Paragraph 13

(1)

This paragraph applies F1in Northern Ireland where—

(a)

a medicinal product which has undergone the controls referred to in F2paragraph 12A in a member State is imported to Northern Ireland; and

(b)

each batch of the product is accompanied by control reports signed by another qualified person in respect of the medicinal product.

(2)

Where this paragraph applies, the qualified person is not responsible for carrying out the controls referred to in paragraph F312A.

Annotations

F1: Words in Sch. 7 para. 13(1) inserted (31.12.2020) by S.I. 2019/775, reg. 32(3)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(e))
F2: Words in Sch. 7 para. 13(1)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 32(3)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(e))
F3: Word in Sch. 7 para. 13(2) substituted (31.12.2020) by S.I. 2019/775, reg. 32(3)(b)(iii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(e))