Parallel importsE+W+S
13.—(1) The Secretary of State may grant a marketing authorisation in relation to a veterinary medicinal product authorised in another [F3country] and imported into the United Kingdom from that [F3country] 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 the United Kingdom.
(3) Other products must be therapeutically the same as a product authorised in the United Kingdom unless the importer can justify any differences.
F4(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(5) The applicant must be established within the [F5United Kingdom].
(6) The applicant must hold (or have a contract with the holder of) a wholesale dealer’s authorisation in the United Kingdom appropriate to the type of product to be imported.
(7) If re-labelling is to take place in the United Kingdom the applicant must also be (or have a contract with) the holder of a suitable manufacturing authorisation in the United Kingdom.
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F3Word in Sch. 1 para. 13(1) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(15)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F4Sch. 1 para. 13(4) omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(15)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Sch. 1 para. 13(5) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(15)(c) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
Parallel importsN.I.
13.—(1) The Secretary of State may grant a marketing authorisation in relation to a veterinary medicinal product authorised in [F6a] member State and imported into [F7Northern 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 [F8Northern Ireland].
(3) Other products must be therapeutically the same as a product authorised in [F9Northern 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 [F10Northern Ireland] appropriate to the type of product to be imported.
(7) If re-labelling is to take place in [F11Northern Ireland] the applicant must also be (or have a contract with) the holder of a suitable manufacturing authorisation in [F11Northern Ireland].
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F6Word in Sch. 1 para. 13(1) substituted (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)(d)(i)
F7Words in Sch. 1 para. 13(1) substituted (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)(d)(ii)
F8Words in Sch. 1 para. 13(2) substituted (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)(d)(ii)
F9Words in Sch. 1 para. 13(3) substituted (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)(d)(ii)
F10Words in Sch. 1 para. 13(6) substituted (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)(d)(ii)
F11Words in Sch. 1 para. 13(7) substituted (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)(d)(ii)