Paragraph 15 Similar immunological productsF1
United Kingdom
Where an immunological veterinary medicinal product is pharmacologically equivalent to a reference product other than differences in raw materials or in the manufacturing process, the results of the appropriate pre-clinical tests or clinical trials must be provided, but the applicant need not provide the results of safety tests or residue tests.
Annotations
Textual amendments
- F1
Sch. 1 para. 15 omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 40
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)