Paragraph 2A Information with the application: formatF1

England, Wales and Scotland

(1)

An application must be submitted electronically.

(2)

Subject to sub-paragraph (3), the application must be structured as a single dossier in four parts—

(a)

Part 1 (administrative information);

(b)

Part 2 (pharmaceutical quality (physicochemical, biological or microbiological) data);

(c)

Part 3 (safety documentation, including safety and residue tests);

(d)

Part 4 (efficacy documentation, including pre-clinical studies and clinical trials).

(3)

An application concerning the release of GMOs must set out the environmental risk assessment in respect of that release as a separate document, and that assessment must be presented in accordance with the following provision of the GMO Deliberate Release Regulations—

(a)

as regards England or Scotland, regulation 6;

(b)

as regards Wales, regulation 7.

Annotations

Textual amendments

F1: Sch. 1 paras. 2-2C substituted for Sch. 1 para. 2 (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 28

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)