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Please note that monographs also exist for herbal medicinal products (ie herbal monographs) which are not specifically referenced as considered outside the scope of this reply (and our content).

Regulation 251 of the Human Medicines Regulations (HMRs 2012), SI 2012/1916 deals with medicinal product compliance with standards ‘specified in certain publications’. The regulation’s reference to monographs refers to drug ‘monographs’ (ie pharmacopoeial monographs) which, although is not defined in the statute, does refer to a term of art for medicinal products. Monographs refer to a written document that contains all of the information about a specific drug, such as its uses, doses, medicinal forms, warnings/safety issues, side-effects and other information, which the British Pharmacopoeia Commission devises and the British National Formulary (BNF) will publish (see: NICE’s BNF website for a definition and monograph listings and the British Pharmacopoeia website for ‘Contribute to monograph development and improvement’) in the UK. In the EU, the European Pharmacopoeia Commission devises monographs with publication in the Official Journal of