SCHEDULE 1U.K.Marketing authorisations [F1in Great Britain] [F2in Northern Ireland]

PART 2U.K.Derogations from some of the requirements in Part 1

Parallel importsE+W+S

F313.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Parallel importsN.I.

13.—(1) The Secretary of State may grant a marketing authorisation in relation to a veterinary medicinal product authorised in [F4a] member State and imported into [F5Northern 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 [F6Northern Ireland].

(3) Other products must be therapeutically the same as a product authorised in [F7Northern 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 [F8Northern Ireland] appropriate to the type of product to be imported.

(7) If re-labelling is to take place in [F9Northern Ireland] the applicant must also be (or have a contract with) the holder of a suitable manufacturing authorisation in [F9Northern Ireland].