Update on FMD for contractors

The UK FMD Working Group for Community Pharmacy has issued an update for pharmacy contractors across the UK.

Now that the UK has left the EU and the Transition Period ends on 31st December 2020, some regulatory requirements will no longer apply. However, certain EU legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol.

The ‘safety features’ elements of the EU Falsified Medicines Directive (FMD, 2011/62/EU) and Delegated Regulation (2016/161) cease to have effect in Great Britain from 31st December 2020. This means that pharmacies in England will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs. End users in Great Britain will also be disconnected automatically from the UK National Medicines Verification System (UKMVS) run by SecurMed UK from 1st January 2021.

The Medicines and Medical Devices Bill (progressing through Parliament) would enable the Government to make regulations aimed at preventing falsified medicines from entering the medicine supply chain. This could include establishing a national system based on the unique identification of individual packs. However, the Government will have to consult with industry stakeholders, including pharmacy organisations, before introducing any new Regulations.

Learn more about these developments