Preparing for EU Exit


Intended Audience: Software Suppliers


Date of Change: 15 September 2020


Situation

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. 

The United Kingdom comprises of Great Britain and Northern Ireland.  The Great Britain countries are England, Scotland, Wales together with the Crown Dependencies of Isle of Man and Channel Islands.   These are the GB countries

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regulatory framework applies to the UK, the UK legislation relating to FMD and associated Delegated Regulation will be withdrawn by the UK government as of 1st January 2021.    GB country supply chain stakeholders will no longer be able to consistently comply with the established European Union-wide rules and requirements as a result of FMD/DR being withdrawn.    

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.  

Under the Northern Ireland Protocol of the UK/EU Withdrawal Agreement the EU pharmaceutical regulatory framework will continue to apply in Northern Ireland.   This includes FMD and Delegated Regulation.  The UK industry stakeholders are working with EMVO to ensure a UKNI Medicines Verification System is in place and connected to EMVS by 01-Jan-2021 so that FMD can continue in the UK in respect of Northern Ireland.

We will communicate via our UK industry stakeholders and NCAs more detail on the UKNI MVS as the outcomes of the UK/ EU negotiations become clear from the UK government.

 

Background
Software suppliers to UK end-users need to ensure their software solutions are ready should the UK MVS be unavailable to those users on or around 31st December 2020.

Note: This bulletin is NOT intended for Software Suppliers to MAHs and Parallel Distributors who should refer to their customers for guidance.


Recommendations
1. Software suppliers need to make sure that their systems, and all users, will not be adversely impacted if the UK MVS becomes unavailable in the event that end-user credentials are withdrawn by SecurMed UK.
2. Should credentials be withdrawn with limited / no notice, software should be prepared in such a manner that it can cater for this event with no other impact to end-user operations or other systems /processes.


If you have any questions please email help@securmed.org.uk

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