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

Regulations 2(1), 4(a) and 7(2)(a)

SCHEDULE 1CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES AND CERTIFICATES

PART IINTERPRETATION

1.  In this Schedule—

“active ingredient” means an ingredient of a medicinal product in respect of which efficacy is claimed (whether therapeutic, diagnostic or otherwise);

“complex application” means an application, other than a major application, for a marketing authorization where the application falls within one or more of the descriptions specified in sub-paragraphs (a) to (n)—

“decentralised incoming application” means a major application, a complex application or a standard application for a marketing authorization for a medicinal product in respect of which—

“major application” means an application relating to a medicinal product containing a new active ingredient;

“new active ingredient” means an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

“new excipient” means any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product—

“simple application” means—

“standard application” means any application for the grant of a marketing authorization which is not a major application, a complex application, a simple application, a change of ownership application or an application for a marketing authorization (parallel import).

PART IICAPITAL 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—

(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(4) 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.

PART IIICAPITAL FEES FOR APPLICATIONS FOR VARIATIONS OF AUTHORIZATIONS, LICENCES AND CERTIFICATES

Marketing authorizations

1.  In this Part of this Schedule—

“Type I Application” means an application by a marketing authorisation holder to vary a marketing authorization (not being a marketing authorization (parallel import)) which is a “minor variation” within the meaning of Article 3.1(a) of Regulation (EC) No. 541/95(5);

“Type II Application” means any application to vary a marketing authorization (not being a marketing authorization (parallel import) or a product licence of right) which is neither a Type I Application nor an application for a Type II complex variation nor a change to which Annex II to Commission Regulation (EC) 541/95 applies;

“Type II complex variation” means a variation of a marketing authorization which relates to a change—

2.  Subject to paragraphs 3 to 6 and 13 and 14, the fee payable under regulation 7(1) in connection with an application for variation of a marketing authorization shall be—

(a)where the application is a Type I Application, £190;

(b)where the application is a Type II Application, £342;

(c)where the application is for a Type II complex variation, £8,766.

3.  Where, for the purposes of Commission Regulation (EC) No. 541/95, the United Kingdom is the reference member State as defined in Article 2.2 of that Regulation, the fee payable under regulation 7(1) in connection with an application for variation of a marketing authorization shall be—

(a)where the application is a Type I Application, £230;

(b)where the application is a Type II Application, £410;

(c)where the application is for a Type II complex variation, £10,520.

4.  Subject to paragraph 5, where a marketing authorization has been granted in accordance with an application to which Section G of Part 4 of the Annex to Council Directive 75/318/EEC(6) applies, the fee in connection with the first application for variation of that marketing authorization made within 5 years of the date of the grant of that marketing authorization, so as to authorise use of the medicinal product in a new therapeutic area, shall, in addition to the fee payable under regulation 7(1), be the difference between the fee paid in connection with that application and the fee which would have been payable had the application been a major application.

5.  Paragraph 4 shall not apply where the first application for variation of the marketing authorization relates to a therapeutic area, in respect of which the applicant would be entitled (had he not already held a marketing authorization) to apply for a marketing authorization to which Section G of Part 4 of the Annex to Council Directive 75/318/EEC applies.

6.  The fee payable under regulation 7(1) in connection with an application for variation of a marketing authorization (parallel import)—

(a)where the variation applied for falls within one of the following sub-paragraphs

(i)a change of either or both of the name and the address of the holder of the authorization;

(ii)a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the authorization where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, and any change of address does not involve a change of the site of manufacture, assembly or storage or of the site from which distribution takes place;

(iii)the removal from the authorization of details of one or more of the sites of manufacture, assembly or storage or of the sites from which distribution takes place;

(iv)the removal from the authorization of details of any of the activities to which the authorization relates;

(v)the removal from the authorization of details of any of the medicinal products which the holder of the authorization is authorized to import;

shall be £95; and

(b)in any other case, shall be £310.

Manufacturer’s licences

7.  Subject to paragraphs 8 and 13, the fee payable under regulation 7(1)(b) in connection with an application for variation of a manufacturer’s licence shall be—

(a)in the case of a manufacturer’s licence referred to in paragraph 5(2) of Part II of this Schedule, £90; and

(b)in any other case, £180.

8.  The fee payable under regulation 7(1)(b) in connection with an application for variation of a manufacturer’s licence shall be £90 in respect of each variation applied for which constitutes a change to the licence not requiring an inspection or medical, scientific or pharmaceutical assessment.

Wholesale dealer’s licences

9.  Subject to paragraphs 10 and 13, the fee payable under regulation 7(1)(b) in connection with an application for a variation of a wholesale dealer’s licence shall be £210.

10.  The fee payable under regulation 7(1)(b) in connection with an application for variation of a wholesale dealer’s licence shall be £90 in respect of each variation applied for which consists of a change to the licence not requiring an inspection or medical, scientific or pharmaceutical assessment.

Clinical trial certificates

11.  Subject to paragraphs 12 and 13, the fee payable under regulation 7(1)(c) in connection with an application for variation of a clinical trial certificate shall be £240.

12.  Where an application is made for a variation to a provision of a clinical trial certificate and the variation applied for consists of no more than a change of either or both the name and address of the holder of the certificate, the fee payable under regulation 7(1)(c) shall be £90.

Identical variations

13.  Subject to paragraph 14, where more than one application by the same applicant is made at the same time for the variation of a marketing authorization, a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial certificate and where the applications are for identical variations, the fee payable under regulation 7(1)—

(a)in connection with the first application considered by the licensing authority shall be the appropriate amount specified in this Part of this Schedule:

(b)in connection with each of the other applications shall be 50% of that amount.

14.  Where more than one application for a Type II complex variation is made at the same time by the same applicant for the variation of a marketing authorization, the fee payable under regulation 7(1)

(a)in connection with the first application considered by the licensing authority shall be the appropriate amount specified in this Part of the Schedule;

(b)in connection with each of the other applications where the applications are for identical variations and in respect of which no further medical, scientific or pharmaceutical assessment is required shall be the amount which would be payable if the application was a Type II Application.