Following the European Falsified Medicines Directive, new safety measures entered into force in the EU on 9 February 2019 that guarantee the identification and authenticity of medicinal products and must be adopted by players in the medicinal distribution chain.
The European Commission adopted this Regulation that contains detailed rules on safety measures for the packaging of drugs. These rules implement a control system that assures the authenticity of medicinal products.
These safety features include the placing of a unique identifier on the packaging of a medicinal product for its identification and authentication, and using a device to verify whether a product's packaging has been tampered with.
From 9 February 2019, the date this safety Regulation entered into force, manufacturers have been required to apply the unique identifier on the packaging, and distributors (hospitals and pharmacists) have had to verify their authenticity before providing these products to patients.
In a press release, EU Commissioner for Health and Food Safety M. Andriukaitis stressed the importance of these safety features for ensuring product identification and authenticity and lauded this regulation as an example of EU cooperation on the eve of the European elections.
Belgium implemented these new rules through the Royal Decree of 3 February 2019, which amended the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use and the Royal Decree of 21 January 2009 on instructions for pharmacists.
Bruno Fonteyn
Senior Associate, Brussels
bruno.fonteyn@cms-db.com
Delphine Phan
Junior Associate, Brussels
delphine.phan@cms-db.com
