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

PART II capital fees for applications for licences

Product Licences

1.  Subject to paragraph 2, the fee payable under regulation 3(a) in connection with an application for a product licence of a kind described in Column 1 of the following Table shall be the fee specified in the corresponding entry in Column 2 of that Table:

Column 1	Column 2
Kind of application	Appropriate Fee
1.  Major application	1.  £8,000
2.  Complex application	2.  £4,500
3.  Standard application	3.  £2,000
4.  Simple application	4.  £500

2.  Where a major or a complex application is made by a person who is already the holder of an animal test certificate, in respect of a medicinal product containing the same active ingredient as the medicinal product in respect of which the product licence is applied for, the fee payable under regulation 3(a) in connection with that application shall be reduced by the amount of the fee paid in connection with the application for that certificate.

3.—(1) Subject to sub-paragraphs (2) and (3), where an application for a product licence consists of an application for more than one such licence each relating to a product containing the same active ingredient or combination of ingredients, the fee payable under regulation 3(a) shall be of an amount equal to the aggregate of the amounts payable under paragraph 1 in respect of a separate application for each such licence.

(2) If the application is a major application, the amount payable shall be the amount payable in respect of a major application under paragraph 1 plus–

(a) in respect of each additional product licence applied for which relates to a medicinal product of a different dosage form, the amount payable in respect of a complex application under paragraph 1; and

(b) in respect of each additional product licence applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 1.

(3) If the application is a complex application, the amount payable shall be the amount payable in respect of a complex application under paragraph 1 plus–

(a) in respect of each additional product licence applied for which relates to a medicinal product of a different dosage form, the amount payable in respect of a complex application under paragraph 1; and

(b) in respect of each additional product licence applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 1.

Manufacturers' Licences

4.—(1) The fee payable under regulation 3(a) in connection with an application for a manufacturer’s licence shall be–

(a) in a case to which sub-paragraph (2) below applies, £50; or

(b) in any other case £1,000; and

(c) in either case, if appropriate, a fee calculated in accordance with Schedule 2 in respect of any inspection made in connection with that application.

(2) This sub-paragraph applies to the case of an application for a manufacturer’s licence which is limited solely to the manufacture or assembly of–

(a) medicinal products the sale or supply of which do not require a product licence and to which Article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(1) applies; or

(b) emergency vaccines for use in poultry or other animals.

(3) For the purposes of sub-paragraph (2)(b) “emergency vaccines” means (a) no other suitable licensed vaccines are readily available for such use and (b) the vaccines are manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated.

Wholesale Dealers' Licences

5.  The fee payable under regulation 3(a) in connection with an application for a wholesale dealer’s licence shall be £650.

(1)

S.I. 1971/1450; the relevant amending instrument is S.I. 1972/1200.