The UK Government has issued information regarding what medical product businesses should do in the event of a no-deal Brexit.
A notice has been issued to inform Medicines and Healthcare products Regulatory Agency (MHRA) stakeholders about what they will need to do in order to submit regulatory information to the government in what is claimed to be “the unlikely event of a no-deal scenario”.
The UK is currently part of the EU regulatory networks for medicines and medical devices, which have shared processes and systems such as the European Databank on Medical Devices (EUDAMED).
If there is no deal reached by 29 March 2019, the UK will no longer be part of the EU medicines and medical devices regulatory networks, meaning the sharing of these common systems and exchanges of data between the UK and EU/EEA countries would stop.
The government says the UK would then need to have its own processes and systems to manage the country’s human medicines and devices regulatory activities. It is currently developing new systems that it aims to have ready by March next year. Communications and guidance on the new processes and systems are intended to be given ahead of time to allow companies to use them from day one.
The government also requires some stakeholders to test these systems and will provide training where necessary. Companies which would need to change their own systems to work the new portals will be provided with notice and guidance later in this year should a no-deal Brexit look likely.
MHRA stakeholders would need to submit regulatory information relating to human medicines and devices directly to the UK government through a selection of national portals. The types of information that would need to be submitted can be found on the government’s website and includes device registration, periodic safety update reports, paediatric investigation plans and clinical trial applications.
If companies wish to submit product applications regarding both EU and UK markets then they would need to do this separately via the EU systems and then the UK portals.
UK companies should be able to continue interacting with the EU regulatory network according to EMA guidance and EU guidance.
The government says it wants to minimise any negative impact for stakeholders, where possible. Further information and instructions are expected to be published in the coming months and this current notice is said to be for guidance only as the government still expects to negotiate a deal with the EU.
Companies based in Ireland may need to seek other guidelines as the Irish government will discuss arrangements in the event of no deal with the European Commission and EU Member States.