Finalised text of Falsified Medicine Directive published

The finalised text of the EU's Falsified Medicine Directive was published by the European Commission on July 1 in anticipation of the new legislation coming into force on January 2, 2013.

The FMD incorporates a series of initiatives to help safeguard the supply chain and protect patients, including measures to regulate Internet sales of medicines and strengthen record-keeping requirements.

It includes strengthened control and inspection of facilities making active pharmaceutical ingredients (APIs) and greater oversight of for brokers, manufacturers, importers and wholesalers of medicines, as well as an EU-wide trust mark scheme for online pharmacies.

One facet of the legislation is the introduction of an obligatory unique identifier/authenticity feature for medicine packs - with the details to be determined via a delegated act. A concept paper on the safety feature element of the legislation was published in April, and has attracted around 70 comments from interested parties.

Links to the comments can be found here.