# The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003 S.I. 2003/2321 · made 8 September 2003 · revised to 1 April 2009 These regulations make amendments to the Medicines Act 1968, the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1995 (“the Marketing Authorisations Regulations”), the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”) and various other statutory instruments relating to medicinal products. PDFs: Printed copy https://openlegislation.uk/medicines-for-human-use-fees-and-miscellaneous-amendments-regulations-2003/pdf/uksi_20032321_en.pdf ## Introductory text FEES AND CHARGES MEDICINES Made 8th September 2003 Laid before Parliament 9th September 2003 Coming into force For the purposes of regulations 7(2)(a)(ii) & (b), (3) & (4)(a), 8(2)(b) & (3), 9, 11(2)(a), (b) & (c)(i), (ii), (iii)(aa) & (iv), (3), (4) & (6) and 13 1st October 2003 For all other purposes 31st October 2003 The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products , in exercise of the powers conferred upon him by the said section 2(2), 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 , the Secretary of State, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, 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 , or, as the case may be, powers conferred by those provisions and now vested in them , and in each case in exercise of all other powers respectively enabling them in that behalf, after consultation in accordance with section 129(6) of the Medicines Act 1968 with such organisations as appear to them to be representative of interests likely to be substantially affected, hereby make the following Regulations: ## 1 Citation, commencement and interpretation (1) These Regulations may be cited as the Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003. (2) These Regulations shall come into force— (a) for the purposes of— (i) regulation 7(2)(a)(ii) and (b), (3) and (4)(a), (ii) regulation 8(2)(b) & (3), (iii) regulation 9, (iv) regulation 11, except paragraphs (2)(c)(iii)(bb) and (5), and (v) regulation 13, on 1st October 2003, and (b) for all other purposes, on 31st October 2003. (3) In these Regulations, “the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995 . ## 2 Amendment of the Medicines Act 1968 In the Medicines Act 1968 , in section 132 (interpretation), in paragraph (1), in the definition of “the 2001 Directive”, after “human use”insert “ , as amended ”. ## 3 Amendment of the Standard Provisions Regulations 1971 In the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 — (a) in regulation 2 (interpretation), in paragraph (1), in the definition of “the 2001 Directive”, after “human useinsert “ , as amended ”; and (b) in Part I of Schedule 1 (standard provisions for product licences), in paragraph 16, for “Part 4G of Annex I to the 2001 Directive” substitute “ point 6 of Part II of Annex I to the 2001 Directive ”. ## 4 Amendment of the Product Licences Regulations 1993 In the Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993 — (a) in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”; and (b) in Schedule 1 (information, documents etc. required in respect of applications)— (i) in paragraph 17, for “Part 3, paragraph 1.1, second sub-paragraph of the Annex I to the 2001 Directive” substitute “ paragraph (9) of the Introduction and general principles of Annex I to the 2001 Directive ”, and (ii) in paragraph 18, for “Part 4, paragraph B.2 of the Annex I to the 2001 Directive” substitute “ paragraph 5.2(a) of Part I of Annex I to the 2001 Directive ”. ## 5 Amendment of the Homoeopathic Medicinal Products for Human Use Regulations 1994 In the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 , in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”. ## 6 Amendment of the Advertising Regulations 1994 In the Medicines (Advertising) Regulations 1994 , in regulation 1 (interpretation), in paragraph (1), in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”. ## 7 Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (1) The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 shall be amended as follows. (2) In regulation 1 (citation, commencement and interpretation)— (a) in paragraph (2)— (i) in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”, and (ii) in the definition of “the relevant Community provisions”— (aa) omit “Regulation (EC) No. 541/95, as amended” and “Regulation (EC) No. 542/95, as amended”, and (bb) after “Regulation (EC) No. 847/2000” insert the following entries— “Regulation (EC) No. 1084/2003 , and Regulation (EC) No. 1085/2003 ;”; and (b) in paragraph (4), after sub-paragraph (b) insert the following sub-paragraph— “(bb) any reference in these Regulations to an application for the variation of a marketing authorization includes a reference to a notification of such a variation, and any reference to an applicant for a variation to a marketing authorization includes a reference to a person submitting such a notification; and”. (3) After regulation 6 (revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products), insert the following regulation— “Urgent safety restrictions 6A (1) The licensing authority may, subject to and in accordance with the relevant Community provisions, impose an urgent safety restriction on the holder of a United Kingdom marketing authorization. (2) Where the licensing authority imposes an urgent safety restriction in accordance with paragraph (1), the holder of the marketing authorization shall— (a) implement the restriction within a period specified by the licensing authority; and (b) apply to vary the authorization so as to take account of that safety restriction immediately and in any event not later than 15 days after the restriction was imposed.”. (4) In Schedule 3 (offences, penalties etc) — (a) after paragraph 3 insert the following paragraph— “ 3A Any person who is the holder of a marketing authorization who fails to implement an urgent safety restriction imposed on him by the licensing authority under regulation 6A or by the European Commission under Commission Regulation (EC) No. 1085/2003 shall be guilty of an offence.”; and (b) in paragraph 6, in sub-paragraph (c), for “paragraph D of Part 2 of Annex I to the 2001 Directive” substitute “ paragraphs 3.2(9), 3.2.1.2(c) and 3.2.2.4(c) of Part I of Annex I to the 2001 Directive ”. ## 8 Amendment of regulation 2 of the General Fees Regulations (1) Regulation 2 of the General Fees Regulations (interpretation) is amended as follows. (2) In paragraph (1)— (a) in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”; and (b) in the definition of “variation” for “Article 2.1 of Commission Regulation (EC) No. 541/95” substitute “ Article 3.1 of Commission Regulation (EC) No. 1084/2003 ”. (3) After paragraph (2) insert the following paragraph— “(3) In these Regulations any reference to an application for the variation of a marketing authorization includes a reference to a notification of such a variation, and any reference to an applicant for a variation to a marketing authorization includes a reference to a person submitting such a notification.”. ## 9 Amendment of regulation 3B of the General Fees Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Amendment of Part II of Schedule 1 to the General Fees Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Amendment of Part III of Schedule 1 to the General Fees Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Amendment of Schedule 3 to the General Fees Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Amendment of Schedule 5 to the General Fees Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Signature Signed by authority of the Secretary of State for Health Warner Parliamentary Under Secretary of State, Department of Health Sealed with the Official Seal of the Department of Health, Social Services and Public Safety D.C. Gowdy 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, Nick Ainger Joan Ryan Two of the Lords Commissioners of Her Majesty’s Treasury ## Explanatory note (This note is not part of the Regulations) These regulations make amendments to the Medicines Act 1968, the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1995 (“the Marketing Authorisations Regulations”), the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”) and various other statutory instruments relating to medicinal products. The Marketing Authorisations Regulations implemented in part the following provisions of European Community law: Council Directives 65/65/EEC , 75/318/EEC , 75/319/EEC and the Regulations adopted by the Commission under Article 15 of that Directive, 89/342/EEC , 89/343/EEC , 89/381/EEC , 92/26/EEC , 92/27/EEC and 92/73/EEC , now repealed and re-enacted by Directive 2001/83/EC (“the 2001 Directive”), and Council Regulation (EEC) No. 2309/93 and the Regulations adopted by the Commission under Article 15.4 or 22.1 of that Regulation. They provide for the manner of making applications for the grant, renewal or variation of a United Kingdom marketing authorization and for procedures for consideration, revocation, suspension and related matters. Regulation 7 of these Regulations amends the Marketing Authorisations Regulations as a consequence of— (a)Commission Regulations (EC) No. 1084/2003 and No. 1085/2003 , which make provision in relation to variations of marketing authorizations, including the adoption of urgent safety restrictions by competent authorities, and (b)the adoption of Commission Directive 2003/63/EC , which amends the 2001 Directive by substituting a new Annex I setting out standards and protocols in respect of the testing of medicinal products for which applications for marketing authorization are made. Regulations 2 to 6 amend the Medicines Act and various statutory instruments, so as to amend references to the 2001 Directive as a consequence of the adoption of Commission Directive 2003/63/EC. 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 and for certain other fees arising out of or relating to Community obligations in relation to such products. Regulations 8, 10 to 12 make changes to the provisions for fees for applications for marketing authorizations, and for variations of such authorizations, as a consequence of the adoption of Commission Regulation (EC) No. 1084/2003 and Commission Directive 2003/63/EC. In particular, regulation 11 makes provision for new fees for minor variations of Type IA and Type IB and for variations to add new indications for use of a product in a different therapeutic area or in respect of a different organ or other part of the human body (“Extended Type II Complex Variation Applications”). Regulation 9 amends regulation 3A of the General Fees Regulations so as to make provision for fees in respect of meetings at which the licensing authority provide scientific advice to potential applicants for variations to marketing authorizations. Regulation 13 amends Schedule 5 of the General Fees Regulations, which relates to refunds and waivers. Regulation 13(2) makes provision for the waiver of fees payable in connection with meetings at which the licensing authority provide scientific advice to potential applicants for marketing authorizations or variations of such authorizations. Regulation 13(3) provides for the waiver of fees for applications for variations of marketing authorizations which result from urgent safety restrictions imposed by the licensing authority. A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines and Healthcare products Regulatory Agency, Room 16-107, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. --- Source: https://www.legislation.gov.uk/uksi/2003/2321 (the official version) Page: https://openlegislation.uk/medicines-for-human-use-fees-and-miscellaneous-amendments-regulations-2003 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.