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

Marketing authorizations

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.