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The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989

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PART VIFEES FOR BATCH CONTROL TESTING DURING THE CURRENCY OF A LICENCE

14.—(1) A fee calculated in accordance with paragraph (2) shall be payable in respect of each product licence held, in which, as a condition of that licence there is a requirement that the licence holder shall submit for testing samples of each batch of the medicinal product which he has manufactured.

(2) During any licence year the fees referred to in paragraph (1) shall be–

(a)for the first sample and up to and including three samples, a fee of £600, payable by the licence holder at the time the first sample is submitted for testing;

(b)for four samples and up to and including ten samples, an additional fee of £200, payable by the licence holder at the time the fourth sample is submitted for testing;

(c)for ten samples or more, a further additional fee of £200 payable by the licence holder at the time the tenth sample is submitted for testing.

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