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EU Falsified Medicines Directive -Recent Updates
Feb 2017
1
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
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)
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
Requirements for safety features
Code (‘safety feature’)
+
Tamper evidence
Unique identifier
Data-Matrix Code
Randomised serial number
Product #: 09876543210982Batch: A1C2E3G4I5Expiry: 140531S/N: 12345AZRQF1234567890
Implementation Required 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)CompleteImplementation
9 February 2016 Publication of
Delegated Regulation
July 2011Publication of
FMD
36 Mon.
20192016
Non-compliance puts supply and sales at risk
2013
Jan 2013FMD except
Safety Features implemented *Italy, Belgium,
Greece have 6 years longer for implementation
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 2019https://www.gov.uk/guidance/medicines-packaging-labelling-and-patient-information-leaflets
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 2019https://www.gov.uk/guidance/medicines-packaging-labelling-and-patient-information-leaflets
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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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
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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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
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
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
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
ManufacturerParallel
Distributor
EuropeanHub
European Principal Stakeholders developed a European Stakeholder Model
16
Common Basic Concept:Point of Dispense Verification
Required by Delegated
Acts
17
Pan-European architecture: The “National Blueprint System“ approach
National
System
PharmacyWholesaler
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
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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
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
EuropeanMedicines Verification
System (EMVS) Inte
rfac
e
Inte
rfac
e
Man
ufa
ctu
rer
Paralell
ManufacturerSystem
Parallel Distributor
System
Interface
Nat’l System
UK National Medicines Verification System
(NMVS)
Interface
Pharmacy
Inte
rfac
e
Wh
ole
sale
r
Wholesaler/ Distributor
System
Interface
Hospital
Interface
Other
CommunityPharmacy
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
EuropeanMedicines Verification
System (EMVS) Inte
rfac
e
Inte
rfac
e
Man
ufa
ctu
rer
Paralell
Manufacturer
System
Parallel Distributor
System
Interface
Nat’l System
UK Medicines Verification System
(UK MVS)
Interface
Pharmacy
Inte
rfac
e
Wh
ole
sale
r
Wholesaler/ Distributor
System
Interface
Hospital
Interface
Other
Community PhamacySystem
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 23Locations
• 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
Outline Plan on a Page
Who will have to pay ?
Pharmacists, wholesalers, …
Installations for pack verification
Marketing AuthorisationHolders
Installations for pack coding
Marketing AuthorisationHolders
Repository system (Hub & national systems)
Pharmacy Wholesaler
Pharmaceutical
ManufacturerParallel
Distributor
EuropeanHub
MAHs selling products in a Member State pay for respective national system and a share of the European Hub
25
National Full Operation Costings
National system cost estimateSep 2015 26
System cost x k€
Average of IT service providers’ offersPre-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
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
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
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
Paul Mills, 19th Oct 2016, securMed
EMVS Master Data
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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