.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
41.2 Workflow
BRC > MAA > EVL
41.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
41.4 Steps to be followed by the MSCA
Step 1: Claim the “MSCA accept” task.
Within 30 days following receipt of the notification, if you disagree with the
change or the relevant fee has not been paid, reject the case in R4BP 3 (see
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section 3.12) and inform the applicant on the grounds for the rejection. Inform
the other cMSs also on the grounds for the rejection through ad hoc
communication in R4BP 3 (see section 3.10), using the template mentioned in
the supporting documents section below.
Step 2: Complete the actions in the “MSCA accept” page (Figure 17).
Step 3: Claim the “Evaluate & Decide” task.
Step 4: Complete the actions in the “Evaluate & Decide” page (Figure 20) by amending
the authorisation of the biocidal product in conformity with the agreed change.
Approve the case (see section 3.12) and upload the amended SPC to R4BP 3.
Step 5: Notify other MSCA (cMS) of the decision taken using ad hoc communication (see
section 3.10).
Step 6: In case notifications in other MSCAs need to be amended, the applicant should
be required to submit new notifications through SN-NOT.
SA-NPF Notification of product in product family for simplified authorisation
42.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
42.2 Workflow
BRC > EVL
42.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
42.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task.
Step 2: If the submitted information is correct, go to Step 3 or request further information
otherwise (see section 3.9).
Step 3: Accept the notification or reject it if the submitted information is still incorrect or
incomplete (see section 3.12).
SE-NOT Notification of unexpected or adverse effect for SA
43.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
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43.2 Workflow
BRC > EVL
43.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
43.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task (Figure 20).
Step 2: If the submitted information is correct, go to Step 3 or request further information
otherwise (see section 3.9).
Step 3: Accept the notification or reject it if the submitted information is still incorrect or
incomplete (see section 3.12).
SN-NOT Notification for placing on the market - simplified procedure
44.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
44.2 Workflow
BRC > EVL
44.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
44.4 Steps to be followed by the MSCA
Step 1: Claim the “Evaluate & Decide” task (Figure 20).
Step 2: If the submitted information is correct, go to Step 3 or request further information
otherwise (see section 3.9).
Step 3: Accept the notification or reject it if the submitted information is still incorrect or
incomplete (see section 3.12).
Step 4: If a MSCA (other than the eCA) considers that the biocidal product has not been
notified, labelled or does not meet the requirements of Article 25, it may refer the
matter to the Coordination Group without delay (see section 28).
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UA-APP Union authorisation
45.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
45.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
45.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
45.4 Steps to be followed by the MSCA
The eCA needs to claim the task during the authorisation process and can request further
information through the task item.
Step 1: Claim the ‘Validation’ task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11). If the fee is not paid within 30 days, reject the application. Inform ECHA of
the rejection and ask to close the case via ad hoc communication in R4BP 3 (see
section 3.10). Once the application is closed the applicant will be automatically
notified.
Step 3: Complete the actions in the ‘Validation’ page (Figure 18).
Validate the application within 30 days after receiving the task from ECHA
according to BPR Article 43(3). The validation includes verifying whether the
information requirements for biocidal products are fulfilled.
The validation shall not include an assessment of the quality or adequacy of the
data or justifications submitted.
a. If the information requirements are fulfilled, complete the validation task and
follow on with Step 4.
b. If the information requirements described above are not fulfilled, inform the
applicant what additional information is required for validating the application. Use
‘Request additional information’ (see section 3.9), if you require a new IUCLID
dossier set a reasonable time limit for the submission of the additional information.
This shall normally not exceed 90 days.
c. Validate the application within 30 days of receipt of the additional information in
R4BP 3. Reject the application if the applicant fails to submit the requested
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information within the deadline or the information requirements remain
incomplete. The applicant (case owner) will be automatically notified. Inform ECHA
of the rejection through ad hoc communication in R4BP 3 (see section 3.10). Part
of the fees paid by the applicant to the eCA may need to be reimbursed.
Step 4: Claim the “Evaluate” task and complete the actions in the “Evaluation” page
(Figure 19).
Evaluate the application within 365 days (BPR Article 44(1)). The following tasks
related to R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID file where relevant.
b. Consult with ECHA via ad hoc communication if additional information is required.
For ‘stop the clock’ requests request additional information as described in Step 3.
c. Inform ECHA via ad hoc communication (see section 3.10) as soon as possible on
issues identified that may need to be discussed at a working group meeting already
before submitting the PAR and the dossier enters the peer review phase.
d. Perform a confidentiality claims check by evaluating the justifications submitted by
the applicant (this step is not yet agreed by all the MSCA).
Step 5: ECHA suggests that no later than 60 days before the end of the 365-day evaluation
period the eCA sends the PAR and the draft SPC to the applicant for a 30-day
commenting period. Reply to the applicant’s comments and adapt the PAR and draft
SPC accordingly if necessary.
Send the results of the evaluation in the form of a PAR together with an annotated
IUCLID dossier. The eCA also submits the draft SPC. According to the “Working
procedures for evaluating an application for Union authorisation” Table 1, the
submission is done via ad-hoc communication in R4BP 3.
45.5 Supporting documents
Template agreement to act as CA.
UA-APP (WA) Provisional Union authorisation
46.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
46.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
46.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
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46.4 Steps to be followed by the MSCA
The eCA needs to claim the task during the authorisation process and can request further
information through the task item.
Step 1: Claim the ‘Validation’ task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11). If the fee is not paid within 30 days, reject the application. Inform ECHA of
the rejection and ask to close the case via ad hoc communication in R4BP 3 (see
section 3.10). Once the application is closed the applicant will be automatically
notified.
Step 3: Complete the actions in the ‘Validation’ page (Figure 18).
Validate the application within 30 days after receiving the task from ECHA according to BPR
Article 43(3). The validation includes verifying whether the information requirements for
biocidal products are fulfilled and that the evaluating competent authority has given a
positive opinion in the CAR (please check the CAR uploaded in the R4BP 3 or CIRCA BC page
under the new active folders)
The validation shall not include an assessment of the quality or adequacy of the data or
justifications submitted.
a. If the information requirements are fulfilled, complete the validation task and
follow on with Step 4.
b. If the information requirements described above are not fulfilled, inform the
applicant what additional information is required for validating the application. Use
‘Request additional information’ (see section 3.9), if you require a new IUCLID
dossier Set a reasonable time limit for the submission of the additional information.
This shall normally not exceed 90 days.
c. Validate the application within 30 days of receipt of the additional information in
R4BP 3. Reject the application if the applicant fails to submit the requested
information within the deadline or the information requirements remain
incomplete. The applicant (case owner) will be automatically notified. Inform ECHA
of the rejection through ad hoc communication in R4BP 3 (see section 3.10). Part
of the fees paid by the applicant to the eCA may need to be reimbursed.
Step 4: Claim the “Evaluate” task and complete the actions in the “Evaluation” page (Figure
19).
Evaluate the application within 365 days (BPR Article 44(1)). The following tasks
related to R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID file where relevant.
b. Consult with ECHA via ad hoc communication if additional information is required.
For ‘stop the clock’ requests request additional information as described in Step 3.
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c. Inform ECHA via ad hoc communication (see section 3.10) as soon as possible on
issues identified that may need to be discussed at a working group meeting already
before submitting the PAR and the dossier enters the peer review phase.
d. Perform a confidentiality claims check by evaluating the justifications submitted by
the applicant (this step is not yet agreed by all the MSCA).
Step 5: ECHA suggests that no later than 60 days before the end of the 365-day evaluation
period the eCA sends the PAR and the draft SPC to the applicant for a 30-day
commenting period. Reply to the applicant’s comments and adapt the PAR and
draft SPC accordingly if necessary.
Send the results of the evaluation in the form of a PAR together with an annotated
IUCLID dossier. The eCA also submits the draft SPC. According to the “Working
procedures for evaluating an application for Union authorisation” Table 1, the
submission is done via ad-hoc communication in R4BP 3.
46.5 Supporting documents
Template agreement to act as CA.
UA-MAC Union authorisation major change on request
47.1 Introduction
Please consult this chapter of the BPR Practical Guide for a description of the regulatory
requirements and the related process.
47.2 Workflow
BRC > EAA > VAL > MEV > OPN > DEC
47.3 Application requirements
Please consult this Biocides Submission Manual for a description of the application
requirements related to this process.
47.4 Steps to be followed by the MSCA
Step 1: Claim the ‘Validation’ task.
Step 2: Issue an invoice according to Article 80(2) of the BPR and send it to the applicant
via the ’Case details’ – ‘Financial management’ sub-tab in R4BP 3 (see section
3.11) within 15 days after receiving the task from ECHA. If the fee is not paid
within 30 days, reject the application. Inform ECHA of the rejection and ask to
close the case via ad hoc communication in R4BP 3 (see section 3.10). Once the
application is closed the applicant will be automatically notified.
Step 3: Complete the actions in the ‘Validation’ page (Figure 18).
Validate the application within 30 days after receiving the task from ECHA
according to BPR Article 43(3). The validation includes verifying whether the
information requirements for biocidal products are fulfilled.
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The validation shall not include an assessment of the quality or adequacy of the
data or justifications submitted.
a. If the information requirements are fulfilled (Art 5 of the Regulation (EU)
354/2013), complete the validation task and follow on with Step 4.
b. If the information requirements described above are not fulfilled, request additional
information from the applicant using the ‘Request additional information’
functionality (see section 3.9). Set a reasonable time limit for the submission of
the additional information. This shall normally not exceed 90 days.
i. Validate the application within 30 days of receipt of the additional
information. If the additional information submitted is sufficient, select
validate, complete the task and go to step 4. The applicant will be
automatically notified.
ii. Reject the application if the applicant failed to submit the requested
information within the deadline or the information requirements remain
incomplete. The applicant (case owner) will be automatically notified.
Inform the other cMSs via ad hoc communication (see section 3.10) using
the template mentioned in the supporting documents section below.
Step 4: Claim the “Evaluate” task and complete the actions in the “Evaluation” page
(Figure 19).
Evaluate the application within 180 days according with Article 13(4) of Regulation
354/2013). Before sending the PAR and conclusions to ECHA, the following tasks
related to R4BP 3 can be considered during the evaluation:
a. Annotate IUCLID file where relevant.
b. Request additional information from the applicant if necessary to carry out the
evaluation using the ‘Request additional information’ functionality (see section
3.9). Set a reasonable period for the submission of the additional information,
which should normally not exceed 90 days in total. Reject the application (see
section 3.12) if the applicant fails to submit the requested information within the
deadline. The applicant will be automatically notified. Inform the cMSs via ad-hoc
communication.
c. Draft a product assessment report (PAR) summarising the conclusions of the
assessment and the reasons for authorising or refusing to grant the authorisation.
Amend if necessary the draft SPC generated by the applicant. Send an electronic
copy of the PAR and the SPC to the applicant through ad hoc communication (see
section 3.10) and provide the opportunity to submit comments within 30 days
(request reply).
d. Finalise the assessment taking into account the comments provided by the
applicant.
e. Perform a confidentiality claims check by evaluating the justifications submitted by
the applicant.
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f. Complete the actions in the “Evaluate & Decide” page by by approving or not
approving the application and at the same time upload the final PAR and SPC to
R4BP 3.
47.5 Supporting documents
Template agreement to act as CA.
Annex I CA agreement v.2
Agreement to act as the Competent Authority under
Regulation (EU) No 528/2012, Regulation (EU) No
354/2013 or Regulation (EU) No 492/2014
The undersigned Competent Authority (CA) hereby agrees to serve as the Competent
Authority in the following evaluation under Regulation (EU) No 528/2012 concerning the
making available on the market and use of biocidal products (Biocidal Products Regulation)
or Regulation (EU) No 354/2013 on changes of biocidal products authorised in accordance
with Regulation (EU) No 528/2012 (Change Regulation), Regulation (EU) No 492/2014
concerning renewal of authorisations of biocidal products subject to mutual recognition*:
Application type (please specify application type):
Applicant/Company UUID:
Signed on behalf of the CA:
Date:
Name:
* Delete as appropriate
How to run BPR processes with R4BP 3 in Member State
competent authorities Release date: October 2016
105
Title:
CA and contact information:
Annex II SPC agreement
Agreement/Disagreement on Summary of biocidal
Product Characteristics (SPC) under Regulation
(EU) No 528/2012, Regulation (EU) No 354/2013
or under Regulation (EU) No 492/2014
The undersigned Competent Authority (CA) hereby states agreement or disagreement to the
Summary of the biocidal Product Characteristics (SPC) of the following evaluation under Regulation
(EU) No 528/2012 concerning the making available on the market and use of biocidal products
(Biocidal Products Regulation), under Regulation (EU) No 354/2013 on changes of biocidal
products authorised in accordance with Regulation (EU) No 528/2012 (Change Regulation) or
under Regulation (EU) No 492/2014 as regards the rules for the renewal of authorisations of
biocidal products subject to mutual recognition.
Application type:
Applicant:
Case number:
Reference Member State:
Agree Disagree
Summary of the rationale for disagreement:
Signed on behalf of the CA:
Date:
Name:
Title:
CA and contact information:
EUROPEAN CHEMICALS AGENCY
ANNANKATU 18, P.O. BOX 400,
FI-00121 HELSINKI, FINLAND
ECHA.EUROPA.EU