The Medicines (Products for Human Use) (Fees) Regulations 2012

PART 2 Capital Fees for Pre-Application Meetings

Interpretation of Part 2

3.  In this Part—

“EU marketing authorization” means—

(a)

a United Kingdom marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations;

(b)

a marketing authorization granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive; or

(c)

a European Union marketing authorization; and

“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply.

Fee for scientific advice: application for, or variation to, EU marketing authorization

4.  Unless regulation 5 applies, the fee payable by a person with whom the licensing authority holds a meeting in order to provide scientific advice with a view to that person making an application for an EU marketing authorization or an application for the variation of an EU marketing authorization, is—

(a) £2,378, if the advice provided at that meeting consists of advice in connection with—

(i) quality development only; or

(ii) safety development only;

(b) £2,986, if the advice provided at that meeting consists only of advice in connection with clinical development;

(c) £3,309, if the advice provided at that meeting consists only of advice in connection with quality and safety development;

(d) £3,917, if the advice provided at that meeting consists of advice in connection with—

(i) quality and clinical development; or

(ii) safety and clinical development;

(e) £4,849, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.

Fee for scientific advice: classification of a medicinal product

5.—(1) The fee payable by a person with whom the licensing authority holds a meeting to provide scientific advice in connection with the classification of a relevant medicinal product, is—

(a) £2,986, if the advice relates to a product which, if reclassified, will be available on general sale; and

(b) £3,917, if the advice relates to a product which, if reclassified, will be available without a prescription from a pharmacy.

(2) For the purposes of this regulation, a product is on general sale if it is a medicinal product of a description or falling within a class specified in an Order made under section 51 (general sale lists) of the Act(1).

Fee for advertising advice

6.  The fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide advice before the publication of advertising of a medicinal product by that holder’s undertaking on whether that advertising conforms to the requirements of Title VIII of the 2001 Directive, is £2,378.

Fee for pharmacovigilance advice

7.—(1) The fee payable by a person with whom the licensing authority holds a meeting in order to provide pharmacovigilance advice is—

(a) £3,917, in a case where the time taken by the licensing authority to prepare for and attend the meeting is more than six hours;

(b) £3,308, in any other case.

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

Fee for advice on labelling or leaflets

8.  The fee payable by the holder of one or more marketing authorizations with whom the licensing authority holds a meeting in order to provide advice on proposed changes to the labelling or the package leaflets of the medicinal products to which those authorizations relate, is £2,378.

Fee for regulatory advice

9.  The fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide regulatory advice to that person, is £2,986.

Fee for advice for other purposes

10.—(1) Unless paragraph (4) applies, the fee payable by a person specified in paragraph (2) with whom the licensing authority holds a meeting for a purpose specified in paragraph (3) is £4,810.

(2) A person who—

(a) is, or is to be, a sponsor of a clinical trial;

(b) manufactures medicinal products;

(c) is, or is to be, responsible for placing medicinal products on the market; or

(d) acts on behalf of, or provides advice or assistance to, a person referred to in sub-paragraphs (a) to (c),

is a specified person for the purpose of paragraph (1).

(3) A meeting referred to in paragraph (1) is for a specified purpose if it is held to provide advice in relation to—

(a) scientific or regulatory issues relating to the development of a medicinal product or a type of medicinal product;

(b) the design of pharmaceutical or pre-clinical tests, or clinical trials, for a medicinal product or a type of medicinal product;

(c) the management of risk in relation to a medicinal product or a type of medicinal product which is under development, or is being marketed in the European Union; or

(d) other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EU marketing authorization has been granted for that product or a product of that type.

(4) Paragraph (1) does not apply in the case of a meeting where the purpose of such a meeting is to provide only advice specified in regulations 4 to 9.

(5) In this regulation—

“Directive 93/42/EEC” means Council Directive 93/42/EEC concerning medical devices(2);

“medical device” has the same meaning as in Article 1(2)(a) of Directive 93/42/EEC;

“medicinal product” includes a substance incorporated in a medical device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive;

“regulatory issues” means issues relating to the application of any EU instrument relating to EU marketing authorizations or to medical devices, or any enactment which implements such an instrument;

“risks” means any risk relating to the quality, safety or efficacy of a medicinal product as regards patients’ health or public health, or any risk of undesirable effects on the environment;

“sponsor” shall be interpreted in accordance with regulation 3 (sponsor of a clinical trial) of the Clinical Trials Regulations(3);

and a reference to the development of a medicinal product or a type of medicinal product is a reference to development for the purposes of—

(a) obtaining an EU marketing authorization, or making a variation to an EU marketing authorization, for that product or a product of that type; or

(b) obtaining a design-examination certificate of the type mentioned in paragraph 4.3 of Annex II to Directive 93/42/EEC or a type-examination certificate of the type mentioned in paragraph 5 of Annex III to that Directive, for a medical device incorporating that product or a product of that type.

Time for payment of fees under regulations 4 to 10

11.  All sums payable by way of fees under regulations 4 to 10 must be paid within a period of 14 days, commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.

(1)

Amendments have been made to section 51 by S.I. 2006/2407.

(2)

OJ No. L 169, 12.7.1993, p.1. This Directive has been amended by Directive 98/79/EC of the European Parliament and of the Council (OJ No. L 331, 7.12.1998, p.1), Directive 2000/70/EC of the European Parliament and of the Council (OJ No. L 313, 13.12.2000, p.22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No. L 6, 10.1.2002, p.50), Regulation (EC) No. 1882/2003 of the European Parliament and of the Council (OJ No. L 284, 31.10.2003, p.1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No. L 247, 21.9.2007, p.21).

(3)

Regulation 3 has been amended by S.I. 2006/1928.