Paragraph 26 Marketing authorisations in exceptional circumstances
United Kingdom
In exceptional circumstances, and if there is no other product with a full marketing authorisation for the indicated condition in the target species, the Secretary of State may grant an exceptional marketing authorisation consisting of—
a provisional marketing authorisation subject to a requirement for the applicant to provide further data F1, taking into account the benefit of the immediate availability on the market of the veterinary medicinal product in comparison to the risks; or
a limited marketing authorisation for a product with a limited market F2, taking into account the benefit in relation to public or animal health of the availability of the product on the market in comparison to the risks..
An exceptional marketing authorisation may be granted subject to such further conditions, including any restrictions, as the Secretary of State considers appropriate.
The Secretary of State must reassess each provisional or limited marketing authorisation annually.
Annotations
Textual amendments
- F1
Words in Sch. 1 para. 26(1)(a) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 47(a)
- F2
Words in Sch. 1 para. 26(1)(b) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 47(b)
- F3
Sch. 1 para. 26(1A) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 47(c)
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)