The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1990

11.—(1) The fee payable for the testing of a biological medicinal product shall be determined by the category allocated to that product by the licensing authority in accordance with the provisions of this regulation. If, on consideration of the product, the licensing authority decides that it is necessary, the authority may re-allocate the product to a different category when the appropriate fee will become payable.

(2) In connection with an application for the grant of a product licence or animal test certificate the fee payable shall be that specified in paragraph (4) below opposite the appropriate category–

(a) for the testing of an emergency vaccine, category 5;

(b) for the testing of any other biological medicinal product, category 2.

(3) In respect of the batch control testing of a biological medicinal product (not being an emergency vaccine) in connection with the holding of a product licence (including a product licence of right) that product shall be allocated a category by the licensing authority according to one or more of the relevant following factors–

(a) the actual cost of the test itself;

(b) the number of batches of such a product actually submitted for testing in the previous year;

(c) the number of times such a product was actually tested in the previous year

and, subject to regulations 20 and 22, the annual fee payable on sending the first batch for testing after the date these Regulations come into force or in any subsequent licence year shall be that specified in paragraph (4) below opposite category, 1, 2, 3 or 4.

(4)	Category	Testing Fee
	Category 1	£500
	Category 2	£1,500
	Category 3	£4,000
	Category 4	£7,000
	Category 5	£50