SCHEDULE 1Marketing authorisations F7in Great BritainF8in 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 2Derogations from some of the requirements in Part 1
Parallel importsF9E113
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Parallel importsE213
1
The Secretary of State may grant a marketing authorisation in relation to a veterinary medicinal product authorised in F1a member State and imported into F2Northern Ireland from that member State in accordance with this paragraph without the data required in Part 1 if the applicant can demonstrate compliance with this paragraph.
2
If the product is for a food-producing species it must be identical to a product authorised in F3Northern Ireland.
3
Other products must be therapeutically the same as a product authorised in F4Northern Ireland unless the importer can justify any differences.
4
The member State from which it is imported must have authorised the product in accordance with Directive 2001/82/EC.
5
The applicant must be established within the Community.
6
The applicant must hold (or have a contract with the holder of) a wholesale dealer’s authorisation in F5Northern Ireland appropriate to the type of product to be imported.
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)