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Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.ages.at
Current situation - Article 43
Christian ProhaskaAustrian Agency for Health and Food Safety (AGES)ECPA-ECCA Conference 2014, Brussels
www.ages.at 2
Overview
• 1 - General considerations
• 2 – Current situation
• 3 - Outlook
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1 – General considerations
Re-newal of products
Source: MeBeFree
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1 – General considerations
Renewal according to Article 43 of 1107/2009:
- Application – 3 months after Commission´s decision (entry into force) of renewal of the active- Compliance check (step I) and assessment (step II) by zRMS – 6 months (-> zonal RMS`s RR)- Decision on renewal of authorisation by all concerned MS in the zone - 3 months
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1 – General considerations
According to the Regulation (Article 43.3), the RMS "co-ordinates" step 1 and 2 within the corresponding zone
- Short timelines (3 months for preparing a complete dossier, 6 months for evaluation incl.
commenting)
- High number of products and products with >1 active
- New data requirements for products
- New endpoints for the active
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2 – Current situation
Source: Benthehack
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2 – Current situation
-> Meetings on “Renewal and Re-authorisation procedures” with COM, EFSA, ECPA, ECCA, IBMA, MS
- 30 October 2012 Brussels
- 12 December 2012 Brussels
- 14 March 2013 Brussels
- 16 September 2013 Brussels
- 10 and 11 March 2014 (PAI meeting, Brussels)
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2 – Current situation
•1 - Application
•2 - Compliance check
•3 - Assessment
•4 - Mixed products (products containing >1 active)
•5 - Data protection
•6 - Next steps
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2 – Current situation
1 - Application
Source: Kimdille
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2 – Current situation
• A number of submissions (applications for renewal of the product) needs studies which take >3 months time to be completed
Cat. 1 – “Formal” studies which do not impact the safety of the product (i.e. storage stability, validation of analytical methods)
Cat. 2 – Confirmatory information (approval regulation)
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2 – Current situation
Cat. 3 – Confirmatory information for AIR 2 substances (could be according to new data requirements)
Cat. 4 – Studies in order to fulfill new end points and time is too short to produce the studies required
(mesocosm studies, residue trials)
Cat. 5 – Data gaps related to new data requirements/new guidance documents
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2 – Current situation
Studies of cat. 1: not related to safety issues – no reason for extension
Studies of cat. 2, 3 and 5: confirmatory information -> renewal of the product without CI!
Studies of cat. 5: studies which are NOT confirmatory information – to be provided within 3 months
Studies of cat. 4: delay possible
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2 – Current situation
Studies of cat. 4 (remarks, questions):
- One assessment only (once all studies are provided)?
- When to be submitted?
- dRR to be provided? Once all studies are available?
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2 – Current situation
•Interpretation of Article 43(6): “reasons beyond the control of the authorisation holder”
If it is not possible for the applicant to provide studies in time (“new end point”) – no legal justification according to legal service´s opinion
- Applicant may justify the lack of data- MS may find it justified to apply Art. 43.6 and delay the re-authorisation- MS has the responsibility for ensuring that the protection standards are respected (“case by case”)
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2 – Current situation
• -> MS may grant extension of the concerned authorisation [cat 4 studies only]
• To be legally implemented
Proposal: a general statement in the substance renewal decision (approval regulation):“product authorisations should be extended for the time necessary to generate and evaluate the data needed “
Status? Not yet considered!
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2 – Current situation
• Application according to the timelines given in the regulation (i.e. 3 months after EIF of the approval regulation) – even if cat 4 studies are ongoing
• To be applied by all authorisation holders (i.e. notifying and non-notifying companies)[Note: no application means the authorisation to be revoked]
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2 – Current situation
• The application of dossiers (cat 4 studies ongoing) should contain
- All necessary studies available at the time of application
- List of studies to be generated, i.e. cat. 4 studies (including time table for study submission and justification – to be accepted by zRMS)
- dRR
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2 – Current situation
• The application of “incomplete” dossiers should NOT contain
- data related to additional uses (not yet authorised in the zone); those data are subject to extension of use, i.e. Article 33 application
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2 – Current situation
NOTE:
Source: Frater Tecum
•All authorisation holders (i.e. notifying and non-notifying companies to apply for renewal of the product within 3 months period – otherwise authorisation revoked)
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2 – Current situation
2 – Compliance check
Source: Bemthehack
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2 – Current situation
•Compliance with the conditions and restrictions of the active renewal/equivalence check if necessary after each substance´s renewal
•Compliance check to be performed by the individual MS having authorisations
•Equivalence check(s) to be performed by the RMS for the active renewal
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2 – Current situation
•Reference specification:
According to GD SANCO/10387/2010 rev 8 reference specification should not be changed unless a relevant impurity is to be included
Implications of a possible change- All equivalence checks (completed and ongoing) to
be reconsidered- A new specification would mean that different
material used in the tox/ecotox studies supporting the 1st approval
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2 – Current situation
3 - Assessment
Source: themonsterinmyhead
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2 – Current situation
•Assessment to be performed by the zRMS- One evaluation only once all cat. 4 studies are provided?- Assessment of sections for which all studies are made available first? Followed by an assessment when all cat. 4 studies are made available?
•Based on the dRR provided by the applicant (as for Article 33 applications)
•“new” consideration of the risk envelope approach (worst case GAP for one product – other products covered – applicable at least for sections residues and fate)
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2 – Current situation
4 - Mixed products
Source: rogueshollow
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2 – Current situation
• If 2 substances are renewed within a short timeframe (with a maximum of 1 year), the renewal of the product(s) will wait until the 2nd substance is renewed[Note: application after the 1st active is renewed!]
• To be considered:- What about substances which are renewed within e.g. 1 year and 1 month?- Sometimes not easy to anticipate, if the renewal of the second substance is delayed, which is not known after the 1st substance renewal
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2 – Current situation
• If the product contains > 2 actives:
Proposal of the expert´s group:
- if the approval of the substances is expiring in a short time frame, full evaluation of the product 5 years after the 1st substance is renewed (max. time period)
- 2 substances expiring earlier in a short period and 2 in the same (close) period later -> grouping
Not mentioned in the GD; same rules as for products containing 2 actives may apply
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2 – Current situation
5 – Data protection
Source: themonsterinmyhead
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2 – Current situation • Data protection (substance and product data) of 30
months starts at the date of renewal of the product (including studies which are provided later)
• If authorisation is extended (see chapter 1. application), data protection of 30 months starts once the authorisation is renewed
• Successive renewal of a product containing 2 actives may trigger 2 starting points for data protection (every time MS decide on the renewal of the product)
• For generics (products): MS should suspend for 30 months the authorisation of the product allready on the market (unless a LoA is available) – but application within 3 months necessary!
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2 – Current situation
6 – Next steps
Source: themonsterinmyhead
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2 – Current situation
•To be legally implemented
Proposal: a general statement in the substance renewal decision (approval regulation):“product authorisations should be extended for the time necessary to generate and evaluate the data needed “[still under consideration by COM]
•Amendment of the relevant GD SANCO/2010/13170 (conclusion of the expert´s meeting was implemented to some extent only due to legal service) – Standing Committee
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3 – Outlook
Source: RegularWeirds
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3 - Outlook
• How to coordinate the work between MS (zonal SC)
• “New” consideration of the risk envelope approach (worst case GAP for one product – other products covered!)
• In order to plan the work: information by applicants to MS about products to be renewed (2 years in advance to expected re-authorisation at the latest) – new notification sheet (implemented in the GD SANCO/2010/13170)
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3 - Outlook
• Worksharing of MS (interzonal, within the zone)
• Pre-submission meeting for renewal of the active – renewal of the PPP to be discussed as well
• Quality of the dRR prepared by the applicant
• Comparative assessment to be considered
www.ages.at
The horror is watching you!
Source: Terrorama.com.br
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