PART 2Capital Fees for Pre-Application Meetings

Fee for advice for other purposes10

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 £4,451.

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 authorisation 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.

C15

In this regulation—

  • “Directive 93/42/EEC” means Council Directive 93/42/EEC concerning medical devices F1;

  • “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 authorisations 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 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 EU marketing authorisation, or making a variation to an EU marketing authorisation, for that product or a product of that type; F4...

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 typeF3; or

c

obtaining an EU technical documentation assessment certificate or EU type-examination certificate of the type mentioned in section 5 of Annex IX and section 6 of Annex X of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, for a medical device incorporating that product or a product of that type.