UK transposes Falsified Medicines Directive

Question mark tablets in blisterThe Falsified Medicines Directive (FMD) has now been transposed into UK legislation and came into effect on 20 August.

The FMD (Directive 2011/62/EU) introduces a series of measures to prevent the entry of falsified medicines and substandard raw materials into the legal supply chain, including tougher rules on the controls and inspections of producers of active pharmaceutical ingredients (APIs), strengthened record-keeping requirements for wholesale distributors, and a common EU-wide logo to identify legal online pharmacies.

The FMD also introduces a requirement for a safety or 'authenticity' feature on the outer packaging, although the specifics of this will be decided by a delegated act procedure that is not expected to deliver a verdict until next year.

A delegated act is also being drawn up on Good Manufacturing Practices for APIs, while new rules have already been introduced on imports of active substances into the EU, including a requirement for written confirmation from the competent authority of the exporting third country that API shipments meet appropriate standards.

The Directive was brought into law in the UK via the Human Medicines (Amendment) Regulations 2013. Once transposed into national law, manufacturers have three years to comply.

The Medicines and Healthcare products Regulatory Agency has just set up a dedicated FMD section on its website which provides details on the new requirements for:  brokers of finished medicinal products; importation of active substances; importing medicines for export; registration of manufacturers, importers and distributors of active substances; safety features, and sales at a distance, as well as providing background information on the legislation.

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