EU's Counterfeits Directive - Current Information of the EU Commission regarding the Implementation

The EU Commission has released the results of the Stakeholder Workshops (Impact Assessment on the Safety Features) from 6 December 2013. Here are the results and conclusions:

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. 

The work on the delegated Regulation is ongoing. Adoption by Commission foreseen at the end of 2014 at the earliest (publication in the OJ will follow in 2015 after successful scrutiny by EP, Council and WTO.

The framework conditions with regard to technical and organisational matters have thus been clarified. Now, the pharmaceutical industry in Europe knows for which Track & Trace System (2D Barcode) it has to prepare.

Source: Official Communication of the European Commission from Frédéric Morel on behalf of Stefano Soro