Medicines and healthcare products guidance for the post-transition period

What does this involve?

The UK has left the EU, and the transition period following Brexit finishes at the end of 2020. This means that from 1 January 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.

MHRA will develop its own regulations for both medical devices and pharmaceuticals, both within the UK and jointly with other international regulators. Stakeholders need to get ready to follow these new rules from 1 January 2021.

To help those in the medicine and healthcare product industry prepare for these changes, MHRA has prepared guidance on relevant topics. These include:

  • Clinical trials
  • Regulating medical devices
  • Licensing
  • Importing and exporting
  • IT systems and submitting to the MHRA
  • Pharmacovigilance
  • Paediatrics

Am I eligible?

Anyone can use this service.

What does this cost?

This is a free service.

Who is this for?

Anyone who works in the medicines or healthcare products industries.

How long does this take?

It will take around 2 to 2.5 hours to read the guidance on all the topics.

Next steps

Visit the UK Government website for more information and to read the full guidance.

 

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