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 F1UK marketing authorisation;

F2(ca)

...

(d)

an Article 126a authorisation;

(e)

a certificate of registration; or

(f)

a traditional herbal registration.

Annotations

Textual amendments

F1: Word 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)
F2: Reg. 321(5)(ca) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 127