F1SCHEDULE 1AConverted EU marketing authorisations
1
In this Schedule—
“converted EU marketing authorisation” means an EU marketing authorisation to which paragraph 2 applies;
“EU marketing authorisation” means a marketing authorisation for a veterinary medicinal product granted by the European Commission in accordance with Title 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
2
This paragraph applies to an EU marketing authorisation which—
a
was granted before exit day, and
b
remains in force immediately before exit day.
3
A converted EU marketing authorisation has effect on and after exit day for the purposes of these regulations as if it were a marketing authorisation granted by the Secretary of State under these Regulations on the date it was originally granted—
a
on the terms which were in force immediately before exit day,
b
with the benefit of any periods of data marketing exclusivity from which the holder benefited immediately before exit day, and
c
subject to any suspension or post-authorisation obligations which were in force immediately before exit day.
4
Without prejudice to the generality of paragraph 3—
a
the holder of a converted EU marketing authorisation is subject to the annual fee as set out in paragraph 26 of Schedule 7;
b
a converted EU marketing authorisation is to be treated as having been granted in accordance with regulation 4(3) and Schedule 1 for the purposes of Regulation (EC) No 469/2009.
Sch. 1A inserted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(3), Sch. 8 Pt. 1; 2020 c. 1, Sch. 5 para. 1(1)