Brexit and FMD

The United Kingdom formally departed from the European Union on 31st January 2020, entering into a Transition Period lasting until 31st December 2020.   During the Transition Period the UK continues to remain in the single market and consequently remains fully aligned to EU Law.  This means that the Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) continues to apply to all in the UK supply chain at least until 31st December 2020, as if the UK were still a member of the EU. 

At the end of the Transition Period, the UK becomes a third country in relation to the EU. Unless a negotiated UK/EU trade agreement outcome provides that the EU pharmaceutical regulatory framework applies to the UK, the UK legislation relating to FMD and associated Delegated Regulation will be withdrawn by the UK government as of 1st January 2021.   UK supply chain stakeholders would no longer be able to consistently comply with the established European Union-wide rules and requirements.      

This would mean that MAHs based in the EU would need to stop uploading pack data for the UK Medicines Verification System to EMVS as of 1st January 2021, to remain compliant with EU law.  The UK medicines regulator MHRA will provide any official guidance on whether serialisation / serialized packs can still be supplied into the UK after 1st January 2021.    

If an extension to the Transition Period is agreed between the UK Government and EU, it is expected FMD will continue to apply in the UK for the duration of that extension period only.  

SecurMed UK and our governing UK stakeholders are considering the future options required for serialisation in the UK, or parts of the UK (e.g. Northern Ireland).   We are working with EMVO on business continuity solutions for the EMVS countries in the event that the UK system needs to be disconnected from the EU-Hub.  We will communicate via our UK industry stakeholders and NCAs next steps as the outcomes of the UK/ EU negotiations become clear from the UK government. 

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The use of the term “provide for” in Article 37(d) of Commission Delegated Regulation (EU) 2016/161 means that an NMVO has to ensure that the National Competent Authorities (NCA), the EMA and the Commission are informed.

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