The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004

Amendment of Part IA of the General Fees Regulations

5.—(1) Part IA of the General Fees Regulations(1) (capital fees for pre-application meetings) is amended as follows.

(2) In regulation 3A—

(a) after the definition of “EC marketing authorization” insert the following definitions—

““pharmacovigilance advice” means advice, other than scientific advice, which falls within one or more of the descriptions specified in paragraphs (a) and (b)—

(a)

the advice is in connection with an application for an EC marketing authorization, or is given with a view to a person making such an application, and relates to—

(i)

the obligations that would relate to the holder of such an authorization by virtue of Title IX of the 2001 Directive or Chapter 3 of Title II of Council Regulation (EEC) No. 2309/93, or

(ii)

a post-authorization safety study protocol,

(b)

the advice is given to the holder of a United Kingdom marketing authorization or a Community marketing authorization and relates to—

(i)

compliance with the obligations that relate to him by virtue of Title IX of the 2001 Directive or Chapter 3 of Title II of Council Regulation (EEC) No. 2309/93, or

(ii)

a post-authorization safety study protocol;

“post-authorization safety study protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of a post-authorization safety study;

“product range” means one or more medicinal products containing the same active substance in relation to which the same person holds more than one EC marketing authorization;”; and

(b) after the definition of “quality development” insert the following definition—

““regulatory advice” means advice, other than scientific advice, in relation to the requirements of the 2001 Directive or Council Regulation (EEC) No. 2309/93 and which falls within one or more of the descriptions specified in paragraphs (a) to (c)—

(a)

the advice is in connection with a change to the dates for renewal of one or more EC marketing authorizations relating to a product range pursuant to Article 24 of the 2001 Directive,

(b)

the advice is in connection with—

(i)

a referral pursuant to Article 30, 31 or 36 of the 2001 Directive, or

(ii)

the procedure referred to in Article 35(2) of the 2001 Directive,

in relation to a product range, or

(c)

the advice is given to a person with a view to him making—

(i)

an application for the variation or renewal of one or more EC marketing authorizations, or

(ii)

an application to amend the time periods for submitting Periodic Safety Update Reports under Article 104(6) of the 2001 Directive,

in relation to a product range.”.

(3) After regulation 3B, insert the following regulations—

“3BA.   Subject to regulation 19, where the licensing authority holds a meeting with the holder of a marketing authorization for the purpose of providing advice to him before the publication of advertising of a medicinal product by his undertaking on whether that advertising conforms to the requirements of Title VIII of the 2001 Directive, there shall be payable by the holder of that authorization a fee of £1,346.

3BB.— (1) Subject to regulation 19, where the licensing authority holds a meeting with a person for the purpose of providing pharmacovigilance advice to that person, there shall be payable by that person—

(a) in a case where the time taken by the licensing authority to prepare for and attend the meeting is more than six hours, a fee of £1,690,

(b) in any other case, a fee of £1,346.

(2) The time taken by the licensing authority for the purposes of paragraph (1) shall be the aggregate of times spent by each individual engaged in preparing for or attending the meeting on behalf of the authority.

3BC.   Subject to regulation 19, where the licensing authority holds a meeting with the holder of one or more marketing authorizations for the purpose of providing advice to that person on proposed changes to the labelling or the package leaflets of the medicinal products to which those authorizations relate, there shall be payable by that person a fee of £1,012.

3BD.   Subject to regulation 19, where the licensing authority holds a meeting with the holder of a marketing authorization for the purpose of providing regulatory advice to that person, there shall be payable by that person a fee of £1,346.”.

(1)

Part 1A was inserted by regulation 4(3) of S.I. 2003/625 and amended by regulation 9 of S.I. 2003/2321.