Paragraph 8

The manufacturer must inform the holder of the F1UK marketing authorisation of any material alteration in the premises or plant used in connection with the manufacture or assembly of the medicinal products to which the UK marketing authorisation relates or in the operations for which such premises or plant are so used, and of any change since the granting of the relevant UK marketing authorisation in respect of any person—

(a)

responsible for supervising the production operations;

(b)

responsible for quality control of the medicinal products to which the UK marketing authorisation relates;

(c)

in charge of the animals from which are derived any substance used in the production of the medicinal products to which the UK marketing authorisation relates; or

(d)

responsible for the culture of any living tissues used in the manufacture of the medicinal products to which the UK marketing authorisation relates.

Annotations

Textual amendments

F1: Word in Sch. 9 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 52(3); 2020 c. 1, Sch. 5 para. 1(1)

Notes on Schedule 9

Textual amendments

F1: Words in Sch. 9 heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 52(2); 2020 c. 1, Sch. 5 para. 1(1)