Brexit factsheet: Regulation on medicines, medical devices and clinical trials

Find out about changes to regulations for medicines, medical devices and clinical trials if the UK leaves the EU without a deal.

Will there be any changes in regulation?

Yes. If the UK leaves the European Union the UK’s participation in EMRN (European Medicines Regulatory Network) would cease. The MHRA (Medicines and Healthcare products Regulatory Agency) would take on the functions currently undertaken by the EU for human medicines for the UK.

What does this mean for your business?

If your business has been granted a Centrally Authorised Product (CAP)* then this will automatically be transitioned to become a UK MA (Marketing Authorisation). This is process is referred to as 'grandfathering'.

The UK MHRA has written to CAP Marketing Authorisation Holders to inform them of the UK intention to grandfather Marketing Authorisations and to explain the actions that businesses need to take.

* This is a product which has achieved a marketing authorisation across the European Union.

What actions are required?

Businesses will need to provide guidance on data requirements related to grandfathering.

Marketing Authorisation Holders will have one year from exit day to provide MHRA with baseline data for CAPs that are converted into UK MAs.

MHRA will accept a 'basic' baseline data set initially to enable variations and other post-authorisation submissions to be processed. The full baseline data requirements still need to be met within one year of Brexit

If this impacts your business, you need to check that your company has received a communication.

Learn more about these regulations on GOV.UK

Are there any impacts for clinical trials?

Yes. If there's no deal, the UK’s participation in the European regulatory network for clinical trials will cease and the MHRA will take on responsibilities for the UK.

The UK will continue to recognise existing approvals - both for regulatory and ethics approvals - and there will be no need for organisations to re-apply.

Businesses, however, must consider the impact if they are involved in the supply chain for clinical trials in Europe.

Businesses should:

  • Consider their role in the supply chain
  • Check whether they have received any communications from customers
  • In the event of a no-deal Brexit, evaluate the impacts of providing services outside of the European Union

Learn more about these regulations on GOV.UK

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