The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007

Amendment of Part IA of the Medicines Fees Regulations

4.—(1) Part IA of the Medicines Fees Regulations (capital fees for pre-application meetings)(1) shall be amended as follows.

(2) In regulation 3A, in the definition of “pharmacovigilance advice”—

(a) in paragraph (a)—

(i) at the end of sub-paragraph (i), omit “or”, and

(ii) after sub-paragraph (i) insert the following sub-paragraph—

“(ia) the pharmacovigilance and risk-management systems that the applicant would be required to introduce in accordance with Article 8(3)(ia) of the 2001 Directive;”; and

(b) in paragraph (b)—

(i) at the end of sub-paragraph (i), omit “or”, and

(ii) after sub-paragraph (i) insert the following sub-paragraph—

“(ia) the pharmacovigilance and risk-management systems that he has introduced in accordance with Article 8(3)(ia) of the 2001 Directive;”.

(3) In regulation 3B, for paragraph (b) substitute the following paragraphs—

“(b) if the advice provided at that meeting consists of advice in connection with clinical development only, a fee of £2,648;

(bb) if the advice provided at that meeting consists of advice in connection with quality and safety development only, a fee of £2,934;”.

(4) After regulation 3BD, insert the following regulation—

“3BE.— (1) Where the licensing authority holds a meeting with 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 such 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),

for the purpose of providing the advice specified in paragraph (2), there shall be payable by that person a fee of £4,335.

(2) The advice referred to in paragraph (1) is 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 risks 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.

(3) This regulation does not apply to a meeting for the purpose of providing only any advice specified in regulations 3B to 3BD.

(4) In this regulation—

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

(b) “Directive 93/42/EEC” means Council Directive 93/42/EEC concerning medical devices(2) as amended by Directive 200/70/EC of the European Parliament and of the Council amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivatives of human blood or human plasma(3);

(c) “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;

(d) “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;

(e) “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;

(f) “sponsor” shall be construed in accordance with regulation 3 of the Medicines for Human Use (Clinical Trials) Regulations 2004(4); and

(g) a reference to the development of a medicinal product or a type of medicinal product is a reference to development for the purposes of—

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

(ii) 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.”.

(5) In regulation 3C, for “regulation 3B” substitute “regulations 3B to 3BE”.

(1)

Part IA was inserted by S.I. 2003/625 and amended by S.I. 2003/2321, 2004/666, 2005/2979 and 2006/494.

(2)

OJ No. L169, 12.7.93, p.1; there are other amendments to the Directive but none are relevant.

(3)

OJ No. L313, 13.2.2000, p.22.

(4)

S.I. 2004/2011; the relevant amending instrument is S.I. 2006/1928.