The Medicines (Products for Human Use — Fees) Regulations 1995

PART II CAPITAL FEES FOR APPLICATIONS FOR AUTHORIZATIONS, LICENCES AND CERTIFICATES

Marketing authorizations

1.—(1) Subject to paragraphs 2, 3 and 4, the fee payable under regulation 4(a) in connection with an application for a marketing authorization 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—

TABLE

Column 1	Column 2
Kind of application	Fee payable
1.  Major application (a) in respect of any such application to which Section G of Part 4 of the Annex to Council Directive 75/318/EEC(1) applies	1.—(a) £20,165
(b) which is a decentralised incoming application	1.—(b) £50,365
(c) in any other case	1.—(c) £71,950
2.  Complex application (a) which is a decentralised incoming application	2.—(a) £10,305
(b) in any other case	2.—(b) £14,725
3.  Standard application (a) which is a decentralised incoming application	3.—(a) £4,255
(b) in any other case	3.—(b) £6,080
4.  Simple application	4.  £1,710
5.  Application for a marketing authorization (parallel import)	5.  £1,700
6.  Change of ownership application	6.  £790

(2) Each reference in paragraphs 3 and 4 to an amount payable under paragraph 1 in respect of an application refers to the amount payable under that paragraph in respect of an application of the kind in question.

2.  Where a major application is made by a person who is already the holder of a clinical trial certificate in respect of a medicinal product containing the same active ingredient as the medicinal product in respect of which the marketing authorization is applied for, the fee payable under regulation 4(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) In this paragraph—

• “joint development” means the development by two or more applicants for marketing authorizations relating to medicinal products—

  (a)

  each of which contains the same new active ingredient or combination of new active ingredients but with different proprietary names and which does not require separate consideration by a committee established under section 4 (establishment of committees) of the Act or by the Medicines Commission; and

  (b)

  the development of which has been notified to the licensing authority at or before the time the application is submitted, as being a joint development undertaken by those applicants; and

  (c)

  in respect of which applications for marketing authorizations have been received by the licensing authority within one month of each other;

• “primary applicant” means —

  (a)

  that party to a joint development who first makes an application for a marketing authorization relating to a new active ingredient which was the subject of that joint development; or

  (b)

  that party to a joint development who first makes an application for a marketing authorization relating to a different dosage form or strength of that new active ingredient;

• “secondary applicant” means any party to a joint development, other than the primary applicant, who makes an application for a marketing authorization relating to the same new active ingredient as that which was the subject of the application made by the primary applicant.

(2) Subject to sub-paragraph (3), where a joint development relates to a medicinal product and two or more applications for marketing authorizations are submitted to the licensing authority by parties to the joint development, the fee payable under regulation 4(a) shall be the amount payable in respect of a major application under paragraph 1 plus—

(a) in respect of the first or only marketing authorization applied for by that secondary applicant, the amount payable in respect of a complex application under paragraph 1;

(b) in respect of each additional marketing authorization applied for by that secondary applicant which relates to a medicinal product of the same dosage form, the amount payable in respect of a standard application under paragraph 1;

(c) in respect of the first additional marketing authorization applied for by that secondary applicant relating to that medicinal product which is of a different dosage form, the amount payable in respect of a complex application under paragraph 1 and in respect of any other such application by that secondary applicant, the amount payable in respect of a standard application under paragraph 1.

(3) Where a joint development relates to a medicinal product and an application for an additional marketing authorization is submitted by both the primary applicant and the secondary applicant, both or all of which applications relate to identical dosage forms and strengths of that product—

(a) where the amount payable by the primary applicant is that in respect of a complex application, the fee payable under regulation 4(a) by the secondary applicant shall be that in respect of a standard application under paragraph 1;

(b) where the amount payable by the primary applicant is that in respect of a standard application, the fee payable under regulation 4(a) by the secondary applicant shall be that in respect of a simple application under paragraph 1.

4.—(1) Subject to sub-paragraphs (2) and (3), where an application for a marketing authorization is for more than one such authorization each relating to a medicinal product containing the same active ingredient or combination of ingredients, the fee payable under regulation 4(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 authorization.

(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 marketing authorization applied for which relates to a medicinal product of a different dosage form with a different route of administration, the amount payable in respect of a complex application under paragraph 1;

(b) in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form but with the same route of administration, the amount payable in respect of a standard application under paragraph 1; and

(c) in respect of each additional marketing authorization 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 marketing authorization applied for which relates to a medicinal product of a different dosage form with a different route of administration, the amount payable in respect of a complex application under paragraph 1;

(b) in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form but with the same route of administration, the amount payable in respect of a standard application under paragraph 1; and

(c) in respect of each additional marketing authorization 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.

Manufacturer’s licences

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

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

(b) in any other case, £1,690.

(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 medicinal products which are to be sold or supplied in circumstances to which article 2 (2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(2) applies.

Wholesale dealer’s licences

6.—(1) Subject to sub-paragraph (2), the fee payable under regulation 4(a) in connection with an application for a wholesale dealer’s licence shall be £780.

(2) The fee payable under regulation 4(a) shall be £475 where an application for a wholesale dealer’s licence—

(a) relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15% of the total turnover of the sale of authorised medicinal products carried on at that pharmacy;

(b) does not relate to anything done in a registered pharmacy but where the total turnover of the sale by way of wholesale dealing of authorised medicinal products does not exceed £30,000; or

(c) relates only to medicinal products falling within a description or class specified in an Order which is for the time being in force made under section 51(1) (general sale lists) of the Act.

(3) For the purposes of sub-paragraph (2)(a) and (b), turnover shall be calculated in accordance with the provisions of Part II of Schedule 3.

Clinical trial certificates

7.  The fee payable under regulation 4(a) in connection with an application for a clinical trial certificate shall be £14,465.

(1)

OJ No. L147, 9.6.75, p. 1. The Annex was replaced by the Annex to Council Directive 91/507/EEC (OJ No. L270, 26.9.91, p. 32).

(2)

S.I. 1971/1450.