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.

The Belgian repository is managed by the Belgian Medicines Verification Organisation and is already live today. With this major milestone aimed at preventing falsified medicines to enter the legal supply chain in Belgium, manufacturers can therefore already start uploading their product data in the Belgian system. In parallel, the pharmaceutical wholesalers, pharmacies and hospitals can also start connecting their systems to this verification repository and ensure to be ready by 9 February 2019. An early connection to the verification system will allow to run a longer validation period to identify potential issues and prevent disruption in the daily functioning of supply chain actors providing health care services to the patients.

All relevant stakeholders, i.e. marketing authorisation holders, manufacturers, importers and wholesalers (including parallel distributors), and persons authorised or entitled to supply medicines to the public (community and hospital pharmacies and healthcare institutions) will have to comply with these new rules. To this end, the European Commission has already published a Q&A document and also the Belgian FAMHP has published guidance documents.

More recently, together with the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the European Commission has also published a letter to stakeholders regarding the implementation of the required safety features:

  • Marketing authorisation holders (MAHs): have to make sure that medicines placed on the EU market carry appropriate safety features. They have to include the information on the safety features in the marketing authorisation application or update the existing marketing authorisation files. MAHs must also set up a cooperation with the National Medicines Verification Organisations in the Member States where they market their products so the required data can be stored in the national repositories and connect with the European Medicines Verification System for the central upload of the data.
  • Manufacturers and importers (including parallel importers): must update their production lines, be ready to place safety features on their products and upload the required data into the European repository system.
  • Wholesale distributors (including parallel distributors): in order to connect to the national repositories to verify and decommission unique identifiers, they must update their computer systems.
  • Suppliers (community and hospital pharmacies, and healthcare institutions): must be equipped with scanners to read the unique identifier and updated software to connect to the repository system.

Non-compliance with these obligations by 9 February 2018 will constitute a violation of EU law and entail sanctions according to national legislation of the EU Member States.