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Statutory Instrument 1998 No. 574The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998(The document as of February, 2008) STATUTORY INSTRUMENTS1998 No. 574The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998
The Secretary of State concerned with health in England, the Secretaries of State concerned with health and agriculture in Wales and Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly and with the consent of the Treasury, in exercise of powers conferred upon them by section 1(1) and (2) of the Medicines Act 1971[1], or, as the case may be, powers conferred by those provisions and now vested in them[2], the Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972[3] in relation to medicinal products[4], in exercise of the powers conferred upon him by the said section 2(2), and the Secretary of State, with the consent of the Treasury, in exercise of the powers conferred upon him by section 56(1) and (2) of the Finance Act 1973[5], and in each case in exercise of all other powers respectively enabling them in that behalf, after consultation (in so far as is required by section 129(6) of the Medicines Act 1968[6], as extended by section 1(3)(b) of the Medicines Act 1971) with such organisations as appear to them to be representative of interests likely to be substantially affected, hereby make the following Regulations: - 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 1998 and shall come into force on 1st April 1998. (2) In these Regulations -
Amendment of the Homoeopathic Products Regulations
(b) the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent; (c) a change to the qualitative composition of the container or other form of packaging immediately in contact with the product; (d) a minor change to the method of manufacture of a homoeopathic stock included in the product; (e) a change to the specification of any reagent or excipient used in the manufacture of the product; (f) a change to the finished product specification of the product; (g) a change to the test procedure for any raw material used in the manufacture of the product; (h) a change to the test procedure for the product; (i) a change to the test procedure for the container or other form of packaging immediately in contact with the product; (j) a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a member State; (k) a change to the shape of the container in which the product may be placed on the market; (l) an additional pack size in which the product may be placed on the market; (m) a change to the approved storage conditions for the product; (n) a change to the shelf life of an unopened container of the product or to the shelf life of the product after the container has been opened for the first time; or (o) a change to the dimensions of an approved dosage form of the product (for example, tablets) which does not entail a change to the quantitative composition or the mean mass of the product;". (2) In regulation 11 of the Homoeopathic Products Regulations (variation of certificates) -
(b) the words from "which relate to" to the end of the regulation shall be omitted. (3) For regulation 14 of the Homoeopathic Products Regulations (fees for variations of certificates) there shall be substituted the following regulation -
14. - (1) The fee payable by an applicant in connection with an application for an administrative variation of a certificate of registration pursuant to regulation 11 of these Regulations shall be -
(b) where more than one application for an administrative variation is made at the same time by the same applicant and the applications are for identical variations -
(ii) in respect of each other application so considered, a fee of £37.50. (2) The fee payable by an applicant in connection with an application for a standard variation of a certificate of registration pursuant to regulation 11 of these Regulations shall be -
(b) where more than one application for a standard variation is made at the same time by the same applicant and the applications are for identical variations -
(ii) in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of £150, (iii) in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of £75.". (4) In regulation 15(1) of the Homoeopathic Products Regulations (fees payable by holders of certificates), for "£15" there shall be substituted "£10".
(ii) for "£300" there shall be substituted "£270", and (iii) for "£500" there shall be substituted "£450"; and (b) in column (3) (fees for other applications) -
(ii) for "£450" there shall be substituted "£400", and (iii) for "£650" there shall be substituted "£585". Amendment of regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995
(b) in paragraph (1)(b), for "£5,950" there shall be substituted "£5,355"; (c) in paragraph (2)(a), for "£530" there shall be substituted "£475"; (d) in paragraph (2)(b), for "£1,485" there shall be substituted "£1,335"; (e) in paragraph (3)(a), for "£2,125" there shall be substituted "£1,910"; (f) in paragraph (3)(b), for "£5,950" there shall be substituted "£5,355"; (g) in paragraph (4)(a), for "£530" there shall be substituted "£475"; (h) in paragraph (4)(b), for "£1,485" there shall be substituted "£1,335"; (i) in paragraph (5)(a), for "£27,200" there shall be substituted "£24,500"; and (j) in paragraph (5)(b), for "£6,800" there shall be substituted "£6,120". Amendment of the General Fees Regulations
(b) paragraph 5(2)(c) of Schedule 2; (c) the definitions of "reduced rate fee" and "standard fee" in paragraph 1 of Part I of Schedule 3; and (d) paragraph 8(2)(a) of Part III of Schedule 3, for "£30,000" there shall be substituted "£35,000".
(b) for the words ""Type II complex variation" means" there shall be substituted the words ""Type II Complex Variation Application" means an application for"; and (c) for sub-paragraph (b) of what, by virtue of the preceding sub-paragraph, is the definition of "Type II Complex Variation Application" there shall be substituted the following sub-paragraph -
(ii) accompanied by evidence relating to post-marketing experience which is information of any type described in Section H of Part IV of the Annex to Council Directive 75/318/EEC[11] (clinical documentation); or". (3) In paragraphs 2(c) and 3(c) of Part III of Schedule 1 to the General Fees Regulations, for the words "complex variation", at each place where they occur, there shall be substituted the words "Complex Variation Application".
(This note is not part of the Regulations) These Regulations further amend the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 ("the Homoeopathic Products Regulations"), the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 ("the Consultation Requirements Regulations") and the Medicines (Products for Human Use - Fees) Regulations 1995 ("the General Fees Regulations"). The Homoeopathic Products Regulations implemented in part Council Directive 92/73/EEC[13] by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. These Regulations introduce a new category of permissible variation of certificates of registration, allowing for certificates to be varied in some circumstances where medical, scientific or pharmaceutical assessment is required (regulation 2(1) and (2)). The fee payable in respect of variations is £75 (for administrative) or £150 (for standard), reduced by half in respect of certain applications for identical variations (regulation 2(3)). The periodic fee payable by holders of certificates of registration is reduced from £15 to £10 (regulation 2(4)), and the capital fees for applications for the grant of certificates of registration are reduced by an average overall of 10% (regulation 2(5)). The Consultation Requirements Regulations prescribe the fees which are payable where a notified body consults the competent body in accordance with Council Directive 93/42/EEC concerning medical devices[14]. Regulation 3 of these Regulations amends regulation 3 of the Consultation Requirements Regulations by reducing the amounts of all the fees specified in those Regulations by an average overall of 10%. As a consequence, the Medical Devices (Consultation Requirements) (Fees) Amendment Regulations 1996 are revoked (regulation 6). The General Fees Regulations make provision for the fees payable under the Medicines Act 1971 relating to marketing authorizations, licences and certificates in respect of medicinal products for human use. These Regulations change the turnover threshold for reductions on certain of the fees for small businesses from £30,000 to £35,000 (regulation 4(1)). They also change the definition relating to major complex variation applications which applies for the purposes of Part III of Schedule 1 to the General Fees Regulations so that the higher major complex variation application fee is now generally payable in respect of applications which must include evidence relating to certain studies, tests or trials and which require substantial assessment resources on the part of the licensing authority (regulation 4(2) to (4)). Dates relating to the calculation of turnover for periodic fees' purposes are made consistent with the dates relating to other calculations under Schedule 3 (regulation 4(5)), and a periodic fee will no longer be charged for homoeopathic product licences of right or for anthroposophic products (regulation 4(6)). There is also a package of changes relating to the levels of certain capital fees payable for applications for marketing authorizations, manufacturers' licences, wholesale dealers' licences, clinical trial certificates and export certificates; fees for variations and renewals of such authorizations, licences and certificates; periodic fees payable in connection with the holding of certain authorizations and licences; and fees payable in connection with certain site inspections (regulation 5 and the Schedule). No fees have been increased. Most of the capital fees have been reduced, by amounts varying between 0.5% and 65%; periodic fees have been reduced by an average overall of 14%; and just under half of the fees for site inspections have been reduced, by amounts varying between 0.5% and 26%. A Regulatory Appraisal in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines Control Agency, Room 2102, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Notes: [1] 1971 c.69; as amended by section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the 1971 Act expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67) as amended by the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); see therefore section 1(1) of the 1968 Act, as so amended, which contains a definition of "the Ministers" which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144) by virtue of which the references in section 1(1) and (2)(b) of the 1971 Act to a licence under Part II of the 1968 Act include reference to a marketing authorization under those Regulations.back [2] In the case of the Secretaries of State concerned with health in England and in Wales, by virtue of article 2(2) of and Schedule 1 to the Transfer of Functions (Wales) Order 1969; in the case of the Secretary of State concerned with agriculture in Wales, by virtue of article 2(3) of and Schedule 1 to the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern Ireland Departments, by virtue of section 40 of and Schedule 5 to the Northern Ireland Constitution Act 1973 (c.36) and section 1(3) of and paragraph 2(1)(b) of Schedule 1 to the Northern Ireland Act 1974 (c.28).back [3] 1972 c.68.back [4] S.I. 1972/1811.back [5] 1973 c.51.back [6] 1968 c.67.back [7] S.I. 1995/1116; amended by S.I. 1996/683.back [8] S.I. 1994/105; amended by S.I. 1995/541 and 1996/482.back [9] S.I. 1995/449; amended by S.I. 1996/622.back [10] OJ No. L 55, 11.3.95, p. 7.back [11] OJ No. L 147, 9.6.75, p. 1; amended by Council Directive 83/570/EEC (OJ No. L 332, 28.11.83, p. 1), Council Directive 87/19/EEC (OJ No. L 15, 17.1.87, p. 31), Council Directive 89/341/EEC (OJ No. L 142, 25.5.89, p. 11), Commission Directive 91/507/EEC (OJ No. L 270, 26.9.91, p. 32) and Council Directive 93/39/EEC (OJ No. L 214, 24.8.93, p. 22).back [12] S.I. 1996/622.back [13] OJ No. L 297, 13.10.92, p. 8.back [14] OJ No. L 169, 12.7.93, p. 1.back ISBN 0 11 065663 6 -- Back --
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