The Medicines (Products for Animal Use—Fees) Regulations 1998

PART IIFEES 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 a kind described in an entry in column (1) of Table A is the fee specified in the corresponding entry in column (2) of that Table;

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

(c) the fee for an application for a product licence of a kind described in an entry in column (1) of Table A is 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 an application for a type A marketing authorisation	Fee for an application for a type B marketing authorisation	Fee for an application for a product licence
Major application	£18,120	£10,000	£18,120
Complex application	£10,515	£6,000	£10,515
Standard application	£4,540	£3,000	£4,540
Abridged standard application	£3,545	—	—
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 a kind described in an entry in column (1) of Table B is 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 application for an Article 15.2 marketing authorisation
Major application	£10,515
Complex application	£4,540

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, £7,605; and

(b) where a complex application was previously made in respect of the Article 15.2 marketing authorisation, £5,975.

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 (covering 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), (3) and (4) below, where an applicant applies in one or more applications, which are all pending, for a marketing authorisation or product licence for more than one product and each product contains the same active ingredient or the same combination of active ingredients, the total of the fees payable by him shall equal the aggregate of the amounts payable under paragraph 1 in respect of separate applications for each product licence or type of authorisation.

(2) Subject to sub-paragraphs (3) and (4) below, where an applicant has made an original request (that is to say a set of one or more applications as described in sub-paragraph (1) above) and either–

(a) withdraws each application in the original request and substitutes for them a new application for one or more products containing the same active ingredients or combination of active ingredients as those in the original request, or

(b) withdraws some but not all of the applications in the original request,

then there shall be calculated in respect of the new or (as the case may be) remnant applications the total of the fees which would have been charged for them had they alone comprised the original request, and that total shall be payable in respect of the new or (as the case may be) remnant applications, but there shall be allowed against it the net total of any fees payable in respect of the original request (that is to say the total so payable less any amount of that total waived, reduced or refunded under these Regulations).

(3) Where an applicant applies in one or more major applications, which are all pending, for a marketing authorisation or product licence for more than one product and each product contains the same active ingredient or combination of active ingredients the fee payable for each major application for a marketing authorisation or product licence shall be the amount payable in respect of a major application under paragraph 1 in respect of the first major application and for each major application additional to the first–

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

(b) which relates to a product of the same dosage form but of a different strength of any active ingredient, the amount payable in respect of a standard application under paragraph 1.

(4) Where an applicant applies in one or more complex applications, which are all pending, for a marketing authorisation or product licence for more than one product and each product contains the same active ingredient or combination of active ingredients, the fee payable for each complex application for a marketing authorisation or product licence shall be the amount payable in respect of a complex application under paragraph 1 in respect of the first complex application, and for each complex application additional to the first–

(a) which relates to a product of a different dosage form, the amount payable in respect of a standard application under paragraph 1; and

(b) which relates to a product of the same dosage form but of a different strength of any active ingredient, the amount payable in respect of a simple application under paragraph 1.

(5) This paragraph applies in relation to fees which would, but for this paragraph, be payable by reference to paragraph 1, whether or not as qualified by paragraph 4.

Manufacturer’s licences

6.—(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 £2,040; 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 manufacture or assembly of–

(a) products the sale 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

7.—(1) Subject to the following provision of this paragraph, the fee for an application for a wholesale dealer’s licence is £1,185.

(2) Where an applicant for a wholesale dealer’s licence anticipates that his turnover in his first calendar year of trading will be less than £40,000, he may pay a provisional fee of £480 if his payment is accompanied by an estimate of such turnover for that year, which shall, subject to the following provisions of this paragraph, be crystallised as his final fee for his application.

(3) Following the first anniversary of the grant of a wholesale dealer’s licence, where a wholesale dealer has sent with his application for a wholesale dealer’s licence such an estimate of turnover for his first calendar year of trading, he shall, together with his payment of the annual fee payable pursuant to regulation 13(1), send a declaration certifying his turnover for his first calendar year of trading.

(4) If either a declaration, as required by sub-paragraph (3) above, is not sent or the declaration, sent in accordance with sub-paragraph (3) above, shows that the wholesale dealer’s turnover for his first calendar year of trading was £40,000 or more, the wholesale dealer shall pay the balance in accordance with regulation 17(3)(b).

(5) Where a wholesale dealer has paid the full fee specified in sub-paragraph (1) above but his turnover for his first calendar year of trading was less than £40,000, if he sends a declaration certifying that turnover, the relevant authority shall refund the excess in accordance with regulation 17(3)(a).

(6) For the purposes of this paragraph, “turnover” has the same meaning as in regulation 13, “trading” means trading as a wholesale dealer, and “balance” and “excess” both mean the difference between the sum payable under sub-paragraph (1) and the sum payable under sub-paragraph (2) above.

Animal test certificates

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

Marketing authorisation (parallel import)

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

(1)

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