SCHEDULE 1Marketing authorisations F1in Great BritainF2in Northern Ireland
Annotations:
Amendments (Textual)
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)
PART 3Grant of a marketing authorisation
Marketing authorisations in exceptional circumstances26
1
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
a provisional marketing authorisation subject to a requirement for the applicant to provide further data; or
b
a limited marketing authorisation for a product with a limited market.
2
The Secretary of State must reassess each provisional or limited marketing authorisation annually.
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)