EC Issues Draft Rules on Drug Authentication

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-18-2015 17:39


The European Commission (EC) has issued his draft regulations to detail the rules for the implementation of obligatory safety features (a unique identifier and an anti-tampering device) as part of the implementation of the European Union's (EU) Falsified Medicines Directive to prevent the entry of falsified medicines in the legal supply chain in the European Union (EU). The comment period for the draft rules is open until October 11, 2015.

Among the measures outlined in the draft regulations are a harmonized structure and content of the unique identifier as well as its carrier across the EU. The draft regulations also set up of an end-to-end”system for the verification of the authenticity of the safety features complemented by risk-based checks at the wholesaler level. The draft rules specify that in practice the safety features placed on a medicine pack by the manufacturer are systematically verified for authenticity at the end of the supply chain before that pack is dispensed to a patient (e.g., by pharmacies or hospitals). The draft rules specify that the authenticity of medicines at higher risk of falsification is additionally verified in the middle of the supply chain by wholesalers. The draft rules also specify the setting up, management, and supervision of a repositories system where legitimate unique identifiers are stored. The draft rules call for the repositories system to be set up and managed by stakeholders under the supervision of EU member states' competent authorities, and that the repositories system is to be queried in order to verify the authenticity of the medicinal product.

Source: European Commission


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