Time Is Short To Prepare For New Post-Brexit UK Regulation

Off-Patent Industry Reacts To Post-Transition Period Guidance From MHRA

Guidance from the UK’s MHRA on post-Brexit arrangements relevant to the off-patent industry has been welcomed by local industry body the BGMA. However, it has warned that time is short to prepare for the end of the UK-EU transition period, with new guidance in certain areas “critical.”

Post_Brexit
Guidance has been issued on UK arrangements following the Brexit transition period • Source: Shutterstock

A raft of guidance relevant to the off-patent industry has been published by the UK’s Medicines and Healthcare Products Regulatory Agency covering arrangements that will come into force at the end of the UK’s Brexit transition period, on 1 January 2021.

While the guidance – which includes documents on licensing biosimilars, comparator products in bioequivalence studies for generics and...

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