13/14 March 2024
Back in 2011, the European Commission (EC) published Directive 2011/62/EC, the so-called Falsified Medicines Directive (FMD).The main goal was to support the fight against counterfeit medicines. The new Directive had quite some influence on the pharmaceutical supply chain. It further introduced numerous Delegated Acts requiring certain safety features (Unique Identifier and Anti-Tampering Device), had some impact on revisions of several chapters of the EU-GMP Guidelines and led to a complete revision of the EU-GDP Guidelines.
In 2016, Commission Delegated Regulation (EU) 2016/161 was officially published, laying down detailed rules for the safety features and coming into force on 9 February 2019. GMP inspectors started looking thoroughly into the implementation during their site inspections. Now, The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the regulation.
Questions listed in the document focus for example on: