Preparing for EU Exit - End User Disconnection for GB Countries


Intended Audience

Software Suppliers

Date of Change

16 November 2020

Situation

Following the formal departure of the United Kingdom (UK) from the European Union (EU) on 31st January 2020, the UK entered into a Transition Period lasting until 31st December 2020. During the Transition Period the UK remains part of the single market and consequently remain 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 until 31st December 2020.

At the end of the Transition Period, the UK becomes a third country in relation to the EU. The UK legislation relating to the FMD and associated DR will be revoked by the UK government as of 1st January 2021 for GB countries (England, Scotland, Wales, Channel Islands and Isle of Man). GB country end users (Wholesalers, Community Pharmacy, Hospitals, GPs/Health /Centres, Dispensing Doctors and In-/Out-Patient Clinics) will be disconnected from the UK Medicines Verification System at 23:00hrs on 31st Dec 2020.

Under the Northern Ireland Protocol of the EU Withdrawal Agreement the EU pharmaceutical regulatory framework, including FMD, will continue to apply in Northern Ireland and Northern Ireland end users will be unaffected by this change.

As the end user disconnections will occur during the busy Winter Period SecurMed is providing advance notice so that software suppliers and end users can prepare for the disconnection and ensure there is no impact to medicines distribution, end-user operations and medicines supply to patients.

The UK FMD Working Group for Community Pharmacy has issued an updated communication regarding the future of FMD available here: https://securmed.org.uk/nmvs-news/future-of-the-safety-features-measures-under-fmd-in-great-britain-and-northern-ireland/

Background

Software suppliers to UK end-users need to ensure their software solutions are ready when the UK MVS becomes unavailable to GB country end users from 1st January 2021.

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and all user processes, will not be adversely impacted when the UK MVS becomes unavailable and end-user credentials are withdrawn by SecurMed UK.

2. Be prepared to support your GB country end users in early January 2021.


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

DOWNLOAD PDF