Directive 2011/62/EU of the European Parliament and of the Council was adopted on June 8, 2011 setting out the legislative basis for measures to protect patients across the European Union from falsified medicines, including provisions around the application and use of safety features.
The Commission Delegated Regulation (EU) 2016/161 of 2nd October 2015, published on 9th February 2016, (supplementing Directive 2001/83/EC) sets out the measures to prevent the entry into the legal supply chain of falsified medicinal products in more detail, in particular requiring the placement of safety features consisting of a unique identifier and an anti-tampering device on the packaging of certain medicinal products for human use for the purposes of allowing their identification and authentication.
These requirements come into force on February 9, 2019, three years after the publication of the Commission Delegated Regulation: All member states without pre-existing measures are required to implement Safety Features from this date. This date is also the “go-live” for the European Medicines Verification System (EMVS) and Europe-wide Point of Dispensing Authentication (PODA) process – at that time, all products supplied for Europe need to carry defined safety features – serialisation through the addition of a unique identifier subsequently uploaded to the EMVS, and tamper evidence. The three member states with pre-existing measures (Belgium, Italy, and Greece) have been granted a 6-year extension to implement the Safety Features to 9 years after the publication of the Delegated Regulation, i.e. February 9, 2025, though Belgium has committed to adhering to the 2019 timeline.
Designed to combat counterfeiting (falsification of medicinal products), the FMD has requirements for applying a unique identifier (UI) to products at the lowest level of sale and for the storage of the UI in a centralised repository system (the EMVS). Verification of the authenticity of the product and integrity of the tamper evident feature should be carried out at the time the drug product is supplied to the public; however, wholesale distributors throughout the supply chain should additionally verify products according to a risk-based approach.