Paragraph 13

Where—

(a)

animals are used in the production of medicinal products; and

F1(b)

in the case of a product for sale or supply—

(i)

in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or

(ii)

in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

contains provisions relating to them,

the manufacturer's licence holder must arrange for the animals to be housed in such premises, and managed in such a manner, as facilitates compliance with those provisions.

Annotations

Textual amendments

F1: Sch. 4 para. 13(b) substituted (31.12.2020) by S.I. 2019/775, reg. 20(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(a))