ISO/IEC 27001:2005Certificate No: IS 567140

The Falsified Medicine Directive:beyond nations, the latest

European news

Frankfurt24th June 2015

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Falsified Medicines

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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

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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

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Aegate Public

1. Detailed requirements driven by a Delegated Act

2. All Member States will have to implement exactly the same legislation

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Delegated Acts

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

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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

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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

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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

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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

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Aegate Public

Thank you Graham Smith

Graham.Smith@aegate.com

Watch the Aegate video:- http://www.youtube.com/watch?v=zAOG1R0jrV4

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