Paragraph 12A F1
In Northern Ireland, the qualified person is responsible for securing—
that each batch of medicinal products manufactured in Northern Ireland has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those products; and
in the case of medicinal products imported from a country other than an EEA State, irrespective of whether the products have been manufactured in Northern Ireland or an EEA State, that each batch has undergone—
a full qualitative analysis,
a quantitative analysis of all the active substances, and
all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to those productsF2.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
This paragraph does not apply in relation to listed NIMAR products in Northern Ireland.
Annotations
Textual amendments
- F1
Sch. 7 para. 12A inserted (31.12.2020) by S.I. 2019/775, regs. 1, 32(3)(aa) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(d)); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Sch. 7 para. 12A(1)(b): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 135(a)
- F3
Sch. 7 para. 12A(1)(c) 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), 135(b)
- F4
Sch. 7 para. 12A(2) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 26