This document discusses the Falsified Medicines Directive (FMD) in the European Union. It provides details on the following key points: 1. The FMD requires medicines at risk of falsification to have unique codes and tamper-evident packaging to enable verification of authenticity. 2. Implementation requirements are being determined through Delegated Acts, which will specify uniform rules across all EU member states. 3. The Delegated Acts are expected to be adopted in August 2015 and published by the end of 2015, giving member states three years to implement safety features and authentication systems.

1. ISO/IEC 27001:2005
Certificate No: IS 567140
The Falsified Medicine Directive:
beyond nations, the latest
European news
Frankfurt
24th June 2015
1

2. Falsified Medicines
Aegate Public
2

3. Falsified Medicines Directive
 Impact Assessment completed in December 2008
 European Legislation passed in July 2011
 Required to be implemented into individual Member States
national legislation by 2nd January 2013
 Implementation in every Member State will be by the use of
a Delegated Act
 Once published in the official Journal of the EU, Member
States will have three years to implement the requirements
Aegate Public3

4. Falsified Medicines Directive
 The FMD requires medicines at risk of falsification to carry
additional safety features:-
 Unique code on each medicine pack
 Each pack to have a tamper evident device
 The safety feature will enable the systematic verification of
the authenticity of the medicine at the point of dispense
Aegate Public3

5. 1. Detailed
requirements driven
by a Delegated Act
2. All Member States
will have to
implement exactly
the same legislation
4
Delegated Acts
Aegate Public

6. Delegated Acts – what do we know
 Anti-tampering is outside the scope of the Delegated Act (DA)
 At risk medicines will carry a unique number contained within
a 2D data-matrix bar-code
 Medicines will be authenticated before they are given to the
patient
 Wholesalers will have to perform a risk-based verification
 The repository system will be managed by stakeholders
Aegate Public3

7. Delegated Acts – what do we know
 All prescriptions medicines will be included
 OTC medicines at ‘risk of falsification’ will be Included
 The Commission will create a Black List - medicines to carry
the safety features; and a White List – medicines exempt
from the safety features
 There will be a two year period when non-serialised stock in
the supply chain can be used
Aegate Public3

8. Delegated Acts – what do we know
 Parallel traders will need to ‘check-out’ medicines from the
exporting market and:-
 ‘Check-in’ medicines into the importing market
 DA are due to be adopted by end August 2015
 DA are due for publication in the Official Journal of the EU
by the end of 2015
 Once published there will be three years to implement the
safety features and install an authentication service
Aegate Public3

9. Delegated Acts – what this means for ISV’s
 Authentication will be mandatory in every European Market
 Each ISV will need to interface with an authentication
service provider
 The interface work could be considerable depending on the
service provider chosen
 Each ISV will have to do this at their own cost – unless they
choose Aegate
Aegate Public3

10. Why Aegate?
 Aegate can guarantee for each ISV:-
 Full compliance with the FMD
 A standard integration approach
 A secure service
 Full support
 A payment for the ISV’s integration activity
 Future revenue for the ISV
Aegate Public3

11. Thank you
Graham Smith
Graham.Smith@aegate.com
Watch the Aegate video:- http://www.youtube.com/watch?v=zAOG1R0jrV4
11 Aegate Public