OpenLegislation

Paragraph 18 F1

Where—

F2(a)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)

F3... an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.

Annotations

Textual amendments

F1

Sch. 8 para. 18 substituted (31.12.2020) by S.I. 2019/775, regs. 1, 50(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(b))

F2

Sch. 8 para. 18(a) 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), 137(a)(i)

F3

Words in Sch. 8 para. 18(b) 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), 137(a)(ii)