The document discusses the Falsified Medicines Directive (FMD) which aims to prevent falsified medicines from entering the legal supply chain. It will require unique identifiers and anti-tampering features on prescription drug packaging and authentication checks at dispensing points. A delegated act will specify technical requirements. Stakeholders are taking action to implement interoperable national systems connected through a European hub to comply with the FMD by the 2019 deadline. Proper implementation of the FMD will create a high barrier against falsified drugs while ensuring security during technical implementation is important. All stakeholders must start preparations to meet the deadline.

1. ISO/IEC 27001:2005
Certificate No: IS 567140
The Falsified Medicine Directive
A threat or a blessing?

2. Business profile
Pharma professional with more than 40 years of experience of which
1. 17 years in local branded pharma business in sales, middle- , senior- and
general management positions
2. More than 26 years of generic pharma experience on local, European and
global level in general-,and regional management positions
3. 25 years of experience in pharma association work on local and European
level, including a 3 years EGA presidency
Emile Loof (66 years)
Career chronically
1971 Bipharma
1975 Rhone Poulenc Pharma
1987 Nycomed – general manager
1988 - 1996 Pharmachemie B.V. – SVP Marketing & Sales
1996 - 2000 Managing Director Pharmachemie B.V.
2000 – 2014 President and CEO Pharmachemie B.V.
2006 – 2014 member European Leadership Team Teva
1988 – present Secretary Dutch Generic Association
2004 - 2014 Executive of the European Generic Association (EGA)
2005 – 2007 President EGA
2014 – present Pharma consultant2

3. EGA Membership
HeGA
(Greece)
SPMA
(Slovenia)
COMPA
NIES
NATIONAL
ASSOCIATIONS
GE
(Hungary)
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4. Falsified Medicines Directive (2011/62/EU)
 Accepted by EU parliament in 2011
 The prevention of the entry of falsified medicines into the legal supply
chain for prescribed pharmaceuticals
 Applicable for prescription medicines only
 NOT applicable for OTC products ???
 NOT covering products offered on internet !!!
 ALL product-packs have to carry an unique identification
 ALL product-packs have to be tampering-proof
 Authentication of ALL products at dispensing-point
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5. Delegated Act
 A DA allows Parliament and the Council to delegate to the Commission
the power to adopt "non-legislative acts of general application to
supplement or amend certain non-essential elements of a legislative
act"
 Enacting terms:
 Technical characteristics of the Unique Identifier
 Verification of the Safety Features
 Repository for the Unique Identifier
 Procedure for notification of exceptions by Member States
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6. Impact Assessment – Outcome (I)
 Establishment and management by stakeholders with supervision by the relevant
competent authorities
 Harmonisation of the composition of the number and the data carrier to fight against
falsified, recalled and expired medicines
 The UI shall contain the following information:
 Manufacturer product code
 Serial number SECURITY!!!
 Expiry date
 Batch number
 National reimbursement number, if present
 The UI will be carried by a 2D matrix code.
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7. Impact Assessment – Outcome (II)
 Systematic verification of the safety features at the point of dispense
and risk-based verification by wholesale distributors
 Medicines will be systematically checked-out at the point of dispense
 Wholesale distributors will verify the safety features when:
 The product is not obtained from the holder of the manufacturing
authorisation or the holder of the marketing authorisation;
 The product is returned by another wholesale distributor or a
pharmacy.
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8. Impact Assessment – Outcome (in practice)
The manufacturers and parallel importers will have to ensure that:
 The unique identifier is placed on the pack for authentication;
 The serial number can be checked out at the dispensing point;
 The repository system is suitable to ensure authentication of medicinal products at
the dispensing point;
 The response from the repository system is virtually instantaneous;
 The repository system guarantees the protection of commercial, confidential and
personal data;
 The concerned competent authorities have full access to the repository system and
can supervise its functioning.
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9. Delegated Act timelines
 Mid-2015: Adoption by European Commission
 End-2015: Publication in Official Journal
 Transitional measures
 3 year transition phase (till end-2018)
 fade-out phase till expiry date of products
 6 additional years for countries with a system for verifying
authenticity (BE, IT, HE)
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10. Stakeholders take action to protect patients from falsified medicines
VISION
• Protect legal medicines supply chain throughout EU
• Comply with FMD in an effective and cost-efficient way
STATUS
• Design for Pan-European system and governance in place:
National systems connected by European Hub
• Start up implementation in place
PLAN
• Work with EU and national authorities as well as EU and national stakeholder
associations towards effective rollout
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11. Common basic concept: unique identifier
Data-Matrix code, developed to ISO-standards
Key data elements:
→ Product code (GTIN/NTIN or PPN)
→ Randomised unique serial number
→ Expiry date
→ Batch number
→ National health number (where necessary)
Product #: 09876543210982
Batch: A1C2E3G4I5
Expiry: 140531
S/N: 12345AZRQF1234567890
Expected to be required by
Delegated Acts
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12. Common basic concept: “Point of dispense verification”
Expected to be
required by
Delegated Acts
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13. Pan-European architecture: design for interoperability and efficiency
National
System
Pharmaceutical
Manufacturer
Parallel
Distributor
National
System
National
System
National
System
National
System
European
Hub
National
System
WholesalerPharmacy

14. Conclusions:
 A proper implemented FMD will definitely create a high
barrier of entry for falsified medicines to enter the legal
supply chain.
 Regarding the technical implementation of the serialisation
activities by industry : DO NOT forget the security element!
(how safe is your environment)
 To be ready for 01-01-2019 industry and all stakeholders
have to start acting now!

15. Q&A
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