Paragraph 65 Procedure for registration

United Kingdom

(1)

The procedure for registration is the same as the procedure for granting a marketing authorisation in accordance with Part 3, except—

(a)

the applicant is not required to provide proof of efficacy;

(b)

the product is not required to have a summary of product characteristics;

(c)

the Secretary of State is not required to publish an assessment report.

(2)

The procedure for variation, suspension and revocation is the same as for a marketing authorisation.

F1(3)

The Secretary of State must ensure that the procedure for granting a registration in relation to a homeopathic remedy is completed within a maximum of 210 days after the submission of the application.

Annotations

Textual amendments

F1: Sch. 1 para. 65(3) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 77

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)