Falsified Medicines Directive (FMD)


Falsified Medicines Directive (FMD)

Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. Falsified medicines might contain ingredients, including active ingredients, which are of bad quality or in the wrong dose – either too high or too low. As they have not been properly evaluated to check their quality, safety and efficacy – as required by strict EU authorisation procedures – this could be detrimental to patients’ health.

On 02 January 2013, in order to combat the ever increasing risk that falsified medicines reach patients, the “Falsified Medicines Directive”  Directive 2011/62/EC which aims to prevent the entry into the legal supply chain of falsified medicinal products came into force.

On 02 October 2015, the Commission Delegated Regulation (EU) 2016/161 supplemented Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for new safety features to appear on the packaging of medicinal products intended for human use.

The UK’s database will be developed by a new organisation, SecurMed UK, which comprises of all the main supply chain bodies representing manufacturers, wholesalers and pharmacies. Pharmacy is represented jointly by the NPA and CCA and Raj Patel of the NPA is currently the “dispensing entities” Director of SecurMed UK.

From 9 February 2019, the Regulation applies in England.