# The Human Medicines Regulations 2012, Regulation 321: Specified publications


(1) In this regulation “specified publication” means any of the following—
(a) the European Pharmacopoeia;
(b) the British Pharmacopoeia;
(c) the Cumulative List of Recommended International Nonproprietary Names;
(d) a compendium prepared and published under regulation 317; or
(e) a list of names prepared and published under regulation 318.
(2) Paragraph (3) applies if an authorisation refers to a specified publication, but not to a particular edition of the publication.
(3) Where this paragraph applies, in order to determine whether anything done at a time when the authorisation is in force is done in accordance with the authorisation, the reference to a specified publication is to be construed as a reference to the edition of the specified publication in force at that time, unless the authorisation expressly provides otherwise.
(4) In paragraph (3) the reference to the edition of a specified publication in force at a particular time is a reference to the edition of that publication in force, under whatever title, at that time.
(5) In this regulation “authorisation” means any of the following—
(a) a manufacturer's licence;
(b) a wholesale dealer's licence;
(c) a UK marketing authorisation;
(ca) ...
(d) an Article 126a authorisation;
(e) a certificate of registration; or
(f) a traditional herbal registration.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/321 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-321
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.