Paragraph 10A Hybrid veterinary medicinal productsF1

England, Wales and Scotland

An applicant for a marketing authorisation must provide the results of relevant pre-clinical studies or clinical trials where—

(a)

bioavailability studies are not capable of demonstrating bioequivalence between the veterinary medicinal product for which the authorisation is sought and a reference veterinary medicinal product for the purposes of paragraph 10; or

(b)

the veterinary medicinal product for which the authorisation is sought is not pharmacologically equivalent to a reference veterinary medicinal product for the purposes of paragraph 10 as a result of a difference in relation to—

(i)

the active substance or substances contained in the product;

(ii)

the strength of the product;

(iii)

the indications for use of the product;

(iv)

the pharmaceutical form of the product;

(v)

the route of administration of the product;

(vi)

the withdrawal period for the product.

Annotations

Textual amendments

F1: Sch. 1 para. 10A inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 34

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)