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The Human Medicines Regulations 2012
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- UK Statutory Instruments
- 2012 No. 1916
- PART 15
- Regulation 321
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Changes over time for: Section 321
Alternative versions:
- 14/08/2012- Amendment
- 31/12/2020- Amendment
- 31/12/2020
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Specified publicationsU.K.
This section has no associated Explanatory Memorandum
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 [F1UK] marketing authorisation;
[F2(ca)an EU marketing authorisation;]
(d)an Article 126a authorisation;
(e)a certificate of registration; or
(f)a traditional herbal registration.
Textual Amendments
F1Word in reg. 321(5)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 218(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Reg. 321(5)(ca) inserted (31.12.2020) by S.I. 2019/775, reg. 218(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 178)
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