FMD User Guide - Positive Solutions · FMD comes into effect on 9th February 2019. This registration process is widely referred to as on-boarding. This FMD On-Boarding Guide has been

Version 2.3.1

FMD User Guide SecurMed Registration

(On-Boarding)

FMD User Guide

v.1 Analyst PMR Dispensing Workbook A

November | Page 1

©Positive Solutions Ltd 2018

v.2.3.1 FMD SecurMed Registration (On-Boarding) Guide

22nd January 2019| Page 1


Contents This User Guide is intended as a resource to support your use of the MediSyn solution in accordance with the Falsified Medicines Directive.

1. Introduction 2 2. The UK Medicines Verification System (UKMVS) 3 3. Summary 4 4. Glossary 5

Terminology 5 5. Registration Process 6

A Step Guide to Single Registration 7 - Step 1 - Accessing the SecurMed Portal 7 - Step 2 - Creating an Account 8 - Step 3 - Signing In to your Account 9 - Step 4 - End User Location Registration (Single) 10

What Happens Next (Single Registration) 13 6. Data Field Definitions (Single Registration) 14 7. A Step Guide to Bulk Registration 18

- Step 1 Accessing the SecurMed Portal 18 - Step 2 Creating an Account 19 - Step 3 Signing In to Your Account 20

8. What Happens Next (Bulk Registration) 22 9. Data Field Definitions (Bulk Registration) 23 10. Standard Operating Procedure (SOP) 25 11. Web Browsers 26

Help & Support 27 Please Note: The material in this User Guide is for information purposes only. The products described may be subject to change at short notice. Positive Solutions makes no representations of warranties with respect to this manual or the products herein described, nor shall it be liable for any damages, losses, costs or expenses - direct, indirect or incidental, consequential or special, arising out of or related to the use of this material or the processes herein described.

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Introduction The Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) impose regulatory obligations on all Pharmaceutical Manufacturers, Parallel Distributors, Marketing Authorisation Holders, Community Pharmacies, Hospital Pharmacies, GPs, Health Centres and Pharmaceutical Wholesalers. The legislation comes into force on 9th February 2019 by which time end users must be ready to implement FMD. The scope of FMD covers all prescription only medicines (POMs) as set out in regulation 2016/161/EU. Exceptions to the regulation for some medicines are listed in Annex I and II of the Delegated Regulation. Manufacturers, Parallel Distributors and Marketing Authorisation Holders are required to make changes to their POM packaging and labelling to add anti-tamper proof devices, additional human readable information and a 2D machine readable matrix to enable scanning of medicines. In addition, they are required to upload the human readable information to a Europe-wide database for verification and decommissioning of medicine packs by end users. Community Pharmacies, Hospital Pharmacies, GPs, Health Centres and Pharmaceutical Wholesalers are required to make changes to their business process and IT systems to enable them to verify and authenticate medicines as they travel through the supply chain to dispense to patients. IT systems are required to create a connection to the UK Medicines Verification System (UKMVS).

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The UK Medicines Verification System SecurMed is the UK national medicines verification organisation that will enable your pharmacy to scan, check and decommission medicines at the time of supply to the patient. The organisation is working with stakeholders across the medicines supply chain to enable the EU Falsified Medicines Directive to be implemented in the UK by the go-live date of 9th February 2019. All End Users affected by FMD regulatory obligations are required to register with the UKMVS before FMD comes into effect on 9th February 2019. This registration process is widely referred to as on-boarding. This FMD On-Boarding Guide has been published to support on-boarding registration with SecurMed by end users of Analyst PMR Integrated FMD solutions and MediSyn FMD solutions.

Inclusions Positive Solutions FMD software and hardware solutions:

Þ Analyst PMR Integrated FMD solution (software to be installed Jan 2019) Þ MediSyn standalone solutions (software already installed)

SecurMed Single Registration

Þ An End User Location.

Þ An End User Location with more than a single function e.g. a community pharmacy with wholesale activity. This will require a Single Registration for each function at the same location.

Þ Pharmacy groups of more than five End User Locations (branches). These may EITHER § repeat the Single Registration process for each End User Location OR § proceed with the Bulk Registration process.

SecurMed Bulk Registration

Þ On-boarding of multiple End User Locations within the same Parent Company or Group at the same time.

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Summary The following steps are required for the implementation of FMD by 9th February 2019:

1. Purchase of Honeywell VMD-ready Xenon 2D scanner with intelligent area imager to scan the new 2D Data Matrix, also known as the unique identifier (UI) code.

2. Creation of User Account with SecurMed in order to proceed with registration (on-boarding)

3. Registration with SecurMed (on-boarding) either Single or Bulk Registration

4. Receipt of login details from SecurMed (approx. 15 days after registration)

5. Receipt of link for Software Certificate from SecurMed (approx. 15 days after registration)

6. Application of SecurMed Software Certificate and Installation of MediSyn FMD Software by Positive Solutions Service Desk(I)

Important! - Installation CANNOT proceed without the following information provided by SecurMed on completion of registration (on-boarding):

a) MVS Username (format = EXAMPLE/123456789) b) Initial Password (format = Pa5sWord!) c) NMVS TAN Code (format = tH1siSaTaN)

7. Change of Password

(I)Please note:

Prior to calling the Service Desk (Step 6) to arrange the service, Steps 1-5 above MUST be completed.

Please note: (I)Service Desk support is available to Positive Solutions customers for the implementation of this installation process. Prior to calling the Service Desk to arrange the service, Steps 1-5 above MUST be completed.

Independent Pharmacy Customers – please contact the Service Desk on 01257 235940 to arrange an appointment for remote installation.

Corporate Account Customers – please contact your Account Manager to make the necessary arrangements for remote installation.

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Glossary

• FMD – Falsified Medicines Directive

• NMVS – National Medicines Verification Service

• EMVS – European Medicines Verification Service

• UKMVS – United Kingdom Medicines Verification Service

Terminology

• Requestor – The person who can Register End User Locations.

• End User Location – The Name of Legal Entity and Address Location from which medicines are dispensed.

• End User Location Contact – The person authorised to dispense medicines from that location and receive the logon access credentials.

• End User Location Function – The principle function of the dispensing location (e.g. Pharmacy, Dispensing Surgery, Wholesaler).

• Software Supplier – The vendor of the software you will use to access the UKMVS.

• User Name and Password – The login credentials required to access the UKMVS.

• Software Certificate – A small piece of code that works in unison with the User Name and Password to verify the End User Location to the UKMVS. Depending on your IT setup this may be installed on all terminals or computers within the End User Location or may be installed on a central server through which all dispensing transactions are routed from the terminals or computers in the location.

• Single Registration – Registration of a Single End User Location for a single Function. An End User Location that has more than a single function will require a Single Registration for each function at the same location.

• Bulk Registrations – Registration of multiple End User Locations within the same Parent Company or Group at the same time.

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The Registration Process Registration –widely referred to as on-boarding- is the process to ensure pharmacy locations are connected to the UK Medicines Verification System for FMD.

The SecurMed on-boarding website https://www.securmed.org.uk/register/end-user-registration/ is open and end users are advised to register as soon as possible.

If an End User Location performs more than one function, a separate registration must be completed for each business activity e.g. Community Pharmacy with a Wholesaler Licence, the business must be registered as two individual End User Locations.

Registration is the responsibility of the Pharmacy Contractor (or other end user).

Registration cannot be completed without the following information about MediSyn FMD solutions:

• Name of the legal body and address for the End User Location • End User Location Function(s) • Registration body for the Location and Registration ID • Name, Email and Business Phone for the End User Location Contact • Software Supplier Name: Positive Solutions Ltd • Software Name: MediSyn (Message broker & Console) • Software Version: Analyst v3.61

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A Step Guide to Single Registration

* Please note Registration cannot be completed without the following information:

§ Name of Legal Entity, as it appears in the Authorising or Registration database § Registered Address for the End User Location § End User Location Function(s) § Authorising or Registration Body for the Location and Registration ID § Name, Email and Business Phone for the End User Location Primary Contact § Name and Email for an End User Location System Contact § Your Software Supplier Name, Software Name and Version

Þ Completion of fields marked * is mandatory.

STEP 1 – Accessing the SecurMed Portal

a) Go to the SecurMed registration portal at

https://www.securmed.org.uk/register/end-user-registration/

b) Read the entire page before proceeding.

c) Download the End User Licence Agreement (EULA) from the webpage and read it carefully before accessing or using the UKMVS.

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d) When you’re ready to proceed with your

registration (on-boarding), click on Click Here to Continue with Registration at the bottom of the webpage.

STEP 2 – Creating an Account *If you already have an Account, continue to STEP 3 Sign In below.

a) You need to create an online Account in the SecurMed system before you can Register an End User Location.

b) Your Account can be used to register any number of End User Locations.

c) To create your Account click the Sign In link in the menu bar of the web page.

d) Select Register.

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e) Complete the information requested and click Register.

f) Complete the information to create your End User Location Profile.

g) You should receive an email with your account details straight away.

h) You can now proceed to the Account Sign In process outlined below.

STEP 3 – Signing In to your Account

a) Go to the portal https://securmed-portal.microsoftcrmportals.com/

b) Select Sign In

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c) Select Sign in from the SecurMed login page d) Enter your email and password and sign in.

STEP 4 – End User Location Registration (Single)

a) Enter the details for the End User Location you are registering.

b) The name of the Legal Entity should be as it appears in the authorising or registration database (when you created your SecurMed account).

c) The Address should be the registered address for the location being entered.

*Please note Make sure you select the correct option from the drop-down choices in the fields for Region, Function of Location and Registration Body. d) If your End User Location performs more

than one function e.g. Community Pharmacy and a Wholesaler, you must register as two individual End User Locations. When you have completed your first/current registration, you can proceed with another registration.

e) Ensure all your details are entered correctly, click on Next to save and continue.

f) A Reference Number for your registration will be generated.

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g) Your reference number is now shown at the top of the web page.

h) Enter your End User Location Contact information.

i) Enter a separate contact or mailbox to receive system messages from UKMVS e.g. system alerts, update messages.

j) Review all the information you have entered, then click Next to save and continue.

k) Your reference number continues to be shown at the top of the web page.

l) Enter your Software Supplier Name, Software Name and Version for MediSyn.

• Software Supplier Name: Positive

Solutions Ltd • Software Name: MediSyn (Message

broker & Console) • Software Version: Analyst v3.61

m) Review all the information you have entered, then click Next to save and continue.

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n) Your reference number continues to be

shown at the top of the web page. o) Review the Summary of your data now

being displayed on screen. p) Use the Previous button to return to

previous pages to make any amendments.

q) When you’re satisfied all the information

is correct, click Next to save and continue to the EULA acceptance page.

r) Your reference number continues to be shown at the top of the web page.

s) You must accept the EULA to complete

the registration process.

t) Click the check box to confirm acceptance.

u) Click Accept to submit your application

for registration (on-boarding).

v) Confirmation of your completed registration appears on screen, together with your reference number.

w) You now have the opportunity to

register another End User Location.

x) If you have no further locations, you may log out of your account.

y) You will receive further communication

from SecurMed in due course – see further information below.

a)

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What Happens Next Single Registration

1. Your details will be checked against the Safety Features Delegated Regulation, to ensure

your End User Location(s) is authorised for the dispensing and/or wholesale wholesaler of medicines.

2. Should any issues be encountered, you will be contacted by a member of the SecurMed

Customer Service team.

3. On successful verification, your data will be uploaded to the UK MVS.

4. The Named Person at the End User Location will be issued with the following information for each End User Location you have registered: § User Name delivered by postal service; § Password delivered by postal service; § Software Certificate in the form of a link for you or your Software Supplier to download

for use with your FMD software.

5. The above information will be required to successfully login to the UK MVS.

6. If you have not received this information within 15 days, please contact SecurMed UK at [email protected]

7. All communications from SecurMed and from your Software Supplier should be stored in a secure and easily accessible location. These will be required for the installation of the SecurMed Security Certificate and MediSyn FMD software on your Analyst PMR system.

8. You will receive further communication from Positive Solutions Ltd before 31st January 2019 with regard to the installation of the SecurMed Security Certificate and MediSyn FMD software on your Analyst PMR system.

9. Positive Solutions will provide all customers with full support and guidance for the implementation of its integrated and standalone MediSyn FMD software solutions.

*Important

§ All communications from SecurMed and from your Software Supplier should be stored in a secure and easily accessible location. These will be required at a later date for registration and/or security confirmation.

§ Standard Operating Procedures (SOPs) should be updated prior to 9th February 2019.

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Data Field Definitions Single Registration

2. Definitions and purpose of the data fields for Single Location registration shown below.

The semi-colon symbol (;) must NOT be used in any field.

Field name Format Definition Purpose Requestor Registration Email (becomes the user name)

Mandatory email format

The user name of the person submitting the registration. This can be anyone authorized to act on behalf of the legal entity for the purposes of FMD

This will be the email address used to return some of the system credentials and point of contact for any queries. This person will also be required to accept the EULA T&Cs on behalf of the legal entity.

Email Auto populates from email Email address from above

User Name for registering person

Used every time the registering person accesses the portal: to register a location, amend an incomplete registration, or register more locations.

Password Mandatory Free Text Rules apply Security Confirm Password Mandatory Free Text Requestor Profile First Name Mandatory Free Text First name Used by SecurMed

support for contact Last Name Mandatory Free Text Last name Used by SecurMed

support for contact

Field name Format Definition Purpose E-mail Auto populated Email address from first

registration Used by SecurMed support for contact

Business Phone Mandatory Free Numeric?

Optional Used by SecurMed support for contact

Other Phone Free Numeric? Optional Used by SecurMed support for contact

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End User Location Data Reference Number Autogenerated Number

Field System generated unique reference number

Use this number in any contact with SecurMed support.

Name of Legal Entity Mandatory Free Text As it appears in the appropriate regulatory register (e.g. GPhC) for the location

Used as part of access authentication and verification

Postal Code Mandatory Validated Free Text

As used by UK Postal service

Used as part of access verification and for addressing credentials sent by post

City or Town Mandatory Free Text Address Line Mandatory Free Text Used as part of access

authentication and verification

Address Line 2 Free Text Address Line 3 Free Text Country/state Free text Region Mandatory Drop Down

List (DDL) Channel Islands, IoM, England, Northern Ireland, Scotland, Wales

Used to facilitate the verification process which differs between devolved authorities.

Function of Location Mandatory Drop Down List (DDL)

What type of business is conducted at this location: Wholesaler, Pharmacy etc

Defines which transactions are assigned to the user

Field name Format Definition Purpose Registration Body Mandatory DDL The body with which

the Location is registered


Name of Other Mandatory Dynamic Free Text

Additional field if none of DDL entries are the correct registering body


Registration ID Free Text Unique number assigned by registering body to the Location


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End User Location Contact Data First Name Mandatory Free text A suitable name to

address postal correspondence sent to registering address. (This person does not have to work at this address)

Used for addressing credentials sent by post (note: required for bulk applications but not necessarily used)

Last Name Mandatory Free text A suitable name to address postal correspondence sent to registering address. (This person does not have to work at this address)

Used for addressing credentials sent by post (note: required for bulk applications but not necessarily used)

Email Mandatory Email format

Business Phone Mandatory Numeric

Used by SecurMed support for contact

Other Phone Numeric Optional Used by SecurMed support for contact

System contact First Name Mandatory Free text The name of the person

who should receive system messages by email (can be the same as previous named roles)

Used by system to send emails including password change reminders

Field name Format Definition Purpose Last Name Mandatory Free text The name of the person

who should receive system messages by email (can be the same as previous named roles)

Used by system to send emails including password change reminders

email Mandatory email format

Used by system to send password change reminders

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Software Supplier Data Software Supplier Name

Mandatory Free Text Software supplier name as used on SMS Arvato portal

The software will need to have passed testing on the Arvato SMS portal to progress registration – checked by SecurMed. We will contact the registering person by email if the information supplied here is not sufficient or software/name/version has not passed testing.

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A Step Guide to Bulk Registration

*Please note

Registration cannot be completed without the following information: § Name of Legal Entity, as it appears in the Authorising or Registration database § Registered Address for the End User Location § End User Location Function(s) § Authorising or Registration Body for the Location and Registration ID § Name, Email and Business Phone for the End User Location Primary Contact § Name and Email for an End User Location System Contact § Your Software Supplier Name, Software Name and Version

Þ Completion of fields marked * is mandatory.

STEP 1 – Accessing the SecurMed Portal

e) Go to the SecurMed registration portal at

https://www.securmed.org.uk/register/end-user-registration/

f) Read the entire page before proceeding.

g) Download the End User Licence Agreement (EULA) from the webpage and read it carefully before accessing or using the UKMVS.

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h) When you’re ready to proceed with your

registration (on-boarding), click on Click Here to Continue with Registration at the bottom of the webpage.

STEP 2 – Creating an Account *If you already have an Account, continue to STEP 3 Sign In below.

i) You need to create an online Account in the SecurMed system before you can Register an End User Location.

j) Your Account can be used to register any number of End User Locations.

k) To create your Account click the Sign In link in the menu bar of the web page.

l) Select Register.

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m) Complete the information requested and click Register.

n) Complete the information to create your End User Location Profile.

o) You should receive an email with your account details straight away.

p) You can now proceed to the Account Sign In process outlined below.

STEP 3 – Signing In to your Account

c) Go to the portal https://securmed-portal.microsoftcrmportals.com/

d) In the top right corner of the screen, Select Sign In.

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e) Select Sign in from the SecurMed login page

f) Enter your email and password and sign in.

g) The following drop-down options are available from the menu bar at the top of the screen, under the Registration button: • Single Registration • Continue Single Registration • Bulk Registration

h) Select Bulk Registration and follow the

instructions on-screen.

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What Happens Next Bulk Registration

1. Your details will be checked against the Safety Features Delegated Regulation, to ensure

your End User Location(s) is authorised for the dispensing and/or wholesale wholesaler of medicines.

2. Bulk Registration requires verification and processing, by SecurMed, of all the pharmacy data entered during registration.

3. Should any issues be encountered, you will be contacted by a member of the SecurMed Customer Service team.

4. During verification and processing, all data uploaded by the End User will be stored securely within the SecurMed system. The format and integrity of the data entered will also be confirmed.

5. The Pharmacy End User Contact will receive communication from the SecurMed Customer Service Team within 15 days to confirm:

• Next steps for registration • Anticipated timeline for completion of registration • Delivery of End User login details

6. On successful completion of the verification process by SecurMed, the End User data will be uploaded to the UK NMVS.

7. The Named Person at the End User Location will be issued with the following information • User Name delivered by postal service • Password delivered by postal service • Software Certificate in the form of a link for you or your Software Supplier to

download for use with your FMD software.

8. The above information for each End User Location will be required to successfully login to the UK MVS.

9. If you have not received this information within 15 days, please contact SecurMed UK at [email protected]

10. All communications from SecurMed and from your Software Supplier should be stored in a secure and easily accessible location. These will be required for the installation of the SecurMed Security Certificate and MediSyn FMD software on your Analyst PMR system.

11. You will receive further communication from Positive Solutions Ltd before 31st January 2019 with regard to the installation of the SecurMed Security Certificate and MediSyn FMD software on your Analyst PMR system.

12. Positive Solutions will provide all customers with full support and guidance for the implementation of its integrated and standalone MediSyn FMD software solutions

*Important § All communications from SecurMed and from your Software Supplier should be stored in a

secure and easily accessible location. These will be required at a later date for registration and/or security confirmation.

§ Standard Operating Procedures (SOPs) should be updated prior to 9th February 2019.

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Data Field Definitions Bulk Registration

3. Definitions and purpose of the data fields for Bulk registration.

*Please note Only the requestor registration and profile fields are required to be entered in the online portal for Bulk entries. All other fields must be entered in the Excel file submitted for each location registered in the Bulk registration process. The semi-colon symbol (;) must NOT be used in any field. Field name Format Definition Purpose Requestor Registration Email (becomes the user name)

Mandatory email format

The user name of the person submitting the registration. This can be anyone authorized to act on behalf of the legal entity for the purposes of FMD

This will be the email address used to return some of the system credentials and point of contact for any queries. This person will also be required to accept the EULA T&Cs on behalf of the legal entity.

Email Auto populates from email Email address from above

User Name for registering person

Used every time the registering person accesses the portal: to register a location, amend an incomplete registration, or register more locations.

Password Mandatory Free Text Rules apply Security Confirm Password Mandatory Free Text Requestor Profile First Name Mandatory Free Text First name Used by SecurMed

support for contact Last Name Mandatory Free Text Last name Used by SecurMed

support for contact

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Field name Format Definition Purpose E-mail Auto populated Email address from first

registration Used by SecurMed support for contact

Business Phone Mandatory Free Numeric?

Optional Used by SecurMed support for contact

Other Phone Free Numeric? Optional Used by SecurMed support for contact

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Standard Operating Procedure (SOP) ALL types of Registration

1. Standard Operating Procedures (SOPs) should be updated prior to 9th February 2019.

2. Community Pharmacy SOPs should account for the following processes:

• Checking of Anti-Tamper Devices. • Scanning of unique 2D codes. • Performing 2D barcode checks against the National Medicines Verification System. • Authentication and decommissioning of all relevant prescription medicines during the

dispensing process, prior to hand-over to patients. • Unexpected results e.g. product recalls, identification of falsified medicines.

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Web Browsers ALL types of Registration

A current web browser should be used when registering (on-boarding). The following browsers are supported:

§ Microsoft Edge (Internet Explorer 12) § Internet Explorer 10 and 11 § Safari (latest version, Mac only) § Chrome (latest version) § Firefox (latest version)

*Please note The SecurMed Portal may need to be added as a trusted site within your security network.

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Help & Support

A full Analyst PMR Manual is included on the Analyst system. To access the manual, either: § select Help > Contents > Index from the top of your Analyst screen. § press F1 on the keyboard

The contents may be browed on the left of your screen or the Search box at the top right of your screen can be used to search for something specific.

Positive Solutions Service Desk (t) 01257 235940

(e) [email protected]

Monday to Friday 0800 – 1830hrs Saturday 0800 -1300hrs Sunday Closed

https://fmdsource.co.uk/introduction-to-fmd/

Documents

FMD User Guide - Positive Solutions · FMD comes into effect on 9th February 2019. This registration process is widely referred to as on-boarding. This FMD On-Boarding Guide has been