SCHEDULE 1Marketing authorisations
PART 2Derogations from some of the requirements in Part 1
Parallel imports13
1
The Secretary of State may grant a marketing authorisation in relation to a veterinary medicinal product authorised in another member State and imported into the United Kingdom 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 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.
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 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.