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British Pharmacopoeia : ウィキペディア英語版
British Pharmacopoeia

The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom. It is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organizations involved in pharmaceutical research, development, manufacture and testing.
Pharmacopoeial standards are publicly available and legally enforceable standards of quality for medicinal products and their constituents. The British Pharmacopoeia is an important statutory component in the control of medicines which complements and assists the licensing and inspection processes of the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom. Along with the British National Formulary (BNF), it defines the UK's pharmaceutical standards.
Pharmacopoeial standards are compliance requirements; that is, they provide the means for an independent judgment as to the overall quality of an article and apply throughout the shelf-life of a product. Inclusion of a substance in a pharmacopoeia does not indicate that it is either safe or effective for the treatment of any disease.
==Legal basis==

The British Pharmacopoeia is published for 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 in accordance with Directive 98/34/EEC.
The monographs of the European Pharmacopoeia (as amended by Supplements published by the Council of Europe) are reproduced either in the British Pharmacopoeia or in the associated edition of the British Pharmacopoeia (Veterinary).
In the Pharmacopoeia certain drugs and preparations are included regardless of the existence of actual or potential patent rights. Where substances are protected by Letters Patent their inclusion in the Pharmacopoeia neither conveys, nor implies, license to manufacture.

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