The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 No. 865

Regulation 17(3) and (4) (g)

SCHEDULE 8 E+W+S The Veterinary Medicines Regulations 2013: new provisions

PART 1 E+W+S New Schedule 1A

Commencement Information

I1 Sch. 8 Pt. 1 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Regulation 4(4)

“SCHEDULE 1A E+W+S Converted 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 M1 .

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.”

Marginal Citations

M1 OJ No L 136, 30.4.2004, p 1, as last amended by Regulation (EU) No 1027/2012 (OJ No L 316, 14.11.2012, p 38).

PART 2 E+W+S Schedule 7, paragraph 15: new table

Commencement Information

I2 Sch. 8 Pt. 2 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

“Parallel imports

Application	Fee (£)
Application where the imported product is identical to [F1 a product which is authorised for sale in the United Kingdom]	2,130
Application where the imported product is therapeutically similar to [F1 a product which is authorised for sale in the United Kingdom] (can only be applied to imported products for non-food producing species)	4,710”

Textual Amendments

F1 Words in Sch. 8 Pt. 2 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(4)