By Stéphanie De Smedt
The Falsified Medicines Directive (Directive 2011/62/EC) has introduced a verification system which constitutes a key measure to fight falsification and protect the legal supply chain of medicines in the EU. The system includes safety features and a repository which stores information on each individual pack of medicines as specified in Commission Delegated Regulation 2016/161/EU.
The new rules will become applicable on 9 February 2019 in the EU and the EEA countries. As from that date, medicines on prescription (unless explicitly exempted) will have to carry the safety features consisting of a unique identifier and an anti-tampering device. The information on the safety features will be stored in the repository system at EU and national level which is currently being developed by stakeholders.