Update to the EU Falsified Medicines Directive

05/19/2018 | Corinna Bolte

Corinna Bolte

Pharmaceutical companies should waste no time in checking whether their medicinal products have been properly – or perhaps even incorrectly – described as “requiring serialisation” by the BfArM, the German authority for medicinal products. The EU Falsified Medicines Directive applies to most medicinal products, but particularly to prescription medicinal products. However, non-prescription medicinal products may also fall under its scope of application.

From February 2019, all packaging for certain medicinal products must carry a verifiable unique identifier in order to prevent falsified medicinal products entering the legal supply chain, Diapharm reported (in German).
Directive 2011/62/EU and the Delegated Regulation (EU) 2016/161 govern which medicinal products are affected by this highly complex technical challenge; generally speaking, the regulations apply to all prescription medicinal products. However, prescription medicinal products that are not at risk of falsification can be excluded from the regulation, and non-prescription medicinal products can be included in the requirements.

Article 43 of the directive stipulates that the competent national authorities must provide information on request regarding which medicinal products approved in their territory are subject to the EU Falsified Medicines Directive.The Federal Institute for Drugs and Medical Devices (BfArM) has fulfilled this obligation by labelling the corresponding medicinal products as “requiring serialisation” in the AMIS Drug Information System database. As a result, the BfArM and professional associations have requested that owners of pharmaceutical businesses review this information with regard to their products and notify the BfArM if there are any discrepancies.

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