EU Exit and UK MVS
Following the formal departure of the United Kingdom from the European Union on 31st January 2020, the United Kingdom entered into an Implementation Period lasting until 31st December 2020. During the Implementation Period the UK will continue to remain in the single market and consequently remain fully aligned to EU Law. This means that the Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) will continue 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 Implementation Period, the UK becomes a third country in relation to the EU. Unless a negotiated outcome provides that the EU pharmaceutical acquis applies to the UK, the UK legislation relating to the FMD and associated Delegated Regulation will be revoked by the UK government as of 1st January 2021, as UK supply chain stakeholders will no longer be able to consistently comply with the established Union-wide rules and requirements.
MAHs will need to stop uploading pack data for the UK to EMVS as of 1st January 2021. 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 the UK Government confirms an extension to the Implementation Period it is expected FMD will continue to apply in the UK for the duration of any such extension only.
SecurMed UK is awaiting guidance/ direction from the UK Government on the position in relation to Northern Ireland as the circumstances related to that province remain unclear.