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The British Pharmacopoeia is published on behalf of the Health Ministers of the United Kingdom; on the recommendation of the Commission on Human Medicines, in accordance with section 99(6) of the Medicines Act 1968, and notified in draft to the European Commission (EC) in accordance with Directive 98/34/EEC.
The quality standards of the European Pharmacopoeia apply throughout the entire life-cycle of a product, and become legally binding and mandatory on the same date in all thirty-nine (39) signatory states, which include all European Union member states. Several legal texts make the European Pharmacopoeia mandatory in Europe. [1]
Manage the Clinical Practice Research Datalink and the British Pharmacopoeia. The MHRA hosts and supports a number of expert advisory bodies, including the British Pharmacopoeia Commission, and the Commission on Human Medicine which replaced the Committee on the Safety of Medicines in 2005. [citation needed]
[2] In 1979 a new edition was published with a new title, The Pharmaceutical Codex. The Medicines Commission had recommended in 1972 that the British Pharmacopoeia should henceforth be the only compendium of official standards for medicines in the UK, and the BPC lost its status as an official book. The PSGB remained as the publishers.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
Pharmacopeial reference standards are available from various pharmacopoeias such as United States Pharmacopeia and the European Pharmacopoeia. Where pharmacopoeial tests or assays call for the use of a pharmacopoeial reference standard, only those results obtained using the specified pharmacopoeial reference standard are conclusive.
A British Approved Name (BAN) is the official, non-proprietary, or generic name given to a pharmaceutical substance, as defined in the British Pharmacopoeia (BP). [1] The BAN is also the official name used in some countries around the world, because starting in 1953, proposed new names were evaluated by a panel of experts from WHO in conjunction with the BP commission to ensure naming ...
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