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The Human Medicines Regulations 2012

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Specified publications

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321.—(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 marketing authorisation;

(d)an Article 126a authorisation;

(e)a certificate of registration; or

(f)a traditional herbal registration.

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