Regulation 341 Decisions under these Regulations

(1)

Where the licensing authority notifies a person of a decision under these Regulations, it must—

(a)

state its reasons for the decision; and

(b)

inform the person of any action the person may take under these Regulations to challenge that decision and of the time for taking that action.

(2)

Paragraph (1) is without prejudice to any other provision of these Regulations concerning notification by the licensing authority.

(3)

The licensing authority must publicise any decision under these Regulations to which paragraph (4) applies in such manner as it thinks fit.

(4)

Those decisions are—

(a)

a decision to grant or revoke a F1UK marketing authorisation;

F2(aa)

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

(b)

a decision to grant or revoke a certificate of registration; and

(c)

a decision to grant or revoke a traditional herbal registration.

Annotations

F1: Word in reg. 341(4)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 224(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 184)
F2: Reg. 341(4)(aa) 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), 130