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

The EU Commission has released the results of the Stakeholder Workshop (Impact Assessment on the Safety Features) from 28 April 2014. Here are the results and conclusions:

1. 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. This "unique identifier" will be fully harmonised across the EU which means that it has been decided upon a complete harmonisation of this "unique identifier".

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 will be additionally checked at wholesaler level. It has been agreed on the obligation of verification at wholesaler level:
- When the medicinal product is not obtained from the holder of the manufacturing authorisation or the marketing authorisation holder
- Or when products are returned by another wholesaler or a pharmacy.

3. Regarding the "repository system", the option was chosen to let the system be set up and managed by "stakeholders". In addition, supervision by "relevant competent authorities" will be established. The future system should ensure the protection of commercial, confidential and personal data. National competent authorities will be able to access and supervise the database. 

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 and Patrizia Tosetti.