Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007 and shall come into force on 1st April 2007.

(2) In these Regulations, “the Medicines Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995(8).

Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

2.—(1) The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(9) are amended as follows.

(2) In regulation 14 (fees for variations of certificates)—

(a) in paragraph (2)(a), for “£226” substitute “£237”;

(b) in paragraph (2)(b)(i), for “£226” substitute “£237”;

(c) in paragraph (2)(b)(ii), for “£226” substitute “£237”;

(d) in paragraph (2)(b)(iii), for “£114” substitute “£120”; and

(e) in paragraph (2)(b)(iv), for “£57” substitute “£60”.

(3) In regulation 15 (fees payable by holders of certificates), in paragraph (1), for “£15” substitute “£19”.

(4) In the table in Schedule 2 (fees for applications for the grant of certificates of registration)(10)—

(a) in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)—

(i) for “£148” substitute “£155”,

(ii) for “£444” substitute “£466”,

(iii) in paragraph 3, for “£465” substitute “£488”, and

(iv) for “£734” substitute “£770”; and

(b) in column (3) (fees for other applications)—

(i) for “£365” substitute “£383”,

(ii) for “£654” substitute “£686”,

(iii) in paragraph 3, for “£608” substitute “£622”, and

(iv) for “£960” substitute “£1,007”.

(5) In Schedule 2A (fees for assistance in obtaining certificates of registration in other EEA States)(11), in paragraph 2—

(a) in sub-paragraph (a), for “£266” substitute “£279”; and

(b) in sub-paragraph (b), for “£348” substitute “£365”.

Amendment of Part I of the Medicines Fees Regulations

3.  In Part I of the Medicines Fees Regulation (general), in regulation 2 (interpretation)—

(a) for the definition of “the 2001 Directive” substitute the following definition—

““the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(12), as amended by—

(b) after the definition of “EEA State” insert the following definition—

““exempt imported product” means a medicinal product, as defined in Article 1(2) of the 2001 Directive, to which paragraph 1 of Schedule 1 to the 1994 Regulations(18) applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorization has been granted;”; and

(c) after the definition of “relevant fee period” substitute the following definition—

““special import notice” means a written notice given to the licensing authority in accordance with paragraph 7(2) of Schedule 2 to, or paragraph 3(2) of Schedule 4 to, the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005(19);”.

Amendment of Part IA of the Medicines Fees Regulations

4.—(1) Part IA of the Medicines Fees Regulations (capital fees for pre-application meetings)(20) 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(21) as amended by Directive 200/70/EC of the European Parliament and of the Council amending Council Diretcove 93/42/EEC as regards medical devices incorporating stable derivatives of human blood or human plasma(22);

(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(23); 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”.

Amendment of Part VI of the Medicines Fees Regulations

5.  In Part VI of the Medicines Fees Regulations (periodic fees for marketing authorizations and licences), in regulation 14A (periodic fees for clinical trial authorisations)(24)—

(a) in paragraph (1), for “paragraphs (3) to (5)” substitute “paragraphs (4) and (5)”; and

(b) omit paragraph (3).

Amendment of Part VII of the Medicines Fees Regulations

6.  In Part VII of the Medicines Fees Regulations (administration), in regulation 15 (payment of fees to Ministers), omit the words from “specified in section 1(1)(a)” to the end.

Amendment of Schedule 1 to the Medicines Fees Regulations

7.—(1) Schedule 1 to the Medicines Fees Regulations (capital fees for applications for, and variations to, marketing authorizations, licences and certificates) is amended as follows.

(2) In Part I (interpretation), in paragraph 1—

(a) in the definition of “complex application”(25)—

(i) for “sub-paragraphs (a) to (o)” substitute “sub-paragraphs (a) to (r)”, and

(ii) after paragraph (o) insert—

“(p) an application where the sole or primary evidence for the safety and efficacy of the medicinal product consists of published scientific literature;

(q) the application is—

(i) for an extension of an existing marketing authorization which fulfils the conditions set out in Annex II to Commission Regulation (EC) No. 1084/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State(26), and

(ii) includes the results of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive;

(r) the application—

(i) is not an application in accordance with Article 10, 10a or 10c of the 2001 Directive, and

(ii) includes the results of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive;”;

(b) after the definition of “EC marketing authorization”, insert the following definition—

““eCTD format” means the electronic format of the Common Technical Document referred to in the guidance published by the European Commission in Volume 2B of “The Rules Governing Medicinal Products in the European Union”, referred to in paragraph (1) of the Introduction to Annex I to the 2001 Directive(27);”; and

(c) after the definition of “major application”, insert the following definition—

““the MHRA portal” means the internet-based hosted platform which enables persons to carry out business with the Medicines and Healthcare products Regulatory Agency of the Department of Health electronically, known as the “the MHRA Portal”(28);”.

(3) In Part II (capital fees for applications for authorizations, licences and certificates), in paragraph 1, for sub-paragraph (1) substitute—

“(1) Subject to paragraphs 1A, 2, 3, 4 and 4A, the fee payable under regulation 4(a) in connection with an application for a marketing authorization of a kind described in column 1 of the following table shall be—

(a) if—

(i) the application is made using the MHRA portal, and

(ii) the particulars and documents accompanying the application are presented in eCTD format,

the fee specified in the corresponding entry in column 2 of that table; or

(b) in any other case, the fee specified in the corresponding entry in column 3 of that table.

(4) In Part III (capital fees for applications for variations of authorizations, licences and certificates)—

(a) for paragraph 2 substitute the following paragraph—

“2.  Subject to paragraphs 4 to 6 and 13 to 15, the fee payable under regulation 7(1) in connection with an application for a variation of a marketing authorization of a kind described in column 1 of the following table shall be—

(a) if—

(i) the application is made using the MHRA portal, and

(ii) the particulars and documents accompanying the application are presented in eCTD format,

the fee specified in the corresponding entry in column 2 of that table; or

(b) in any other case, the fee specified in the corresponding entry in column 3 of that table.

; and

(b) omit paragraph 3.

Amendment of Schedule 2 to the Medicines Fees Regulations

8.  In Schedule 2 to the Medicines Fees Regulations (fees for inspections)—

(a) in paragraph 1, in sub-paragraph (1), omit the definition of “exempt imported product”;

(b) in paragraph 2, omit sub-paragraph (f); and

(c) in paragraph 5—

(i) in sub-paragraph (1), omit “sub-paragraph (3) and”, and

(ii) omit sub-paragraph (3).

Amendment of Schedule 3 to the Medicines Fees Regulations

9.—(1) Part III of Schedule 3 to the Medicines Fees Regulations (periodic fees for marketing authorizations and licences) is amended as follows.

(2) In the table in paragraph 1—

(a) in column (1), at the end insert the following entry—

“(h) Homoeopathic or anthroposophic product which is the subject of a licence of right”;

(b) in column (2), at the end insert the following entry—

“2(h) £68”.

(3) In paragraph 7, after sub-paragraph (2), insert the following sub-paragraph—

“(3) The fee payable under regulation 14(3) in connection with the holding of a manufacturer’s licence which relates to the import of exempt imported products from a third country shall be the fee payable in accordance with sub-paragraph (1) and an additional amount calculated in accordance with paragraph 9B.”.

(4) In paragraph 8, in sub-paragraph (1), for “paragraph 9” substitute “paragraphs 9 and 9A”

(5) After paragraph 9, insert the following paragraphs—

“9A.  The fee payable under regulation 14(3) in connection with the holding of a wholesale dealer’s licence which relates to exempt imported products shall be the fee payable in accordance with paragraphs 8 and 9 and an additional amount calculated in accordance with paragraph 9B.

Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products

9B.—(1) The additional amount referred to in paragraphs 7(3) and 9A in relation to any fee period shall be the fee specified in the entry in column 2 of the following table corresponding to the estimated number of special import notices for that fee period specified in column 1.

(2) For the purposes of this paragraph, the estimated number of special import notices for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.”.

Amendment of Schedule 6 to the Medicines Fees Regulations

10.  In Schedule 6 to the Medicines Fees Regulations (adjustment, reduction or refund of periodic fees), after paragraph 1 insert the following paragraph—

“1A.—(1) This paragraph applies to periodic fees payable in connection with a manufacturer’s licence or a wholesale dealer’s licence which relates to exempt imported products.

(2) If during a fee period the number of special import notices given by a licence holder is greater than the estimated number notified by the licensing authority in accordance with paragraph 9B of Part III of Schedule 3, the periodic fee payable in relation to that period shall be increased by the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.

(3) If during a fee period the number of special import notices given by a licence holder is less than the estimated number notified by the licensing authority in accordance with paragraph 9B of Part III of Schedule 3, the licensing authority shall refund the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.”.

Increase in fee amounts prescribed by the Medicines Fees Regulations

11.  In each provision of the Medicines Fees Regulations specified in the entries in column (1) of the Schedule to these Regulations (the content of which is described in column (2) of that Schedule), for the amount specified opposite that provision in column (3) of that Schedule substitute the amount specified opposite that provision in column (4) of that Schedule.

Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995

12.—(1) The Medical Devices (Consultation Requirements) (Fees) Regulations 1995(29) are amended as follows.

(2) In regulation 1 (citation, commencement and interpretation), in paragraph (2)—

(a) for the definitions of “Annex II” and “Annex III” substitute the following definitions—

““Annex I”, “Annex II” and “Annex III” mean respectively Annex I, Annex II and Annex III to the Directive;”;

(b) in the definition of “competent body”, for the words from “Directive 2001/83/EC” to the end substitute “the 2001 Directive”;

(c) after the definition of “the Directive” insert the following definition—

““the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended by—

(d) omit the definition of “fee”;

(e) in the definition of “manufacturing authorisation”, for the words from “Directive 2001/83/EC” to the end substitute “the 2001 Directive”; and

(f) in the definition of “medicinal substance”, for the words from “Directive 2001/83/EC” to the end substitute “the 2001 Directive”.

(3) In regulation 2 (circumstances in which a fee is payable), in paragraph (1), after “pay a fee” insert “specified by, or determined under, regulation 3”.

(4) In regulation 3 (fees)—

(a) in paragraph (1)—

(i) in sub-paragraph (a), for “£3,948” substitute “£4,141”, and

(ii) in sub-paragraph (b), for “£9,202” substitute “£9,653”;

(b) in paragraph (2)—

(i) in sub-paragraph (a), for “£781” substitute “£819”, and

(ii) in sub-paragraph (b), for “£2,184” substitute “£2,291”;

(c) in paragraph (3)—

(i) in sub-paragraph (a), for “£3,948” substitute “£4,141”, and

(ii) in sub-paragraph (b), for “£9,262” substitute “£9,653”;

(d) in paragraph (4)—

(i) in sub-paragraph (a), for “£781” substitute “£819”, and

(ii) in sub-paragraph (b), for “£2,184” substitute “£2,291”; and

(e) in paragraph (5)—

(i) in sub-paragraph (a), for “£40,374” substitute “£42,352”, and

(ii) in sub-paragraph (b), for “£10,024” substitute “£10,515”.