Notice concerning regulation 251
Published 30 March 2021
© Crown copyright 2021
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This publication is available at https://www.gov.uk/government/publications/regulation-251-of-the-human-medicines-regulations-2020/notice-concerning-regulation-251
The UK remains a member of Council of Europe and the European Pharmacopoeia following the Brexit transition.
The British Pharmacopoeia (BP) continues to reproduce European Pharmacopoeia (Ph. Eur.) text for the convenience of our customers.
The UK was a founding member of the ‘Convention on the Elaboration of a European Pharmacopoeia’ and continues to be a member of the Ph. Eur. as the UK continues to be a member of the Council of Europe in its own right.
The UK remains an active member of the European Pharmacopoeia Commission through the BP.
Compliance with the BP continues to be a mandatory requirement in the UK, including Northern Ireland. Products in the UK are expected to meet the standards published by the BP.
This requirement remains the same after the transition period in accordance with the Human Medicines Regulations (Regulation 251).
In exceptional circumstances, an EU derived marketing authorisation for a product that enters Northern Ireland via the Northern Ireland Protocol, and the UK via unfettered access, may not comply with the standard specified in the relevant BP monograph.
The Human Medicine Regulations have been amended to include a temporary exception to ensure these products can remain on the market whilst the relevant monograph is revised, if appropriate. If a revised monograph is published the exception is no longer applicable.