FALSIFIED MEDICINES DIRECTIVE – SERIALISATION

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Falsified Medicines Directive (FMD) is the European approach to dealing with the rising global issue of falsified medicines. It involves individual serialization of medicine packs and an associated authentication system.

The Falsified Medicines Directive (FMD) 2011/62/EU was published on 1st July 2011 by the Council and Parliament of the European Union and contained measures which aim to improve the safety and security of medicine supply in Europe. Pack serialization is being introduced as a way of combatting counterfeiting and falsification and is part of the FMD which helps Finish Product Manufactures to

„ Strengthen Good Manufacturing and Good Distribution Practices

„ Improve the regulation and supervision of links in the pharmaceutical supply chain

„Ensures the integrity and authenticity of medicines – including associated safety features. The safety features include the placement of a unique identifier (UI) to allow verification of medicines throughout the supply chain and the addition of a tamper evidence device on each pack of prescriptible medicine.

The Regulation provides further technical details on the obligations of all stakeholders in the supply chain. These include the expectations on Marketing Authorization Holders to add safety features to each pack of prescriptible medicines and introduce a ‘pan-European’ verification system, which will enable those involved in the supply of medicines to verify and to determine the authenticity of that pack of medicines at the time of supply to patients. Member states have until 9th February 2019 to implement the final part, the safety features, of the Directive.

FMD will be introduced into 32 countries – the 28 (current) Member States of the EU, plus the four members of the European Free Trade Area (Iceland, Norway, Liechtenstein, Switzerland). Under FMD, Finish Product Manufacturers have to update their artworks in line with the regulations.  As this is a mandatory update, companies need to file regulatory variations.