# The Medicines (Products for Human Use) (Fees) Regulations 2012, Regulation 10: Fee for advice for other purposes


(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;
“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;
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.

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Source: https://www.legislation.gov.uk/nisr/2012/134/regulation/10 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-10
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.