The Medicines (Products for Animal Use—Fees) Regulations 1997

PART II FEES RELATING TO APPLICATIONS FOR THE GRANT OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES

Marketing authorisations and product licences

1.  Subject to paragraphs 2, 3, 4 and 5—

(a) the fee for an application for a type A marketing authorisation of the kind described in column (1) of Table A shall be the fee specified in the corresponding entry of column (2) of that Table;

(b) the fee for an application for a type B marketing authorisation of the kind described in column (1) of Table A shall be the fee specified in the corresponding entry of column (3) of that Table; and

(c) the fee for an application for a product licence of the kind described in column (1) of Table A shall be the fee specified in the corresponding entry in column (4) of that Table.

Table A

Column (1)	Column (2)	Column (3)	Column (4)
Kind of application	Fee for a type A marketing authorisation	Fee for a type B marketing authorisation	Fee for a product licence
Major application	£15,100	£8,000	£15,100
Complex application	£8,760	£4,800	£8,760
Standard application	£3,780	£2,400	£3,780
Abridged standard application	£3,780	—	—
Simple application	£1,260	£800	£1,260
Emergency vaccine application	£40	—	£40

2.  The fee for an application for an Article 15.2 marketing authorisation of the kind described in column (1) of Table B shall be the fee specified in the corresponding entry in column (2) of that Table.

Table B

Column (1)	Column (2)
Kind of application	Fee for an Article 15.2 marketing authorisation
Major application	£8,760
Complex application	£3,780

3.  Where an application for a marketing authorisation is made by a person who is already the holder of an Article 15.2 marketing authorisation relating to the same Veterinary Medicinal Product as the marketing authorisation applied for the fee shall be—

(a) where a major application was previously made in respect of the Article 15.2 marketing authorisation, £6,340; and

(b) where a complex application was previously made in respect of the Article 15.2 marketing authorisation, £4,980.

4.  Where—

(a) 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 product containing the same active ingredient as the product in respect of which the marketing authorisation or product licence is applied for, or

(b) a major or a complex application is made by a person who is already the holder of a product licence (export only), relating to the same product as the marketing authorisation or product licence applied for,

the fee shall be reduced by the amount of the fee paid in connection with the application for that certificate or licence.

5.—(1) Subject to sub-paragraphs (2) and (3) and the original application for a marketing authorisation or product licence received at any time before grant containing the active ingredient being granted, where an application for a marketing authorisation or product licence consists of an application for more than one such product containing the same active ingredient or combination of ingredients, the fee shall be of an amount equal to the aggregate of the amounts payable under paragraph 1 in respect of separate applications for each such authorisation or licence but where an original application is withdrawn and a subsequent application for more than one such product proceeds in place of the original application, then an additional fee shall be payable on that subsequent application equal to the difference between the amount paid on that application and that payable for a major application.

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

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

(b) in respect of each additional marketing authorisation or product licence applied for which relates to a 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 simple application under paragraph 1.

Animal test certificates

6.  The fee for an application for an animal test certificate in relation to a medicinal product, other than a non-food or biological product, which is for administration to food-producing animals shall be £600, and in any other case shall be £250.

Manufacturer’s licences

7.—(1) The fee for an application for a manufacturer’s licence shall be—

(a) in a case to which sub-paragraph (2) below applies, £95; or

(b) in any other case £2,085; 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 paragraph applies in the case of an application for a manufacturer’s licence which is limited solely to the manufacturer or assembly of—

(a) products the same or supply of which do not require a marketing authorisation or product licence and to which article 2(2)(i) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(1) applies; or

(b) emergency vaccines.

Wholesale dealer’s licences

8.—(1) Subject to sub-paragraph (2) below the fee for an application for a wholesale dealer’s licence shall be £1,420.

(2) In the case of a wholesale dealer who has a turnover in respect of products of less than £40,000 the fee payable in connection with an application for a wholesale dealer’s licence, if accompanied by a declaration of turnover, shall be £480.

(3) For the purposes of paragraph 8(2), “turnover” means the gross value of all products sold by way of wholesale dealing by the applicant in the United Kingdom during the previous calendar year. Products sold by way of wholesale dealing by the marketing authorisation or licence holder shall comprise only those products in respect of which an authorisation or a licence is held during the whole or part of that calendar year.

Marketing authorisation (parallel import)

9.  The fee for an application for a marketing authorisation (parallel import) shall be £1,415.

(1)

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