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 £4,451.
(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.
(5) 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; F3...
(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[F4; 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.]
Textual Amendments
F1OJ No L 169, 12.7.1993, p1. 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, p1), Directive 2000/70/EC of the European Parliament and of the Council (OJ No L 313, 13.12.2000, p22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No L 6, 10.1.2002, p50), Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ No L 284, 31.10.2003, p1) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No L 247, 21.9.2007, p21).
F2Regulation 3 has been amended by S.I. 2006/1928.
F3Word in reg. 10(5)(a) omitted (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 41(a)
F4Reg. 10(5)(c) and word inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 41(b)
Modifications etc. (not altering text)
C1Reg. 10(5) modified (31.12.2020) by S.I. 2002/618, reg. 4T(2) (as inserted by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2 and S.I. 2021/873, reg. 1(1), Sch. 1 para. 7(a)(ii)); 2020 c. 1, Sch. 5 para. 1(1))