Current Information of the EU Commission regarding the Implementation

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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. A 2D barcode shall be used as "unique identifier" which will contain a code for the medicinal products manufacturer, a serialisation number, a national number for the reimbursement of costs (if applicable), the batch number and the expiry date. This "unique identifier" will be uniform throughout the EU.
2. The authenticity of the medicinal product will be ensured through an "end-to-end" verification system which will be completed by a risk-based verification through the wholesaler. Medicinal products shall be systematically verified before they are delivered to the patients. Medicinal products with high risks of counterfeiting will be additionally verified at the level of wholesalers.
3. The administration and archive location for the "unique identifier" will be established and managed by the stakeholders involved in the process. National authorities will have access to these data to be able to monitor them.
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.