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British Pharmacopoeia 2016
The British Pharmacopoeia 2016 supersedes the British Pharmacopoeia 2015. It has been prepared by the British Pharmacopoeia Commission, with the collaboration and support of its Expert Advisory Groups, Panels of Experts and Working Parties and contains almost 4000 monographs for substances, preparations and articles used in the practice of medicine. Some of these monographs are of national origin and have been elaborated or revised under the auspices of the British Pharmacopoeia Commission whilst others (indicated to users by a chaplet of stars) have been elaborated, or revised, under the auspices of the European Pharmacopoeia Commission, supported by its Groups of Experts and Working Parties, and are reproduced from the European Pharmacopoeia. This edition, together with its companion volume, the British Pharmacopoeia (Veterinary) 2016, incorporates all the monographs of the 8th Edition of the European Pharmacopoeia, as amended by Supplements 8. I to 8.5. The user of the British Pharmacopoeia thereby benefits by finding within this comprehensively indexed compendium all current United Kingdom pharmacopoeia! standards for medicines for human use.
Volumes I and II | Medicinal Substances |
Volume III | Formulated Preparations: General Monographs Formulated Preparations: Specific Monographs |
Volume IV | Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Materials for use in the Manufacture of Homoeopathic Preparations Blood-related Products Immunological Products Radiopharmaceutical Preparations Surgical Materials |
Volume V | Infrared Reference Spectra Appendices Supplementary Chapters Index |
Volume VI | British Pharmacopoeia (Veterinary) 2020 |
The effective date for British
Pharmacopoeia monographs in this edition is I January 2016.
National monographs omitted from
this or earlier editions of the British Pharmacopoeia remain effective in
accordance with Regulation 252(2)(c) of the Human Medicines Regulations 2012.
Implementation dates regarding
European Pharmacopoeia publications are provided in Supplementary Chapter IV B:
Dates of Implementation. 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 2016 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 8.1 to 8.5.
Traditional Herbal Medicines;
Homoeopathic Preparations
Work is continuing on the
development of monographs for herbs used in traditional herbal medicines and
homoeopathic medicines. The Latin scientific names cited in BP monographs for
herbal drugs are consistent with the advice provided by the Medicinal Plant
Names Services at the Royal Botanic Gardens, Kew. 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. or these monographs, those with 111J1jor technical missions arc lis1ed al 1be end of this Introduction. For the benefit of the reader Ibis list Indicates the section, or sections, of each monograph which has been listed 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.
For those texts reproduced from
the European Pharmacopoeia, the European Oirec1orate for the Quality of
Medicines & HealthCare (EDQM) database information on revisions of the monographs
or other texts on a historical basis, beginning from the 5th Edition or the
European Pharmacopoeia.
Four monograph titles have been amended in this edition. The list of changes is appended at the end or this Introduction.
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