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Statutory Instrument 2004 No. 666The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004(The document as of February, 2008) STATUTORY INSTRUMENTS2004 No. 666FEES AND CHARGESMEDICINESThe Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004
The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972[1] in relation to medicinal products[2], 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[3], 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[4], or, as the case may be, powers conferred by those provisions and now vested in them[5], 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[6] 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 Amendments) Regulations 2004 and shall come into force on 1st April 2004. (2) In these Regulations -
Amendment of the Homoeopathic Products Regulations
(b) in paragraph (2)(b)(i), for "£216" substitute "£218"; (c) in paragraph (2)(b)(ii), for "£216" substitute "£218"; (d) in paragraph (2)(b)(iii), for "£108" substitute "£110"; and (e) in paragraph (2)(b)(iv), for "£54" substitute "£55". (3) In regulation 15(1)[11] (fees payable by holders of certificates), for "£14" substitute "£15".
(ii) for "£397" substitute "£402", and (iii) for "£656" substitute "£664"; and (b) in column (3) (fees for other applications) -
(ii) for "£585" substitute "£592", and (iii) for "£859" substitute "£869". Amendment of regulation 3 of the Devices Regulations
(b) in paragraph (1)(b), for "£8,234" substitute "£8,333"; (c) in paragraph (2)(a), for "£699" substitute "£707"; (d) in paragraph (2)(b), for "£1,955" substitute "£1,978"; (e) in paragraph (3)(a), for "£3,533" substitute "£3,575"; (f) in paragraph (3)(b), for "£8,234" substitute "£8,333"; (g) in paragraph (4)(a), for "£699" substitute "£707"; (h) in paragraph (4)(b), for "£1,955" substitute "£1,978"; (i) in paragraph (5)(a), for "£36,126" substitute "£36,560"; and (j) in paragraph (5)(b), for "£8,969" substitute "£9,077". Amendment of regulation 2 of the General Fees Regulations
Amendment of Part IA of the General Fees Regulations
(ii) a post-authorization safety study protocol, (b) the advice is given to the holder of a United Kingdom marketing authorization or a Community marketing authorization and relates to -
(ii) a post-authorization safety study protocol;
(b) the advice is in connection with -
(ii) the procedure referred to in Article 35(2) of the 2001 Directive, in relation to a product range, or
(ii) an application to amend the time periods for submitting Periodic Safety Update Reports under Article 104(6) of the 2001 Directive, in relation to a product range.". (3) After regulation 3B, insert the following regulations -
3BB. - (1) Subject to regulation 19, where the licensing authority holds a meeting with a person for the purpose of providing pharmacovigilance advice to that person, there shall be payable by that person -
(b) in any other case, a fee of £1,346. (2) The time taken by the licensing authority for the purposes of paragraph (1) shall be the aggregate of times spent by each individual engaged in preparing for or attending the meeting on behalf of the authority. Amendment of regulation 4 of the General Fees Regulations
Amendment of regulation 5 of the General Fees Regulations
(b) after paragraph (2) insert the following paragraph -
Amendment of regulation 8 of the General Fees Regulations
18A. - (1) Subject to paragraph (2), if a person has failed to pay a periodic fee, at the time it should have been paid by virtue of regulation 18, a penalty fee shall be payable by that person. (2) A penalty fee is payable only if after 60 days following written notice from the licensing authority requiring payment of that fee, the fee remains unpaid. (3) Subject to regulation 18B, the penalty fee shall be -
(b) £50 where the total periodic fee unpaid by a person after such period does not exceed £200. (4) In paragraph (3), the "total periodic fee" means the aggregate of all the periodic fees payable by a person in connection with all the authorizations or licences held by that person.
(b) ends with the day before that on which payment of the outstanding amount is actually made. 18C.The licensing authority may refund or waive payment of the penalty fee, or reduce the amount payable, where it is satisfied that the holder of the authorization or licence was not responsible for the failure to pay the periodic fee within the period specified in regulation 18A(2) or 18B." Amendment of Part I of Schedule 1 to the General Fees Regulations
(b) in the definition of "simple application", in sub-paragraph (a), after "other than" insert "an application to which the first sub-paragraph of paragraph 3 of Part II of Annex I to the 2001 Directive applies or". Amendment of Schedule 2 to the General Fees Regulations
(a) the principles of good laboratory practice set out in Schedule 1 to the Good Laboratory Practice Regulations 1999[18], read with (b) the revised guidance for the conduct of test facility inspections and study audits set out in Schedule 2 to those Regulations;"; and (b) in the definition of "principle or guideline of good manufacturing practice"[19], for "Chapter II of Commission Directive 91/356/EEC[20] laying down the principles and guidelines of good manufacturing practice for medicinal products for human use" substitute "Commission Directive 2003/94/EC[21] laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use". (3) After paragraph 4, insert the following paragraph -
(b) if the laboratory carries out two types of analytical work, £3,000, and (c) if the laboratory carries out three or more types of analytical work, £4,000. (2) Where an inspection referred to in sub-paragraph (1) takes place at the same time as an inspection, by a person appointed by the Good Laboratory Practice Monitoring Authority under regulation 3(4) of the Good Laboratory Practice Regulations 1999, for the purposes of ascertaining whether a contract laboratory complies with the principles of good laboratory practice, the fee payable shall be -
(b) if the laboratory carries out two types of analytical work, £1,250, and (c) if the laboratory carries out three or more types of analytical work, £2,000. (3) The types of analytical work referred to in sub-paragraphs (1) and (2) are -
(b) microbiological analysis including sterility testing, (c) LAL endotoxin analysis, and (d) rabbit pyrogen testing.". Amendment of Schedule 5 to the General Fees Regulations
Amendment of the General Fees Regulations
(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 Homoeopathic Products Regulations implemented in part Council Directive 92/73/EEC[31] (now repealed and re-enacted in Directive 2001/83/EC[32]) by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. Regulation 2 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. These increases average overall 3.7 per cent. 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[33] concerning medical devices. Regulation 3 of these Regulations amends the Devices Regulations by increasing the amounts of the fees specified in regulation 3 of those Regulations by an average overall of 3.7 per cent. 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. Regulations 4 to 14 of these Regulations amend those Regulations as follows. Regulations 4(a) and (b), 6 to 10 and 13 make provision for fees for inspections of contract laboratories. Regulations 6 to 10 amend the provisions for fees for inspections so as to provide that when an inspection is made of a contract laboratory the fee for that inspection is payable by the operator of the laboratory. Regulation 13 introduces the new fee for inspections of contract laboratories. Regulations 4(c) and 11 make provision for new penalty fees for late payment of periodic fees. Regulation 5 amends regulation 3A of the General Fees Regulations and inserts new regulations to make provision for new fees for meetings at which the licensing authority provide pharmacovigilance, advertising, or regulatory advice, or advice on proposed changes to labelling or package leaflets, to holders of marketing authorizations or to potential applicants for a marketing authorization. Regulation 14 makes provision for the waiver of fees payable in connection with these meetings where the meeting has been held at the request of the licensing authority. Regulation 12 amends the definition of a complex application in Part I of Schedule 1 to the General Fees Regulations to add a new category of complex application as a consequence of the adoption of Commission Directive 2003/63/EC[34], which amends Directive 2001/83/EC[35] 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. There is also a package of changes to the General Fees Regulations relating to the levels of capital fees payable for applications for marketing authorizations, manufacturers' licences, wholesale dealers' licences, clinical trial certificates and export certificates; capital fees payable for variations and renewals of such authorizations, licences and certificates; capital fees payable for pre-application meetings; periodic fees payable in connection with the holding of certain authorizations and licences; and the fees payable in connection with site inspections (regulation 15 and the Schedule to these Regulations). There have been adjustments to specific capital fees, some increases and three reductions, plus a general 1.2 per cent increase, which together represent an overall 3.7 per cent increase in capital fees. Periodic fees have been increased by 3.7 per cent. 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. Notes: [1]1972 c. 68.back [2]S.I. 1972/1811.back [3]1973 c. 51.back [4]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); see therefore section 1(1) of the 1968 Act, as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, by article 5 of, and the Schedule to, S.I. 1999/3142, and by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794, 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 the 1994 Regulations.back [5]In the case of the Secretary of State, by virtue of articles 2(1) of, and paragraph 1 of the Schedule to, S.I. 1999/3142 and articles 3(1)(c) and (7) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794; and in the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, by virtue of the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) which may now be exercised by the Departments by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c. 1); the Departments were renamed by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I. 1).back [6]1968 c. 67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.back [7]S.I. 1995/449; as amended by S.I. 1998/574, 1999/566, 2000/592, 2001/795, 2002/236 and 542, and 2003/625.back [8]S.I. 1995/1116; as amended by S.I. 1996/683, 1998/574, 1999/566, 2000/592 and 3031, 2001/795, 2002/236 and 542, and 2003/625 and 2321.back [9]S.I. 1994/105; as amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2000/592, 2001/795, 2002/236 and 542, and 2003/625 and 2321.back [10]As amended by regulation 2(2) of S.I. 2003/625.back [11]As amended by regulation 2(3) of S.I. 2003/625.back [12]As amended by regulation 2(4) of S.I. 2003/625.back [13]As amended by regulation 3 of S.I. 2003/625.back [14]The definition of "concerned member State" was inserted by regulation 2 of S.I. 2000/3031.back [15]S.I. 1971/972; relevant amending instruments are S.I. 1977/1053 and 1992/2846.back [16]The definition of "parallel import licence" was inserted by regulation 5(1)(c) of S.I. 2001/795.back [17]Part 1A was inserted by regulation 4(3) of S.I. 2003/625 and amended by regulation 9 of S.I. 2003/2321.back [18]S.I. 1999/3106.back [19]The definition of "principle or guideline of good manufacturing practice" was inserted by regulation 4(1) and (7)(a)(ii) of S.I. 2003/625.back [20]OJ No. L 193, 17.7.1991, p. 30.back [21]OJ No. L 262, 14.10.1993, p. 22.back [22]Paragraph 1A was inserted by regulation 13(1) and (2) of S.I. 2003/2321.back [23]Regulation 3B was inserted by regulation 4(1) and (3) of S.I. 2003/625 and amended by regulation 9 of S.I. 2003/2321.back [24]Paragraphs 1A and 4(4) of Part II of Schedule 1 were inserted by regulation 5(5) of S.I. 2002/542.back [25]Part IIA was inserted by regulation 6 of S.I. 2000/2031.back [26]Paragraphs 2(d), 5A and 15 of Part III of Schedule 1 were inserted, and paragraph 6(b) and (c) of that Part was substituted, by regulation 5(6) of S.I. 2002/542back [27]Part IIIA of Schedule 1 was inserted by regulation 4(1) and (6) of S.I. 2003/625.back [28]Part IV of Schedule 1 was inserted by regulation 5(7) of S.I. 2002/542.back [29]Paragraph 5(3) was inserted by regulation 4(1) and (7)(e)(ii) of S.I. 2003/625.back [30]Paragraph 5A was inserted by regulation 4(1) and (7)(f) of S.I. 2003/625.back [31]OJ No. L 297, 13.10.1992, p. 8.back [32]See articles 1(5), 13 to 16, 53, 68, 69, 85, 100, 119 and 124.back [33]OJ No. L 169, 12.7.1993, p. 1; amended by Directive 98/79/EC (OJ No. L 331, 7.12.1998, p. 1).back [34]OJ No. L 159, 27.6.2003, p. 46.back [35]OJ No. L 311, 28.11.2001, p. 67.back ISBN0 11 048891 1 -- Back --
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