Legislation

EU legislation & guidance

Directive 2011/62/EU – Falsified Medicines Directive (FMD)  

Commission Delegated Regulation (EU) 2016/161 – sets out the detailed technical requirements for unique identifiers and the databases or ‘repositories’ where they will be stored. Also known as ‘Delegated Regulation’.

The European Commission publishes and regularly updates a Q&A on Safety Features to facilitate consistent implementation of the new safety feature requirements across Europe. This document, which is updated regularly, provides practice advice and guidance for national medicines verification organisations, marketing authorisation holders and end-users.

Irish legislation

Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013 (S.I. No. 162 of 2013) – these regulations implemented the Falsified Medicines Directive in Irish law.

Medicinal Products (Safety Features on Packaging) Regulations 2019 (S.I. No. 36 of 2019) – these regulations support the implementation of the Commission Delegated Regulation in Ireland.