# The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006 S.I. 2006/494 · made 27 February 2006 · revised to 1 April 2008 These Regulations make further amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations”), the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the Devices Regulations”) and the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”). PDFs: Printed copy https://openlegislation.uk/medicines-for-human-use-and-medical-devices-fees-amendments-regulations-2006/pdf/uksi_20060494_en.pdf; Explanatory Memorandum https://openlegislation.uk/medicines-for-human-use-and-medical-devices-fees-amendments-regulations-2006/pdf/uksiem_20060494_en.pdf ## Introductory text FEES AND CHARGES MEDICINES Made 27th February 2006 Laid before Parliament 3rd March 2006 Coming into force 1st April 2006 The Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971 or, as the case may be, the powers conferred by those provisions and now vested in them . In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972 and section 56(1) and (2) of the Finance Act 1973 . The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products . The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973. In accordance with section 129(6) of the Medicines Act 1968 , the Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations. ## 1 Citation, commencement and interpretation (1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006 and shall come into force on 1st April 2006. (2) In these Regulations— “the Devices Regulations” means the Medical Devices (Consultation Requirements)(Fees) Regulations1995 ; “the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995 ; and “the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 . ## 2 Amendment of the General Fees Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Amendment of the Homoeopathic Products Regulations (1) The Homoeopathic Products Regulations are amended as follows. (2) In regulation 14 (fees for variations of certificates)— (a) in paragraph (2)(a), for “£218” substitute “ £226 ”; (b) in paragraph (2)(b)(i), for “£218” substitute “ £226 ”; (c) in paragraph (2)(b)(ii), for “£218” substitute “ £226 ”; (d) in paragraph (2)(b)(iii), for “£110” substitute “ £114 ”; and (e) in paragraph (2)(b)(iv), for “£55” substitute “ £57 ”. (3) In the table in Schedule 2 (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 “£134” substitute “ £148 ”; (ii) for “£402” substitute “ £444 ”; and (iii) for “£664” substitute “ £734 ”; and (b) in column (3) (fees for other applications)— (i) for “£330” substitute “ £365 ”; (ii) for “£592” substitute “ £654 ”; (iii) for “£869” substitute “ £960 ”. ## 4 Amendment of regulation 3 of the Devices Regulations (1) In regulation 3 of the Devices Regulations (fees)— (a) in paragraph (1)(a), for “£3,575” substitute “ £3,948 ”; (b) in paragraph (1)(b), for “£8,333” substitute “ £9,202 ”; (c) in paragraph (2)(a), for “£707” substitute “ £781 ”; (d) in paragraph (2)(b), for “£1,978” substitute “ £2,184 ”; (e) in paragraph (3)(a), for “£3,575” substitute “ £3,948 ”; (f) in paragraph (3)(b), for “£8,333” substitute “ £9,262 ”; (g) in paragraph (4)(a), for “£707” substitute “ £781 ”; (h) in paragraph 4(b), for “£1,978” substitute “ £2,184 ”; (i) in paragraph (5)(a), for “£36,560” substitute “ £40,374 ” and (j) in paragraph (5)(b), for “£9,077” substitute “ £10,024 ”. ## Signature Signed by authority of the Secretary of State for Health Jane Kennedy Minister of State, Department of Health Sealed with the Official Seal of the Department of Health, Social Services and Public Safety Andrew McCormick Permanent Secretary, Department of Health, Social Services and Public Safety Sealed with the Official Seal of the Department of Agriculture and Rural Development Pat Toal Permanent Secretary, Department of Agriculture and Rural Development We consent, Gillian Merron and Tom Watson Two of the Lords Commissioners of Her Majesty's Treasury ## . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Explanatory note (This note is not part of the Regulations) These Regulations make further amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations”), the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the Devices Regulations”) and the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”). The General Fees Regulations make provision for the fees payable under the Medicines Act 1971, and other fees payable in respect of Community obligations, relating to marketing authorizations, licences and certificates in respect of medicinal products for human use. Regulation 2 and the Schedule to these Regulations provide for a number of the fees payable by virtue of the General Fees Regulations to be increased. The increases are of amounts between 4% and 42.8%, Most capital fees have been increased by amounts between 10% and 19%, periodic fees have been increased by 17% and all but two of the inspection fees have been increased by 42.8% (the remaining two inspection fees have both been increased by 4%). Regulation 2 also provides for certain provisions of the General Fees Regulations to be revoked. Those provisions provided for particular fees to be payable in respect of manufacturer's licences where those licences related solely to import of medicines from third countries. The revocation of those provisions means that the fees payable in respect of such licences will be the same as for other manufacturers' licences (i.e for manufacturer's licences which do not relate solely to import of medicines from third countries). The Homoeopathic Products Regulations implemented in part Council Directive 92/73/EEC (now replaced by Directive 2001/83/EC ) by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. Regulation 3 of these Regulations amends the Homoeopathic Products Regulations so as to increase the amounts of the fees payable for applications for, and variations of, certificates of registration and the fees payable by holders of certificates of registration. The increases average overall 10%. The Devices 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. Regulation 4 of these Regulations amends the Devices Regulations by increasing the amounts of the fees specified in regulation 3 of those Regulations. The increases average overall 10%. A full Regulatory Impact Assessment of the effect that this instrument will have on the costs of business has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ --- Source: https://www.legislation.gov.uk/uksi/2006/494 (the official version) Page: https://openlegislation.uk/medicines-for-human-use-and-medical-devices-fees-amendments-regulations-2006 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.