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

Regulations 2(4), 3, 4, 5 8 and 12

SCHEDULE 1 FEES RELATING TO APPLICATIONS FOR THE GRANT AND THE VARIATION AND RENEWAL OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES

PART I INTERPRETATION

In this Schedule—

“application for a type A marketing authorisation” means an application for a marketing authorisation to which regulation 5(a) of the 1994 Regulations applies and “type A marketing authorisation” shall be construed accordingly;

“application for a type B marketing authorisation” means an application for a marketing authorisation to which regulation 5(b) of the 1994 Regulations applies and “type B marketing authorisation” shall be construed accordingly;

“Article 15.2 marketing authorisation” means a marketing authorisation of the type specified in Article 15.2 of Directive 81/851/EEC;

“category I application” means an application for assistance in connection with a mutual recognition application other than a category II or III application;

“category II application” means an application, other than a category III application, for assistance in connection with a mutual recognition application relating to a marketing authorisation granted in respect of a Veterinary Medicinal Product only intended for administration to animals whose flesh or products are not intended for human consumption;

“category III application” means an application for assistance in connection with a mutual recognition application relating to a marketing authorisation granted in respect of an immunological Veterinary Medicinal Product;

“food-producing animals” means animals whose flesh or products are intended for human consumption;

“type I variation—Administrative” means a variation of the type listed in paragraphs 2 and 3 of Annex I to Regulation (EC) No. 541/95(1);

“type I variation—Scientific” means a variation of the type listed in paragraphs 1 and 4 to 33 of Annex 1 to Regulation (EC) No. 51/95; and

“type II variation” means a variation of the type referred to in Article 3.1(b) of Regulation (EC) No. 541/95.

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(2) 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.

PART III FEES RELATING TO APPLICATIONS FOR ASSISTANCE IN CONNECTION WITH MUTUAL RECOGNITION APPLICATIONS

1.  Subject to paragraph 3, 4 and 5, where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table C is made within six months after the grant of the marketing authorisation to which it relates, and such application relates to an application for mutual recognition to be made to not more than five member States, the fee for such application shall be fee specified in the corresponding entry in column (2) of that Table.

2.  Where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table C is made within six months after the grant of the marketing authorisation to which it relates, and such application relates to an application of mutual recognition to be made to more than five member States, the fee for such application shall be the fee specified in the corresponding entry in column (2) of Table C, plus the additional fee specified in the corresponding entry in column (3) of that Table for the sixth and each additional member State.

3.  Where an application for assistance in connection with a mutual recognition application is made within six months after the grant of the marketing authorisation to which it relates, and an application or applications for assistance to mutually recognise such authorisation(s) has or have previously been made by the applicant, no fee shall be payable in respect of the new application if the total number of member States to which the previous application or applications and the new application relate does not exceed five.

4.—(1) Where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table C is made within six months after the grant of the marketing authorisation to which it relates, and—

(a) an application or applications for assistance mutually to recognise such authorisation has or have previously been made by the applicant; and

(b) the total number of member States to which the previous application or applications related does not exceed five but the total number of member States to which the previous application or applications related and the new application relates will exceed five,

a fee calculated in accordance with paragraph (2) shall be payable in connection with the new application.

(2) The fee payable in connection with an application to which subparagraph (1) applies shall be calculated by taking the total number of member States to which the previous application or applications related and the new application relates, deducting five from that number, and by then multiplying the resulting number by the fee specified in the corresponding entry in column (3) of Table C.

5.  Where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table C is made within six months after the grant of the marketing authorisation to which it relates, and

(a) an application or applications for assistance to mutually recognise such authorisation has or have previously been made by the applicant; and

(b) the total number of member States to which the previous application or applications related exceeds five, the fee payable in connection with the new application shall be calculated by multiplying the number of member States to which the new application relates by the fee specified in the corresponding entry in column (3) of that Table.

Table C

Column (1)	Column (2)	Column (3)
Kind of application	Basic fee	Additional Fee for the sixth and each additional member State
Major	£3,750	£700
Complex	£2,175	£336
Standard	£940	£175
Simple	£315	£60

6.—(1) Where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table D is made more than six months after the grant of the marketing authorisation to which it relates, and such application relates to an application for mutual recognition to be made to not more than five member States, the fee for such application shall be the fee specified in the corresponding entry in column (2) of Table D.

(2) Where an application for assistance in connection with a mutual recognition application of a kind described in column (1) of Table D is made more than six months after the grant of the marketing authorisation to which it relates, and such application relates to an application for mutual recognition to be made to more than five member States, the fee for such application shall be the fee specified in the corresponding entry in column (2) of Table D plus, for the sixth and each additional member State, the fee specified in the corresponding entry in column (3) of that Table.

Table D

Column (1)	Column (2)	Column (3)
Kind of application	Basic fee	Additional fee for the sixth and each additional member State
Category I application	£7,975	£1,000
Category II application	£5,320	£665
Category III application	£4,255	£530

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

Marketing authorisations (other than mutually recognised marketing authorisations) and product licences

1.  The fee for a complex application for the variation of—

(a) a marketing authorisation, other than a mutually recognised marketing authorisation, or

(b) a product licence,

shall be £2,640

2.  The fee for an application of the kind described in column (1) of Table E for the variation of—

(a) a marketing authorisation, other than a mutually recognised marketing authorisation; or

(b) a product licence,

other than a complex application shall be that specified in the corresponding entry in column (2) of that Table.

Table E

Column (1)	Column (2)
Kind of application	Fee
Variation requiring veterinary, scientific or pharmaceutical assessment	£375 for the first variation plus £155 for each additional consequential variation to other authorisations or licences in identical terms
Variation not requiring veterinary, scientific or pharmaceutical assessment	£155
Variation involving the re-issue of the licence in the new name of the company	£155
Variation where the product licence relates solely to an emergency vaccine	£40

3.  The fee for an application for the variation of a mutually recognised marketing authorisation of a kind described in column (1) of Table F shall be that specified in the corresponding entry in column (2) of that Table where the United Kingdom is acting as the reference member State and that specified in the corresponding entry in column (3) of the said Table where the United Kingdom is not acting as the reference member State—

Table F

Column (1)	Column (2)	Column (3)
Kind of application	New fee—United Kingdom acting as the reference member State	New fee—United Kingdom not acting as the reference member State
Type I variation—Administrative	£530	£100
Type I variation—scientific	£2,130	£500
Type II variation	£7,445	£2,000
New application treated as a variation	£8,510	£3,560

Manufacturer’s licences

4.  The fee for an application for variation of a manufacturer’s licence—

(a) in the case of a manufacturer’s licence referred to in paragraph 7(2) of Part II of this Schedule, shall be £95;

(b) in any other case—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £360; and

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £120.

Wholesale dealer’s licences

5.  The fee for an application for variation of a wholesale dealer’s licence—

(a) requiring veterinary, scientific or pharmaceutical assessment, shall be £360; and

(b) not requiring veterinary, scientific or pharmaceutical assessment, shall be £120.

Animal test certificates

6.  The fee for an application for the variation of an animal test certificate shall be £200.

PART V FEES RELATING TO APPLICATIONS FOR THE RENEWAL OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES AND ANIMAL TEST CERTIFICATES

Marketing authorisations and produce licences

1.  Subject to paragraph 4, the fee for an application for the renewal of a marketing authorisation of product licence that—

(a) relates solely to an emergency vaccine shall be £40,

(b) relates to a herbal product shall be £300, and

in any other case shall be £1,005.

Manufacturer’s licences

2.  The fee for an application for a renewal of a manufacturer’s licence referred to in paragraph 7(2) of Part II of this Schedule, shall be £105.

Animal test certificates

3.  The fee for an application for renewal of an animal test certificate shall be £90.

Article 15.2 marketing authorisations

4.  Where an Article 15.2 marketing authorisation is renewed, no fee shall be payable in respect of the first annual renewal.

(1)

OJ No. L55, 11.3.95, p.7.

(2)

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