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UK Regulator Attempts To Demystify Upcoming Drug Approval Rules

 
• By Ian Schofield

New guidance from the MHRA covers the issuing of UK-wide approvals for all medicines from 2025, the conversion of Great Britain product licences to UK licences, and issues relating to the approval of generics and the use of reference and comparator products.

Businessman Looking At perplexed ways Searching For Solution.
The MHRA is still tackling post-Brexit regulatory complications • Source: Shutterstock

The UK Medicines and Healthcare products Regulatory Agency has issued new guidance for anyone who may, quite reasonably, be uncertain about what happens in 2025 when yet more post-Brexit rules on the issuing of marketing authorizations come into effect.

Among the issues addressed in the guidance are the UK’s ability to approve EU centrally authorized products (CAPs) in addition...

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