Regulation 10 Fee for advice for other purposes

(1)

Unless regulation 44 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 £4,579.

(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 Community; or

(d)

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

(4)

This regulation does not apply to a meeting for the purpose of providing only any advice specified in regulations 4 to 9.

(5)

In this regulation—

“medical device” has the same meaning as in Article 1(2)(a) of Directive 93/42/EEC;
“Directive 93/42/EEC” means Council Directive 93/42/EEC concerning medical devices ^f1;
“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 Community instrument relating to EC 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 construed in accordance with regulation 3 (sponsor of a clinical trial) of the Clinical Trials Regulations^f2;

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 EC marketing authorization, or making a variation to an EC marketing authorization, for that product or a product of that type, or

(b)

obtaining an EC design-examination certificate within the meaning of paragraph 4.3 of Annex II to Directive 93/42/EEC or an EC type-examination certificate within the meaning of paragraph 5 of Annex III to that Directive, for a medical device incorporating that product or a product of that type.

Annotations

Footnotes

f1: OJ No. L 169, 12.7.93, p.1. This Directive has been amended by Directive 2000/70/EC of the European Parliament and of the Council (OJ No. L313, 13.2.2000, p.22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No. L6, 10.1.2002, p.50) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No. L 247, 21.9.2007, p.21).
f2: Regulation 3 has been amended by S.I. 2006/1928.