Communication of the EU Commission on the upcoming delegated acts

On January 31, 2014, Stefano Soro, head of the “Medicinal Products – Quality, Safety and Efficacy” unit of the Directorate General for Health and Consumers, made a statement on the content of a delegated act regarding the implementation of Directive 2011/62/EU, the so-called EU Falsified Medicines Directive (FMD). This concerned the topics of a safety feature (the so-called “unique identifier”) and the shaping and operation of the verification system. According to this statement, the impact assessment on these topics has been concluded by the Commission and the associated delegated acts will now be drafted.

The delegated acts are to include the following provisions:

  1. The composition, format and carrier of the unique identifier will be fully harmonised across the EU. The unique identifier will be placed in a 2D barcode and contain the manufacturer code, a serialisation number, a national reimbursement number (if present), the batch number and the expiry date.
  2. Medicine authenticity will be guaranteed by an end-to-end verification system supplemented by risk-based verifications by wholesale distributors. Medicines will be systematically verified before being dispensed to patients. Medicines at higher risk of falsification (returns or medicines not being distributed directly by manufacturers) will be additionally checked at wholesaler level.
  3. The repository containing the unique identifiers will be set up and managed by stakeholders. National competent authorities will be able to access and supervise the database.

As a result, the basic principles, which were of key significance for securPharm e.V. and ACS PharmaProtect GmbH from the outset, have now also been recognized by the EU Commission.

In its communication, the EU Commission made no mention as to which products are affected by the scope of the Falsified Medicines Directive and what the criteria will be for the two lists of exceptions – i.e. for the list of prescription-only medicines that need not bear the falsification-proof safety features (the so-called “white list”) and the list of over-the-counter medicines that must bear these safety features (the so-called “black list”). However, the Commission made it clear in the past that both lists will be extremely short. This means that the Commission absolutely intends to stick to its originally defined procedure based on which all prescription-only medicines will have to bear safety features and over-the-counter medicines will not be allowed to bear them.

Due to the outstanding significance of this communication for the entire project, we refer to the original English text below:

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On behalf of Stefano SORO

Dear Madam, dear Sir, At the Stakeholder's workshop held on 6 December 2013, the Commission committed to share information that could facilitate the future implementation of the upcoming delegated act on the safety features, whenever appropriate and legally possible. I take this opportunity to inform you that the impact assessment on the benefits and cost-effectiveness of the options for the technical characteristics of the unique identifier, the modalities of verification of the safety features and the repository for the unique identifiers was successfully finalised at the end of December 2013. The Commission is now proceeding with the drafting of the delegated Regulation and will propose the following cost-effective options: 

  1. The composition, format and carrier of the unique identifier will be fully harmonised across the EU. The unique identifier will be placed in a 2D barcode and contain the manufacturer code, a serialisation number, a national reimbursement number (if present), the batch number and the expiry date.
  2. Medicine authenticity will be guaranteed by an end-to-end verification system supplemented by risk-based verifications by wholesale distributors. Medicines will be systematically verified before being dispensed to patients. Medicines at higher risk of falsification (returns or medicines not being distributed directly by manufacturers) will be additionally checked at wholesaler level.
  3. The repository containing the unique identifiers will be set up and managed by stakeholders. National competent authorities will be able to access and supervise the database.

I hope this advance notification will facilitate a timely implementation of the upcoming provisions.

Kind regards, 
on behalf of Stefano SORO,
Frédérique MOREL
Secretary to the Head of Unit

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