Notice concerning regulation 251
Published 30 March 2021
漏 Crown copyright 2021
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The UK remains a member of Council of Europe and the European Pharmacopoeia following the Brexit transition.
The continues to reproduce text for the convenience of our customers.
The UK was a founding member of the 鈥楥onvention on the Elaboration of a European Pharmacopoeia鈥� 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.鈥疨roducts 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 .
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 If a revised monograph is published the exception is no longer applicable.