Paragraph 34 Refusal of a variation of a marketing authorisation

England, Wales and Scotland

F1(1)

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

(2)

The grounds on which the Secretary of State may refuse an application for a variation of a marketing authorisation are those set out in paragraph 24 of this Schedule (refusal of a marketing authorisation).

(3)

The Secretary of State must give written reasons for refusing to grant a variation; and if—

(a)

those reasons are on the grounds of safety, quality or efficacy; and

F2(b)

the Secretary of State produced an assessment in respect of the variation under paragraph 33A(4),

the applicant may appeal to the Veterinary Products Committee.

Annotations

Textual amendments

F1: Sch. 1 para. 34(1) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 55(a)
F2: Sch. 1 para. 34(3)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 55(b)

Notes on Schedule 1

Textual amendments

F1: Words in Sch. 1 heading inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(7)(a)
F2: Words in Sch. 1 heading inserted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(a)