SCHEDULE 1Marketing authorisations F6in Great BritainF7in Northern Ireland
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
Duties on the holder of a marketing authorisation relating to an immunological productE129
F11
Before placing an immunological product on the market the holder of the marketing authorisation must notify the Secretary of State asking for written approval to do so.
2
If notified under sub-paragraph F2(1) the Secretary of State must give or refuse a written approval as soon as is reasonably practicable.
3
No person may place an immunological product on the market without a written approval issued by the Secretary of State F3....
Duties on the holder of a marketing authorisation relating to an immunological productE229
1
Before placing an immunological product on the market the holder of the marketing authorisation must either—
a
notify the Secretary of State asking for written approval to do so; or
b
if the holder has already received written approval from F5a member State permitting the release of the product, send a copy of that approval to the Secretary of State.
2
If notified under sub-paragraph (1)(a) the Secretary of State must give or refuse a written approval as soon as is reasonably practicable.
3
No person may place an immunological product on the market without a written approval issued by the Secretary of State or (if the approval was issued by F4a member State) without sending a copy of that approval to the Secretary of State.
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)