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The Falsified Medicines Directive (FMD) is EU legislation which aims to increase the security of the manufacturing and distribution of medicines across Europe and protect patients and prevent falsified medicines from entering the supply chain. 

Enforcement of FMD in Member States is the responsibility of national competent authorities. Sanctions introduced in the UK can be found in the Government Response to – A Consultation on implementing ‘safety features’ under the Falsified Medicines Directive.

The consultation and impact assessment have now been published and can be viewed.

The EU Delegated Regulation 2016/161 makes it clear that the costs of establishing the repositories system (i.e. the European and national verification systems and their governing bodies) is to be borne by manufacturers (i.e. research-based companies, generic manufacturers and parallel traders).

Community and hospital pharmacies and wholesalers will be required to pay for any “physical scanning equipment” that is required for reading unique identifiers Article 32. They will also need the software required to connect with their national verification system.


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