Brexit | New guidance documents from MHRA

From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.

This month the UK’s medicines regulator has published two new guidance documents:

How the MHRA will manage orphan products from 1 January 2021 in Great Britain (BR) – On this guidance you will find information about the application process, market exclusivity period, paediatric indications, variation applications, fees and more.
Supplying medicines to Northern Ireland from 1 January 2021 – What you need to do to supply authorised medicines from Great Britain to Northern Ireland.

Stakeholders need to get ready for new rules.

Asphalion, an International Scientific and Regulatory Affairs Consultancy, offers regulatory solutions in the UK and can ease your path through this transition, assessing you on each step of the way. Contact us at london@asphalion.com