Surgical Materials. Homeopathic Preparations. Volume IV. Infrared Reference Spectra. Volume V. British Pharmacopoeia Veterinary. Volume VI:. CD-ROM version. British Pharmacopoeia. British Approved Names. The site will replace pharmacopoeia. This edition also sees the introduction of a download format for use offline. This replaces the USB, and has the benefit of being updated three times per year to harmonies with the European Pharmacopoeia. Updated annually, the BP is the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products.
The BP includes almost 4, monographs which are legally enforced by the Human Medicines Regulations , and becomes legally effective on 1 January Where a pharmacopoeia monograph exists, medicinal products sold or supplied in the UK must comply with the relevant monograph.
The development of pharmacopoeia standards receives input from relevant industries, hospitals, academia, professional bodies and governmental sources, both within and outside the UK. The British Pharmacopoeia Laboratory provides analytical and technical support to the British Pharmacopoeia.
Its major functions are:. Development of new pharmacopoeia monographs: the laboratory undertakes the development and validation of qualitative and quantitative test methods for new BP monograph specifications, and refines and revalidates test methods for existing British Pharmacopoeia monographs. 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. This replaces the USB, and has the benefit of being updated three times per year to harmonis with the European Pharmacopoeia.
All monographs and requirements of the European Pharmacopoeia are also reproduced in the BP. Formulated Preparations: General Monographs. Formulated Preparations: Specific Monographs. Volume IV. Herbal Drugs, Herbal Drug Preparations and. Blood-related Products. Immunological Products. Radiopharmaceutical Preparations. Surgical Materials. Volume V. Infrared Reference Spectra. Supplementary Chapters.
Volume VI. British Pharmacopoeia Veterinary The effective date for British Pharmacopoeia monographs in this edition is I January National monographs omitted from this or earlier editions of the British Pharmacopoeia remain effective in accordance with Regulation 2 c of the Human Medicines Regulations European Pharmacopoeia monographs are identified by a chaplet of stars alongside the title.
A list of monographs included for the first time in the British Pharmacopoeia is given at the end of this introduction. It includes 37 new monographs of national origin and 25 new monographs reproduced from the 8th Edition of the European Pharmacopoeia as amended by Supplements 8.
Traditional Herbal Medicines; Homoeopathic Preparations. Work is continuing on the development of monographs for herbs used in traditional herbal medicines and homoeopathic medicines.
As stated in previous editions, the requirements for the q11aliry of the material are provided in the monograph to set the standards for Traditional Herbal Medicines in the UK and to assist the UK Traditional Herbal Medicines Registration Scheme. The British Pharmacopoeia Commission, however, has not assessed the safety and efficacy of the materials in traditional use. A significant number 14 comprising 87 technical revisions and 54 editorial revisions of national monograph have been amended by means of this edition.
For the benefit of the reader Ibis list Indicates the section, or sections, of each monograph which has been. The list of revisions appended 10 this Introduction is at comprehensive as practicable. However, to ensure that the reader uses the current standard it is essential to refer to full text of each individual monograph. Four monograph titles have been amended in this edition. The list of changes is appended at the end or this Introduction. Volumes VI Veterinary. Post a Comment.
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