This slide deck gives background to, and an update on, the Falsified Medicines Directive and Delegated Regulation. More more information about the FMD, please visit: http://www.abpi.org.uk/our-work/falsified-medicines-directive/Pages/default.aspx

1. ABPI Briefing
Falsified Medicines Directive
October 2016
1

2. Today’s Agenda
• 11.00am Welcome
• 11.05am FMD – UK Update
• 11.30am FMD – View from the MHRA
• 12.30pm FMD – EU Update
• 1.00pm Close
2

3. 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
3

4. Falsified Medicines Directive (FMD)
20011/62/EU
4
• 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)

5. Delegated Regulation to the FMD
5
• 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

6. 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

7. 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

8. 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

9. European Principle Stakeholders developed
a European Stakeholder Model
9

10. Common Basic Concept:
Point of Dispense Verification
Required by
Delegated
Acts
10

11. 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
11

12. 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

13. UK Principle Stakeholders
System set up and governed
by stakeholders under
supervision of national
competent authorities

14. Development of UK Partners
• Adoption of Interim UK Memorandum of Understanding
(MOU) and then more formal Framework MoU
• ‘Observer group’ formed including:
– DH/MHRA
– RPS, DDA,
– Guild Hospital Pharmacists
• Full engagement with Competent Authorities
– MHRA letters to all MAHs and WDA holders – Nov
2015 and June 2016
– Membership of DH/MHRA FMD Implementation
Board & associated workstreams
– MHRA Impact Assessment work - manufacturers site
visits

15. Where Are We Now?
• BREXIT
• Formal Consultation with wider stakeholders - Summer
– MoU and URS lite
• Incorporation of UKMVO – SecurMed UK - Summer
– Articles/Statutes
– 5 Directors (1 Director per Constituency) – voting and
Annual Constituency Fee agreed
– Officials rotate every 6 months – secretariat in place
– 6 Full members
– MHRA/DH in attendance at Board meetings

16. Where Are We Now?
• Selection of BSP – Autumn
– ‘Request for Proposal’ issued to 3 BSP’s
– Proposals and Pitches to every Constituency – August
– Additional clarification
– BSP’s advised of next steps – end of September
• Open formal negotiations with 2 ‘preferred providers’
• Recruit General Manager - Autumn
– Job Description – end of September
• ABPI Briefing
– MHRA and EMVO input – 19th October

17. 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
17

18. Mechanisms for system funding in
different phases
2014 2015 2016 2017 2018
Design and Development
Phase (funding:
EFPIA/ABPI)
Ramp Up Phase
(funding: loans from
member companies at
National and EU)
Full Operation Phase
(funding:
all MAHs via
NMVO’s)
2019 2020

19. Phased-in: 3 phases
• Start-up phase:
– Financed by EFPIA/ABPI
• Ramp-up phase: Total Europe wide Costs - €90Million
– Period of connecting companies and national / regional repository
systems with the EU-hub up to almost complete level of participants
– Expected to start early-2016 and last until end-2018 (based on
provisions of the FMD coming into effect February 2019)
– Monies collected at both EU and National level – Loans not Levies!
• Full operations phase: Total Europe wide Costs - €90Million/Annum
– Period after the ramp-up phase is finished.
– Post February 2019
– Monies collected via NMVO’s – Flat rate per Marketing
Authorisation Holder
19

20. National Ramp-Up Costings
National system cost estimateSep 2015 20
System cost
x k€
IT service providers’ proposals
NMVO cost
x k€
Set-Up, Pilot and Admin/Governance Costs
Total: x k€
Loan per Company: x k€
Loan Model

21. National Full Operation Costings
National system cost estimateSep 2015 21
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

22. 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

23. SecurMed UK
Organisational Structure
• General Manager
– Leads and manages the project at SecurMed UK
– SecurMed UK Finance and resource provision
• System Manager
– Technical understanding of national processes and systems, including PMR,
hospital and wholesaler IT systems and others when Article 23 flexibilities
agreed.
• Stakeholder Manager
– Organise communication including marketing activities
– Coordinate rollout validation, registration and certification (on-boarding) of
system users, including CRM (database) management
• Quality Manager
– Develop KPI’s, reports and audits
– Investigation of Exceptional Events/Alerts
– Lead for engagement with MHRA/GPhC and others re system user
identification and pre on-boarding validation
• Board Secretariat/Administration
– Secretarial support for Board and Management Meetings

24. Progress across Europe
• 6 NMVO’s Founded
• 3 Selections announced (Finland, Norway and Sweden)
• 2/3 Countries behind schedule
• 9 Countries not yet engaged with BPS’s
• Several countries without stakeholder alignment (pharmacy
and wholesalers)
• 37 companies started on-boarding to EU Hub
• 8 fully connected to EU Hub

26. 26
Falsified Medicines Directive -
‘Safety Features’
ABPI presentation – 19 October 2016
Jan MacDonald

27. 27
Overview of progress
• Implementation Advisory Board (IAB) and Working Groups:
– IAB meets on a quarterly basis with representatives from across the UK
supply chain. It’s role is to provide recommendations.
– Working groups: Seven working groups have met (including Community
Pharmacy & Wholesales). We are now seeking to join meetings to continue
to capture the views of stakeholders.
• European Commission:
– Continuing our engagement with the Commission through attendance at
expert group meetings.
– Commission aim to create working groups on four areas: (1) supervision, (2)
access to information/data in the repository, (3) data traceability and (4) best
practice. UK plan to participate.
• SecurMed:
– Continuing to work with the SecurMed in our supervisory role.

28. 28
Impact Assessment
As a part transposition we assess the impact of the directive on the UK. This
“impact assessment” will consider both the costs and benefits of the Safety
Features policy.
The impact assessment will be published in two parts:
• Consultation impact assessment: This will be published with evidence gaps
showing our initial analysis on the impact of the proposal on the UK, and our
decisions on any flexibilities we have under the act. At this point the public has
the opportunity to write in and formally provide evidence and opinions on our
assessment of the impact and the policy decisions we are proposing.
• Final impact assessment: This will take account of the evidence provided
during the consultation, and assess the impact of the final policy decision.
We are currently in the process of visiting businesses impacted by Safety
Features.
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29. 29
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

30. 30
Safety Features
Introduced to enable manufacturers,
wholesale distributors and those who supply
to patients:
• to verify the authenticity of the medicinal
product,
• to identify individual packs,
• to verify, by means of a device, whether
the outer packaging has been tampered
with
• Published February 2016
• UK has 3 years to implement
Delegated Regulation – Safety Features

31. 31
• 2D bar code with a unique identifier
• Tamper evident packaging
• Affects all prescription medicines (unless
exempted)
POM
• No P or GSL products impacted (unless an
issue of falsification has been notified)
P & GSL X
Delegated Regulation – Safety Features

32. 32 Delegated Regulation – Safety Features

33. 33
Tamper Evidence
• Medicines required to include the safety
features need to include anti-tampering devices
• CEN standard already approved
“Tamper verification features for medicinal product
packaging – EN 16679:2014”
• Choice will be for the MAH/manufacturer to
determine
Delegated Regulation – Safety Features

34. 34 Delegated Regulation – Safety Features

35. 35
Chapter 2 – Unique Identifier
• Technical specifications of the UI
– Sequence of alpha-numeric or numeric characters given to
individual pack
– Code allowing identification of the name, common name,
pharmaceutical form and strength as a minimum
– Reimbursement information if required by MS
– Batch number
– Expiry date
• 2D data matrix carrier
• Human readable format in addition
• No other codes may be displayed
Delegated Regulation – Safety Features

36. 36 Delegated Regulation – Safety Features

37. 37
EU-wide implementation plan
• Anti-Tampering Device
• Does not impact the PI templates
• If placed on immediate packaging may impact the
dossier
1. 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
2. Existing MAs
– Will need to update dossier
– Section B.II.e. of the Variation Guidelines applies
• Compliance by February 2019

38. 38
EU-wide implementation plan
• Unique Identifier:
• Must be included in the product information annexes and
associated artwork
• QRD template – new sections 17 and 18 in Annex IIIA
1. New MAs must comply at the time of authorisation
2. 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

39. 39
Chapter 3 – Verification
• 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 “checked-out” of the
repository
• UI can be checked back into the repository in certain
circumstances
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40. 40
Chapter 4 – Manufacturers
• Impact on manufacturers
– Must 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 obligation following
apply
Delegated Regulation – Safety Features

41. 41
Chapter 5 – 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 have been used by MS
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42. 42
Chapter 8 – General obligations
• Companies to upload certain information to the
repositories
• 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

43. 43
Flexibilities within the Regulation
• Member states may
– Extend the products to which the unique
identifier/safety feature applies
– Require a national reimbursement or other national
number to be within the data elements of the unique
identifier
• Member states may allow
– Manufacturer to put additional information in the bar
code
Question for discussion: your view on use of these flexibilites
Delegated Regulation – Safety Features

44. 44
Information to support the
impact assessment –
We are interested in looking at the areas of the business that
will require a process change or new equipment, and we are
interested in the views of manufacturers of any costs and
benefits associated with these changes.
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45. 45
Other concerns:
Delegated Regulation – Safety Features

46. dd/mm/yyyy
On-boarding and Data Management
Paul Mills

47. Paul Mills, 19th Oct 2016, securMed
Onboarding - Introduction
 EMVO is tasked with the on-boarding activities for
manufacturers and MAH’s.
 EMVO refers to these clients as OBP’s.
 On-Boarding Partners.
 OBP’s have contracts with EMVO.
 OBP’s are entirely responsible for the data upload
process.
 OBP’s cannot request a direct connection to the Hub
for use by others.
47

48. Paul Mills, 19th Oct 2016, securMed
Relationship between OBP and EMVO
48
Marketing Authorization Holders (MAH)
EMVO
EU Hub
OBP
Client
Production 1 Production 2
Marketing Authorisation
Holder A
Marketing Authorisation
Holder B
Production 3 (CMO)
Marketing Authorisation
Holder C
Collects data
from

49. Paul Mills, 19th Oct 2016, securMed 49
1) Participation
Request
•Initial Contact
•Portal registration
•Non-Disclosure Agreement
2) Legitimacy
Check
•Level 1 checks
•Person checks
•(more detailed checks
if necessary)
3) Contractual/
Commercial On-
boarding
•Registration fee payment
•Connection Request
•Participation Agreement
4) Technical On-
boarding
•System Connection
•System Testing
•System Operation
Managed and
administered
by the EMVO’s
Commercial
and
Partnership
Management
Team
Managed by
the EMVO’s
Operations
Team &
Solidsoft Reply
Managed by
EMVO
and supported
by IMS*
NDA
CAR
PA
CRF
Ticket

50. Paul Mills, 19th Oct 2016, securMed
Purpose and Context
The European Hub is the central element of the European Medicines
Verification System infrastructure required by the EU-FMD.
It is to the European Hub that the data that forms the critical element of the
point-of-dispense verification concept is uploaded, namely:
 For every Medicinal Product: Product master data
 For each individual sales pack of medicines: Unique Identifier
Any incorrect or fraudulent data uploaded will severely affect the medicines
verification process and seriously undermine the trust in the system and
Europe-wide process.
It is therefore critical that:
 the access to the European Hub for the upload of these critical data is
tightly controlled and that
 the Legitimacy of any party requesting access to the European Hub is
established through a rigorously administered process.
50

51. Paul Mills, 19th Oct 2016, securMed
Checks for legitimacy
1. Is the organisation requesting access an established and legitimate
business?
2. Is the organisation requesting access a pharmaceutical
“manufacturer” as defined for EMVO purposes that is entitled to
access the European Hub?
3. Is the person making the access request entitled to make this
request on behalf of the organisation?
4. Is the request a duplicate (i.e. an organisation already covered or
registered for example duplicate request? Erroneous request by
subsidiary of a registered parent/group organisation)?
5. Are there any other causes for concern about giving this
organisation access?
51

52. Paul Mills, 19th Oct 2016, securMed
Legitimacy Check Process steps
Information
received
through Portal
(CAR form)
Level 1
checks by 3rd
party
Level 2
checks by
3rd party
Proceed with
next steps of
onboarding
process
STOP
Onboard
ing
process
52

53. Paul Mills, 19th Oct 2016, securMed
Overall timeline
Ad-hoc
process
•Current on-boarding of early adopters
•Will need to be run through the new process
Pilot phase
•Operating the new process manually
•Piloting to ensure that the process is fully workable and deal with any
unknowns/unanticipated areas
•EMVO Portal > email to IMS > Ticket captured manually
Semi-
automatic
•Refined Process automated (where this makes sense)
•EMVO Portal > EMOV Ticketing System > IMS Ticketing System
BAU
•Business – as – Usual process
•Focus shifts from on-boarding many new organisations to change and issues
management
to Q3 2016
Q4 2016
Q2 2017
Q1 2019
53

54. Paul Mills, 19th Oct 2016, securMed
Summary / Conclusions
 EMVO is in the final stages of establishing a thorough and robust
legitimacy check process
 The process will be controlled by EMVO but will leverage what a
specialised IMS can provide
 Checks for a corporation requesting to become an OBP (On-boarding
Partner) will take a risk-based approach
 There will be an Audit Trail for each decision: Why it was taken, by
whom, when, based on what information
 Phased roll-out will commence in October 2016
 NMVO’s are expected to undertake similar processes to verify the
clients connecting with them e.g. Pharmacies and Wholesalers.
54

55. Paul Mills, 19th Oct 2016, securMed
EMVS Master Data
55
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

56. Paul Mills, 19th Oct 2016, securMed
Master Data by Market
 All the relationships reduce to
this when the data is sent from
the European Hub to each
National System
56
Product Master Data
Product code
Coding scheme
Name
Common name
Pharmaceutical form
Strength
Pack type
Pack size (Dose Count)
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

57. Paul Mills, 19th Oct 2016, securMed
Master Data Guidance
57
Common Master Data (sample sheet only shown)

58. Paul Mills, 19th Oct 2016, securMed
Questions?
Thank you.
58