The document provides information on recent updates to the EU Falsified Medicines Directive and its requirements for safety features on medication packaging to help prevent falsified medicines. It discusses the growing problem of falsified medicines in Europe, the goals of the Falsified Medicines Directive to strengthen regulation of the pharmaceutical supply chain, and the delegated regulation outlining technical specifications for unique identifiers and anti-tampering devices that must be implemented by February 2019. It also addresses the roles and responsibilities of various stakeholders including marketing authorization holders, manufacturers, wholesalers, pharmacies and regulatory authorities in complying with the new regulations.

1. EU Falsified Medicines
Directive -
Recent Updates
Feb 2017
1

2. What are falsified medicines?
• Growing threat to public health and safety in Europe
• Involving nearly 2500 cases , EU Customs seized 27.4 million doses of
falsified medicines at EU borders in 2011- an almost seven-fold
increase from 2007
• MHRA seized £8.6m and discovered fraudsters are infiltrating the NHS
drugs supply chain and diverting medicines to street drug dealers and
illegal websites – May 2014
• Falsified medicines may:
• Contain low quality ingredients or the wrong doses
• Have their identity or source deliberately mislabelled
• Have fake packaging or the wrong ingredients
2

3. Falsified Medicines Directive (FMD)
20011/62/EU
3
• Directive published 1 July 2011
• Entered into force 1 January 2013
• Contains measures to increase security of
the medicinal supply chain in Europe
1. Strengthen Good Manufacturing and
Good Distribution Practices including
the sourcing of active ingredients
2. Improve supervision of actors in the
distribution chain (e.g. wholesalers,
parallel distributors and internet sales)
3. Ensure product integrity and
authentication of medicines (safety
features and product serialisation)

4. Delegated Regulation to the FMD
4
• Adopted on 2nd October 2015
• Published on 9th February 2016
• Enacting terms: Safety Features
1. Characteristics and technical specifications of
the unique identifier
2. Modalities for the verification of the safety
features
3. Establishment, management and accessibility of
the repository systems
4. List of RX medicines exempted from carrying
the safety features
5. Notification procedure for exceptions by
Member States
6. Procedure for rapid assessment of notifications

5. Requirements for safety features
Code (‘safety feature’)
+
Tamper evidence
 Unique identifier
 Data-Matrix Code
 Randomised serial number
Product #: 09876543210982
Batch: A1C2E3G4I5
Expiry: 140531
S/N: 12345AZRQF1234567890

6. ImplementationRequired in Member
States 3 years after publication
Objective: Protection of patients from falsified medicines in the
legal distribution chain
Content: Pan-European system to verify the authenticity of
medicinal products
2011
2018 (2015+3)
Complete
Implementation
9 February 2016
Publication of
Delegated
Regulation
July 2011
Publication of
FMD
36
Mon.
20192016
Non-compliance puts supply and sales at risk
2013
Jan 2013
FMD except
Safety Features
implemented *Italy, Belgium,
Greece have 6
years longer for
implementation

7. Regulatory Perspective
• Anti-Tampering Device:
– If placed on immediate packaging may impact the
regulatory dossier
– New MAs
• may need to include information ins section 3.2.P.2.4
and/or 3.2.P.7 of NTA Vol. 2B
• Information required by day 180
– Existing MAs
• Will need to update dossier
• Section B.II.e. of the Variation Guidelines applies
• Compliance by February 2019
https://www.gov.uk/guidance/medicines-packaging-labelling-and-patient-
information-leaflets

8. Regulatory Perspective
• Unique Identifier:
– Must be included in the product information annexes
and associated artwork
– QRD template – new sections 17 and 18 in Annex IIIA
• New MAs must comply at the time of authorisation
• Existing MAs
– Utilise the next regulatory intervention impacting
the packaging
– If no suitable intervention notify NCA under
article 61(3) of Council Directive 2001/83/EC
• Compliance by February 2019
https://www.gov.uk/guidance/medicines-packaging-labelling-and-
patient-information-leaflets

9. On Supply to Patient
• General provisions on the verification of the safety
features
–Check the UI against the numbers held in
the repository
–Ensure the tamper-evident feature is intact
• At the point of supply UI will be “decommissioned”
out of the repository
• UI can be checked back into the repository in certain
circumstances (10 Days)
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10. Manufacturers and Marketing
Authorisation Holders
• Impact on manufacturers
• Must develop system which will verify the UI
• Keep records
• If repacking must verify and replace UI and safety
features
• Safety features are deemed equivalent if they comply
with the delegated acts
• Must take action if concerns are raised and inform
the NCA
• If also a wholesaler dealer the following obligations
apply
Delegated Regulation –
Safety Features

11. Wholesaler Dealers
• Impact on Wholesalers
– Risk based verification
– Decommission the UI in specific circumstances
– Take action if issues arise and inform the NCA
– Can decommission the UI on behalf of others if
flexibilities used by Member State (Article 23)
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12. General obligations
• Companies to upload certain information to the
repositories (Master Data)
• Products recalled, withdrawn or stolen
–UI must be decommissioned
–Repository updated
• Free samples to have UI decommissioned before
supply to HCPs
• Remove redundant information
Delegated Regulation –
Safety Features

13. Flexibilities within the Regulation
• Member states may take National decisions on
some aspects of Delegated Regulation.
• Currently UK NCA are minded to
– Article 2(1)(c) - Extend scope of safety features
• Anti-tamper to any
• Not extend addition of 2D bar code
– Article 4, b,iii and Article 7, 1, c - Not require a National
Reimbursement Number within 2 D bar code
– Article 8 - Additional information in UI by manufacturers
– Article 23 - Require wholesalers to decommission for all
organisations listed
– Artile 26, 3 - Exempt individuals from obligations of verification and
decommissioning within Healthcare Institutions
Delegated Regulation –
Safety Features

14. NCA Timelines – key dates
• Developing initial UK position on flexibilities + legal
changes on enforcement: February-December 2016
• Developing initial impact assessment : February-
December 2016
• Public consultation (12 weeks): Proposed early 2017
• Review of consultation – amendments: Proposed Q2
and Q3 2017

15. Costs are incurred by all stakeholders
• Each stakeholder pays for costs of own installations
• Manufacturers pay for cost of verification system
Manufacturers and
Marketing Authorisation
Holders
Manufacturers and
Marketing Authorisation
Holders – contact EMVO to sign
up for European Hub testing
Dispensing & Verification
Entities
e.g. Pharmacies and
Wholesalers
Installation for pack codingVerification system
(Hub & national systems)
Installations for pack
verification
Pharmacy Wholesaler
Pharmaceutical
Manufacturer
Parallel
Distributor
European
Hub

16. European Principal Stakeholders developed
a European Stakeholder Model
16

17. Common Basic Concept:
Point of Dispense Verification
Required by
Delegated
Acts
17

18. Pan-European architecture:
The “National Blueprint System“ approach
National
System
Pharmacy
Wholesaler
Pharmaceutical
Manufacturer
Parallel
Distributor
National
System
National
System
European
Hub
National
System
National
System
National
System
National Blueprint
System
National Blueprint
System
National Blueprint
System
National Blueprint
System
18

19. The UK Stakeholders 2012-2015
• Meeting regularly since 2012, with ABPI, BAEPD, BAPW, NPA, PSNI, RPS,
• Co-operation and consensus vital
– Supporting European Stakeholder Model
• Keeping stakeholders informed:
– Associations’ own members
– The Competent Authorities
– Reaching out to other parts of the medicines supply chain
– Joint seminars
– EMVO documentation was important
• BGMA joins UK ESM – 2015
• RPS/PSNI drop off
• Incorporate the UK Medicines Verification Organisation – SecurMed UK

20. SecurMed UK – UKMVO

21. SecurMed UK
• A not for profit legal entity to establish and manage the verification system
• Incorporated by Articles of Association in July 2016
• Supervised by National Competent Authority (DoH/MHRA)
• Scope governed by Delegated Regulation of Falsified Medicines Directive

22. European
Medicines Verification
System (EMVS)
Interface
Interface
Manufacturer
Paralell
Manufacturer
System
Parallel
Distributor
System
Interface
Nat’l System
UK National Medicines
Verification System
(NMVS)
Interface
Pharmacy
Interface
Wholesaler
Wholesaler/
Distributor
System
Interface
Hospital
Interface
Other
Community
Pharmacy
System
Hospital
Pharmacy
System
Other
Dispensing
System
Integrated
PMR
Standalone
Application
NHS
Hospital
Pharmacy
Private
Hospital
Pharmacy
Dispensing
Dr
Other
Dispensing
Organisation
National Verification Systems Overview
European Medicines
Verification
Organisation (EMVO)
UK National
Medicines Verification
Organisation (NMVO)
• Branded
• Generic

23. European
Medicines Verification
System (EMVS)
Interface
Interface
Manufacturer
Paralell
Manufacture
r
System
Parallel
Distributor
System
Interface
Nat’l System
UK Medicines
Verification System
(UK MVS)
Interface
Pharmacy
Interface
Wholesaler
Wholesaler/
Distributor
System
Interface
Hospital
Interface
Other
Community
Phamacy
System
Hospital
Pharmacy
System
Other
Dispensing
System
Integrated
PMR
Standalone
System
NHS
Hospital
Pharmacy
Private
Hospital
Pharmacy
Dispensing
GP
Other
Healthcare
Dispensing
Organisation
SecurMed UK Scope of Responsibility
Article 23
Locations
• Under NCA supervisory control
• Build UK MVS repository and on-board
wholesale/ pharmacy/ dispensing users
• Develop business operational processes (e.g
decommissioning)
• Provision of NMVS Repository to pharmacy
user community for medicines verification
• Provide interfaces to pharmacy user/
software integrator community
• Maintaining and operating UK MVS
• Maintain service contracts with system
service provider and EMVO
• Collect operational fees from MAHs
• Reporting exceptions & compliance to
NCAs.
• Maintain data integrity and security

24. Outline Plan on a Page

25. Who will have to pay ?
Pharmacists, wholesalers, …
Installations for
pack verification
Marketing Authorisation
Holders
Installations for
pack coding
Marketing Authorisation
Holders
Repository system
(Hub & national systems)
Pharmacy Wholesaler
Pharmaceutical
Manufacturer
Parallel
Distributor
European
Hub
MAHs selling products in a Member State pay for respective national
system and a share of the European Hub
25

26. National Full Operation Costings
National system cost estimateSep 2015 26
System cost
x k€
Average of IT service providers’ offers
Pre-negotiated offers vary between
average +/- 50%
NMVO cost
x k€
As per system size
Hub cost
x k€
Share: x % (Approx double during first 3
years to pay off loans)
Total: x k€
Annual fee per MAH: x k€
Flat fee model

27. Cost allocation:
The Flat fee model
• The flat fee is transparent, non-discriminatory and proportionate in relation to
the services received.
• Practicality
• Easy way of calculating: equal division amongst MAHs and PD
• Fairness
• Takes into account market activity: companies with multiple MAHs pay more
• Transparency
• Simple accountancy / audit
• Predictability
• Calculations based on number of active participants in the market the year
before the fee adjustment
• Balanced
• A larger company often hold multiple MAH’s so will pay multiple ‘flat fees’
• Upfront payment
• In order to prevent free-riders, easy calculation gives opportunity to pay
upfront

28. FMD AND BREXIT
• Article 50 (Brexit) – March 2017 plus 2 years
• FMD legislation passed into UK law in 2013.
• Delegated Regulation published February 2016 plus 3 years
• DH guidance
• Maintain integrity of UK medicines supply chain
• Continue with implementation and contract service
provider

29. What should manufacturers do Next?
• Prepare own serialisation and packaging lines
• Engage with EMVO to ensure ready to upload
data
– Participation Request
– Legitimacy Check
– Contractual/Commercial On-boarding
• Registration
– Technical Onboarding
• Connection/Testing/Operation
• Understand Data Requirements
– Master Data

30. Paul Mills, 19th Oct 2016, securMed
EMVS Master Data
30
Product Master Data
Product code
Coding scheme
Name
Common name
Pharmaceutical form
Strength
Pack type
Pack size (Dose Count)
Product Code Status
Product Code Version
Product per Market Data
Member state ISO ID
National code
Article 57 code/PCID (TBC)
MAH ID
MAH Name
MAH Address
Serialisation Flag
List of Wholesalers with ID, name
and address
Batch Data
Batch number
Expiry date
Manufacturer ID
Manufacturer Name
Manufacturer Address
Batch Number Status
Pack Data
Serial Number
Serial Number Status
1
N
1
1
N
N