The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002 and shall come into force on 1st April 2002.

(2) In these Regulations—

“the Devices Regulations” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995(1);

“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995(2);

“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(3); and

“the Marketing Authorisations Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(4).

Amendment of the Homoeopathic Products Regulations

2.—(1) In regulation 6 of the Homoeopathic Products Regulations (grant of a certificate), omit paragraph (b).

(2) In regulation 9 of the Homoeopathic Products Regulations(5) (suspension and revocation), omit paragraph (3).

(3) In regulation 14 of the Homoeopathic Products Regulations(6) (fees for variations of certificates)—

(a) in paragraph (1)(a), for “£95” substitute “£103”;

(b) in paragraph (1)(b)(i), for “£95” substitute “£103”;

(c) in paragraph (1)(b)(ii), for “£45” substitute “£51.50”;

(d) in paragraph (2)(a), for “£185” substitute “£200”;

(e) in paragraph (2)(b)(i), for “£185” substitute “£200”;

(f) in paragraph (2)(b)(ii), for “£185” substitute “£200”;

(g) in paragraph (2)(b)(iii), for “£88” substitute “£100”; and

(h) in paragraph (2)(b)(iv), for “£44” substitute “£50”.

(4) In regulation 15(1) of the Homoeopathic Products Regulations(7) (fees payable by holders of certificates), for “£12” substitute “£13”.

(5) In the Table in Schedule 2 to the Homoeopathic Products Regulations(8) (fees for applications for the grant of certificates of registration)—

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

(i) for “£113” substitute “£122”,

(ii) for “£341” substitute “£368”, and

(iii) for “£562” substitute “£607”; and

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

(i) for “£280” substitute “£302”,

(ii) for “£502” substitute “£542”, and

(iii) for “£736” substitute “£795”.

Amendment of the Marketing Authorisations Regulations

3.—(1) The Marketing Authorisations Regulations are amended as follows.

(2) In regulation 5 (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization), omit paragraph (2).

(3) After regulation 5 (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization) insert the following regulation—

“Classification of medicinal products

5A.— (1) Each marketing authorization granted by the licensing authority on or after 1st April 2002 shall be granted subject to a condition that the medicinal product to which the authorization relates is to be available—

(a) only on prescription;

(b) only from a pharmacy; or

(c) on general sale.

(2) Where prior to 1st April 2002 a medicinal product is subject to a marketing authorization and that authorization contains a statement that it is to be available on one or more of the following bases—

(a) only on prescription;

(b) only from a pharmacy; or

(c) on general sale,

it is a condition of the marketing authorization from 1st April 2002 that the product is to be available only on that basis or, as the case may be, those bases.”.

(4) In regulation 6 (revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products), omit paragraph (8).

(5) Regulation 8 (control of sale or supply of relevant medicinal products) is hereby revoked.

(6) In paragraph 6(2) of Schedule 5 (labels), for head (a) substitute—

“(a) if the product would be subject to restrictions imposed under section 58 of the Act if it contained a higher proportion or level of any substance, except where the product is for external use only or contains any of the substances described in head (c) of this sub-paragraph, the words “Warning. Do not exceed the stated dose”;”.

Amendment of regulation 3 of the Devices Regulations

4.  In regulation 3 of the Devices Regulations(9) (fees)—

(a) in paragraph (1)(a), for “£3,029” substitute “£3,271”;

(b) in paragraph (1)(b), for “£6,726” substitute “£7,264”;

(c) in paragraph (2)(a), for “£599” substitute “£647”;

(d) in paragraph (2)(b), for “£1,676” substitute “£1,810”;

(e) in paragraph (3)(a), for “£2,285” substitute “£3,271”;

(f) in paragraph (3)(b), for “£6,406” substitute “£7,264”;

(g) in paragraph (4)(a), for “£570” substitute “£647”;

(h) in paragraph (4)(b), for “£1,596” substitute “£1,810”;

(i) in paragraph (5)(a), for “£30,972” substitute “£33,450”; and

(j) in paragraph (5)(b), for “£7,690” substitute “£8,305”.

Amendment of the General Fees Regulations

5.—(1) The General Fees Regulations are amended as follows.

(2) In regulation 2(1) (interpretation) after the definition of “the 2001 Directive”(10) insert the following definition—

““Directive 75/319/EEC” means Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(11), as amended(12);”.

(3) After Part IV of the General Fees Regulations (capital fees for applications for renewals of clinical trial certificates and for certain manufacturer’s licences and for associated inspections) insert the following Part—

“PART IVA CAPITAL FEES FOR REGULATORY ASSISTANCE GIVEN BY THE UNITED KINGDOM ACTING AS REFERENCE MEMBER STATE RELATING TO THE ASSESSMENT OF APPLICATIONS FOR THE RENEWAL OF SPECIFIED MARKETING AUTHORIZATIONS

12A.— (1) Subject to regulation 19, where—

(a) an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization in relation to a medicinal product which has been subject to the procedures specified in paragraph (2); and

(b) the United Kingdom is to provide regulatory assistance acting as reference Member State in relation to that application,

there shall be payable by the applicant the fee prescribed in Part IV of Schedule 1 in connection with that regulatory assistance.

(2) The procedures referred to in paragraph (1) are—

(a) the procedures laid down in Articles 7 and 7a of Council Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(13), as amended(14), and in Articles 17 and 18 of the 2001 Directive(15);

(b) the procedures laid down in Article 9(4) of Directive 75/319/EEC and in Article 28(4) of the 2001 Directive;

(c) the procedures laid down in Articles 10 to 14 of Directive 75/319/EEC and in Articles 29 to 34 of the 2001 Directive;

(d) referral to the Committee for Proprietary Medicinal Products(16) in accordance with Council Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology(17), if the opinion of the Committee in accordance with Article 4.1 of that Directive was given before 1st January 1995.

(3) For the purposes of this regulation and Part IV of Schedule 1, the United Kingdom provides regulatory assistance acting as reference Member State in relation to an application for renewal of a United Kingdom marketing authorization where the licensing authority prepares or updates an assessment report in respect of the medicinal product in question for the purpose of making such report available to the competent authorities of another EEA state in which an application has been made for the renewal of a marketing authorization relating to that product in that state.

12B.   Subject to regulation 19, all sums payable by way of fees under regulation 12A(1) shall be payable at the time when the application for renewal of the United Kingdom marketing authorization is made to the licensing authority.”.

(4) In Part I of Schedule 1 (interpretation), in paragraph 1, in the definition of “complex application”, at the end of sub-paragraph (i) add “, except where a European Pharmacopoeia certificate of suitability covering the active ingredient has been submitted with the application”.

(5) In Part II of Schedule 1 (capital fees for applications for authorizations, licences and certificates)—

(a) in paragraph 1—

(i) in sub-paragraph (1), for “paragraphs 2, 3 and 4” substitute “paragraphs 1A, 2, 3 and 4”, and

(ii) in sub-paragraph (2), for “paragraphs 3 and 4” substitute “paragraphs 1A, 3 and 4”;

(b) after paragraph 1 insert the following paragraph—

“1A.— (1) Subject to paragraph 4, where an application, other than a major application, includes a reclassification element, an amount of £6,000 shall be payable in addition to the amount payable under paragraph 1 in respect of that application.

(2) For the purposes of this paragraph and paragraph 4, an application includes a reclassification element if—

(a) the medicinal product in question is to be available in the United Kingdom only from a pharmacy, unless there is an analogous medicinal product available in the United Kingdom only from a pharmacy or on general sale; or

(b) the medicinal product in question is to be available in the United Kingdom on general sale, unless there is an analogous medicinal product also so available.

(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorization or a Community marketing authorization and which—

(a) has the same active ingredient, route of administration and use;

(b) has the same strength or a higher strength;

(c) has the same dosage or daily dosage, or a higher dosage or daily dosage; and

(d) is for sale or supply at the same quantity or a greater quantity,

as the medicinal product in relation to which the application is made.”; and

(c) in paragraph 4—

(i) in sub-paragraph (1), for “sub-paragraphs (2) and (3)” substitute “sub-paragraphs (2) to (4)”; and

(ii) after sub-paragraph (3), insert the following sub-paragraph—

“(4) If the application includes any applications for marketing authorizations that include a reclassification element, the amount payable shall be the amount payable in accordance with sub-paragraphs (1) to (3) plus—

(a) in respect of the first marketing authorization applied for that includes a reclassification element, the additional amount payable under paragraph 1A(1); and

(b) in respect of each other marketing authorization applied for that includes a reclassification element, £458.”.

(6) In Part III of Schedule 1 (capital fees for applications for variations of marketing authorizations, licences and certificates)—

(a) in paragraph 1—

(i) before the definition of “Type I Application” insert the following definition—

• ““reclassification variation application” means an application for variation of a marketing authorization which has the effect that a medicinal product to which that authorization relates—

  (a)

  is to be available only from a pharmacy, where previously it was available only on prescription;

  (b)

  is to be available on general sale, where previously it was available only on prescription or only from a pharmacy;”; and

(ii) in the definition of “Type II Application”, for the words from “neither a Type I Application” to the end substitute “not a reclassification variation application, a Type I Application, a Type II Complex Variation Application or a change to which Annex II to Commission Regulation (EC) 541/95 applies”;

(b) in paragraph 2—

(i) for “13 and 14” substitute “13 to 15”; and

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

“(d) where the application is a reclassification variation application, £6,000.”;

(c) after paragraph 5, insert the following paragraph—

“5A.— (1) Where an application is a reclassification variation application to which this paragraph applies, the fee payable under regulation 7(1) in connection with the application for variation of a marketing authorization shall be £458.

(2) This paragraph applies to a reclassification variation application which would have the effect that a medicinal product to which the marketing authorization relates—

(a) is to be available only from a pharmacy (where previously it was available only on prescription), if an analogous medicinal product is available only from a pharmacy or on general sale; or

(b) is to be available on general sale (where previously it was available only on prescription or only from a pharmacy), if an analogous medicinal product is available on general sale.

(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorization or a Community marketing authorization and which—

(a) has the same active ingredient, route of administration and use;

(b) has the same strength or a higher strength;

(c) has the same dosage or daily dosage, or a higher dosage or daily dosage; and

(d) is for sale or supply at the same quantity or a greater quantity,

as the medicinal product in relation to which the variation application is made.”;

(d) in paragraph 6—

(i) after sub-paragraph (a)(vii)(18) insert the following sub-paragraph—

“(viii) if the marketing authorization was not a parallel import licence, the application for that variation would be a reclassification variation application to which paragraph 5A of this Schedule applies,”;

(ii) for sub-paragraph (b) substitute the following sub-paragraphs—

“(b) where the application would be a reclassification variation application to which paragraph 5A of this Schedule does not apply, if the marketing authorization was not a parallel import licence, shall be £6,000; and

(c) in any other case, shall be £270.”;

(e) in paragraph 12, for “paragraph 14” substitute “paragraphs 14 and 15”; and

(f) after paragraph 14, insert the following paragraph—

“Multiple reclassification variation applications

15.   Where more than one reclassification variation application is made at the same time by the same applicant, each relating to medicinal products which have the same active ingredient or combination of ingredients, the fee payable under regulation 7(1)—

(a) if one or more of the applications is an application to which paragraph 5A does not apply—

(i) in connection with the first application to which paragraph 5A does not apply, shall be the appropriate amount specified in this Part of the Schedule;

(ii) in connection with each other application to which paragraph 5A does not apply, shall be £458; and

(iii) in connection with each other application to which paragraph 5A does apply, shall be £229;

(b) in any other case—

(i) in connection with the first application, shall be the appropriate amount specified in this Part of the Schedule; and

(ii) in connection with each other application, shall be £229.”.

(7) After Part III of Schedule 1 (capital fees for applications for variations of authorizations, licences and certificates) insert the following Part—

“PART IV CAPITAL FEES FOR REGULATORY ASSISTANCE GIVEN BY THE UNITED KINGDOM ACTING AS REFERENCE MEMBER STATE RELATING TO THE ASSESSMENT OF APPLICATIONS FOR THE RENEWAL OF SPECIFIED MARKETING AUTHORIZATIONS

1.   Subject to paragraph 2, the fee payable under regulation 12A(1) in connection with regulatory assistance provided by the United Kingdom acting as reference Member State where an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization in relation to a medicinal product which has been subject to the procedures specified in regulation 12A(2), shall be—

(a) if the application for renewal relates to a medicinal product which, at the time the United Kingdom marketing authorization was granted, contained a new active ingredient and that renewal is the first renewal in relation to which the United Kingdom is to provide regulatory assistance acting as reference Member State, a fee of £6,784,

(b) in every other case, a fee of £554.

2.   Where more than one application falling within regulation 12A(1) is made by the same applicant at the same time, each relating to medicinal products which have the same active ingredient or combination of ingredients, dosage form, therapeutic indications and Periodic Safety Update Reports, and the United Kingdom marketing authorizations for those products have the same date for renewal, the fee payable under regulation 12A(1) shall be—

(a) if the applications fall within paragraph 1(a)—

(i) in connection with the first application considered by the licensing authority, the amount specified in paragraph 1(a), and

(ii) in connection with each other application, a fee of £554;

(b) if the applications fall within paragraph 1(b)—

(i) in connection with the first application considered by the licensing authority, the amount specified in paragraph 1(b), and

(ii) in connection with each other application, a fee of £277.”.

(8) In Schedule 5 (waiver, reduction or refund of capital fees), after paragraph 2A(19), insert the following paragraph—

“2B.— (1) Where—

(a) an application for a marketing authorization includes a reclassification element in accordance with paragraph 1A of Part II of Schedule 1; and

(b) the licensing authority is satisfied that the reclassification element does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Medicines Commission,

50% of the additional amount payable under paragraphs 1A(1) or 4(4)(a) of Part II of that Schedule shall be refunded, or if it has not yet been paid, shall be waived.

(2) Where—

(a) an application for variation of a marketing authorization is a reclassification variation application (not being an application falling within paragraph 5A of Part III of Schedule 1); and

(b) the licensing authority is satisfied that the application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Medicines Commission,

50% of the fee payable under paragraphs 2(2)(d) or 15(a)(i) of Part III of Schedule 1 shall be refunded, or if it has not yet been paid, shall be waived.

(3) Where—

(a) an application for variation of a parallel import licence falls within paragraph 6(b) of Part III of Schedule 1; and

(b) the licensing authority is satisfied that the application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Medicines Commission,

50% of the fee payable under that paragraph shall be refunded, or if it has not yet been paid, shall be waived.

(4) For the purposes of paragraphs (1) to (3), a reclassification element or, as the case may be, a variation application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Medicines Commission where—

(a) the licensing authority was satisfied that the application did not require consideration by such a committee or that Commission; and

(b) the committee or the Commission are consulted only by virtue of, or in accordance with, paragraph 5 of Schedule 2 to the 1994 Regulations (procedural provisions relating to the grant, renewal, variation, revocation and suspension of United Kingdom marketing authorizations).”.

(9) In each provision of the General 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.

Signed by authority of the Secretary of State for Health

Hunt

Parliamentary Under Secretary of State,

Department of Health

6th March 2002

Whitty

Parliamentary Under Secretary of State,

Department for Environment, Food and Rural Affairs

11th March 2002

Bairbre de Brún

Minister of Health, Social Services and Public Safety

11th March 2002

Bríd Rodgers

Minister of Agriculture and Rural Development

11th March 2002

We consent,

Anne McGuire

Nick Ainger

Two of the Lords Commissioners of Her Majesty’s Treasury

6th March 2002