SC II Names of Medicinal Substances and Preparations

This Supplementary Chapter provides information on Pharmacopoeial monograph titles, on the construction of titles for formulated preparations and on the structures and nomenclature of substances of natural or semi-synthetic origin.

Introduction

British Approved Names are devised or selected by the British Pharmacopoeia Commission and published by the Health Ministers on the recommendation of the Commission on Human Medicines. British Approved Names [BANs] are nonproprietary names established inter alia to provide suitable titles for monographs for medicinal substances in the Pharmacopoeia. The issue of a British Approved Name, however, does not imply that the substance will necessarily be included in the Pharmacopoeia. The guiding principles that are used in devising or selecting new British Approved Names are stated in the current edition of the British Approved Names book.

Where a Recommended International Nonproprietary Name [rINN] has been established by the World Health Organization, this name is now invariably adopted as the BAN and used as the title of the monograph, if any, in the Pharmacopoeia. In the past there were occasional differences between the rINN and the corresponding BAN. Many, but not all, of these differences were minor changes in spelling to accommodate normal English pronunciation and usage. Implementation of Directive 92/27/EEC, however, requires the use of rINN in the labelling of medicinal products throughout the member states of the European Community. In consequence, the relevant BANs have been modified to accord with the English version of the rINN. These changes were made by means of Supplement No. 4 to British Approved Names 1997 and were reflected, where relevant, in the titles of the monographs in the 1998 edition and subsequent editions of the Pharmacopoeia as described in section A of this chapter.

The titles of monographs for medicinal preparations combine the British Approved Name with an appropriate term for the dosage form in question as described in section B of this chapter.