LegalizeThe Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004
Made: 10th March 2004
Laid before Parliament: 10th March 2004
Coming into force: 1st April 2004
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:
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—
- “the Devices Regulations” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 ;
- “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 .
Amendment of the Homoeopathic Products Regulations
2
- (1) The Homoeopathic Products Regulations are amended as follows.
- (2) In regulation 14 (fees for variations of certificates)—
- (a) in paragraph (2)(a), for “£216” substitute “ £218 ”;
- (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) (fees payable by holders of certificates), for “£14” substitute “ £15 ”.
- (4) 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 “£132” substitute “ £134 ”,
- (ii) for “£397” substitute “ £402 ”, and
- (iii) for “£656” substitute “ £664 ”; and
- (b) in column (3) (fees for other applications)—
- (i) for “£326” substitute “ £330 ”,
- (ii) for “£585” substitute “ £592 ”, and
- (iii) for “£859” substitute “ £869 ”.
Amendment of regulation 3 of the Devices Regulations
3
In regulation 3 of the Devices Regulations (fees)—
- (a) in paragraph (1)(a), for “£3,533” substitute “ £3,575 ”;
- (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
4
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Amendment of Part IA of the General Fees Regulations
5
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Amendment of regulation 4 of the General Fees Regulations
6
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Amendment of regulation 5 of the General Fees Regulations
7
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Amendment of regulation 7 of the General Fees Regulations
8
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Amendment of regulation 8 of the General Fees Regulations
9
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Amendment of regulation 13 of the General Fees Regulations
10
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Amendment of Part VII of the General Fees Regulations
11
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Amendment of Part I of Schedule 1 to the General Fees Regulations
12
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Amendment of Schedule 2 to the General Fees Regulations
13
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Amendment of Schedule 5 to the General Fees Regulations
14
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Amendment of the General Fees Regulations
15
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SCHEDULE
| Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
| Provision in the General Regulations | Subject matter | Old amount | New amount |
| Regulation 3B | Capital fees for pre-application meetings | ||
| Paragraph (a) | £1,000 | £1,012 | |
| Paragraph (b) | £1,330 | £1,346 | |
| Paragraph (c) | £1,670 | £1,690 | |
| Paragraph (d) | £2,000 | £2,024 | |
| Regulation 6 | Applications for certificates by Exporters of medicinal products | ||
| Paragraph (1)(a) | £117 | £118 | |
| Paragraph (1)(b) | £52 | £53 | |
| Paragraph (1)(c)(i) | £52 | £53 | |
| Regulation 10 | Renewal of clinical trial certificates | £2,199 | £2,225 |
| Regulation 11(1) | Renewals of certain manufacturer’s licences | £125 | £127 |
| Part II of Schedule 1 | Capital fees for applications for authorizations, licences and certificates | ||
| In column 2 of the Table in paragraph 1(1) | |||
| Entry 1(a) | £25,835 | £25,690 | |
| Entry 1(b) | £55,441 | £56,106 | |
| Entry 1(c) | £79,630 | £80,586 | |
| Entry 2(a) | £15,392 | £15,577 | |
| Entry 2(b) | £21,990 | £22,254 | |
| Entry 3(a) | £5,640 | £5,708 | |
| Entry 3(b) | £8,063 | £8,160 | |
| Entry 4 | £2,199 | £2,225 | |
| Entry 5 | £1,465 | £1,483 | |
| Entry 6 | £362 | £366 | |
| Paragraph 1A(1) | £6,480 | £6,558 | |
| Paragraph 4(4)(b) | £494 | £500 | |
| Paragraph 5(1)(a) | £140 | £142 | |
| Paragraph 5(1)(b) | £265 | £268 | |
| Paragraph 5(1)(c) | £2,415 | £2,444 | |
| Paragraph 6(1) | £949 | £1,402 | |
| Paragraph 6(2) | £698 | £600 | |
| Paragraph 6(4) | £306 | £310 | |
| Paragraph 7 | £17,215 | £17,422 | |
| Part IIA of Schedule 1 | Capital fees for assistance in obtaining marketing authorizations in other EEA states | ||
| Paragraph 2(a)(i) | £33,992 | £34,400 | |
| Paragraph 2(a)(ii) | £22,328 | £22,596 | |
| Paragraph 2(b)(i) | £8,748 | £8,853 | |
| Paragraph 2(b)(ii) | £5,832 | £5,902 | |
| Paragraph 2(c)(i) | £3,499 | £3,541 | |
| Paragraph 2(c)(ii) | £2,916 | £2,951 | |
| Paragraph 2(d) | £2,094 | £2,119 | |
| Part III of Schedule 1 | Capital fees for applications for variations of authorizations, licences and certificates | ||
| Paragraph 2(a) | £140 | £142 | |
| Paragraph 2(aa) | £214 | £224 | |
| Paragraph 2(b) | £494 | £590 | |
| Paragraph 2(c) | £7,326 | £6,672 | |
| Paragraph 2(cc) | £21,990 | £22,254 | |
| Paragraph 2(d) | £6,480 | £6,558 | |
| Paragraph 3(a) | £220 | £222 | |
| Paragraph 3(aa) | £334 | £442 | |
| Paragraph 3(b) | £598 | £714 | |
| Paragraph 3(c) | £11,432 | £11,568 | |
| Paragraph 3(d) | £30,738 | £31,106 | |
| Paragraph 5A(1) | £494 | £500 | |
| Paragraph 6(a) | £140 | £142 | |
| Paragraph 6(b) | £6,480 | £6,558 | |
| Paragraph 6(c) | £292 | £296 | |
| Paragraph 7(a) | £132 | £200 | |
| Paragraph 7(b) | £264 | £400 | |
| Paragraph 8 | £132 | £200 | |
| Paragraph 9 | £304 | £378 | |
| Paragraph 10 | £132 | £200 | |
| Paragraph 11 | £216 | £218 | |
| Paragraph 15(a)(ii) | £494 | £500 | |
| Paragraph 15(a)(iii) | £247 | £250 | |
| Paragraph 15(b)(ii) | £247 | £250 | |
| Part IIIA of Schedule 1 | Capital fees for assessment of labels and leaflets | ||
| Paragraph 2(a) | £350 | £319 | |
| Paragraph 2(b) | £270 | £273 | |
| Part IV of Schedule 1 | 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 | ||
| Paragraph 1(a) | £7,327 | £7,415 | |
| Paragraph 1(b) | £598 | £605 | |
| Paragraph 2(a)(ii) | £598 | £605 | |
| Paragraph 2(b)(ii) | £299 | £303 | |
| Schedule 2 | Fees for inspections | ||
| Paragraph 2(a)(i) | £2,291 | £2,481 | |
| Paragraph 2(a)(ii) | £4,249 | £4,601 | |
| Paragraph 2(a)(iii) | £5,132 | £5,557 | |
| Paragraph 2(a)(iv) | £8,796 | £9,525 | |
| Paragraph 2(b)(i) | £2,492 | £2,698 | |
| Paragraph 2(b)(ii) | £5,132 | £5,557 | |
| Paragraph 2(b)(iii) | £8,061 | £8,729 | |
| Paragraph 2(b)(iv) | £14,659 | £15,873 | |
| Paragraph 2(c)(i) | £879 | £952 | |
| Paragraph 2(c)(ii) | £2,460 | £2,664 | |
| Paragraph 2(c)(iii) | £3,677 | £3,982 | |
| Paragraph 2(c)(iv) | £6,888 | £7,459 | |
| Paragraph 2(cc)(i) | £1,500 | £1,518 | |
| Paragraph 2(cc)(ii) | £4,000 | £4,048 | |
| Paragraph 2(cc)(iii) | £7,500 | £7,590 | |
| Paragraph 2(d) | £166 | £168 | |
| Paragraph 5(1) | £461 | £499 | |
| Paragraph 5(1) | £1,011 | £1,095 | |
| In column 2 of the Table in paragraph 5(3) | |||
| Entry for “None” | £1,011 | £1,023 | |
| Entry for “1 to 4” | £1,211 | £1,226 | |
| Entry for “5 to 20” | £2,011 | £2,035 | |
| Entry for “21 to 100” | £4,011 | £4,059 | |
| Entry for “101 to 500” | £9,011 | £9,119 | |
| Entry for “More than 500” | £16,011 | £16,203 | |
| Paragraph 5A(a) | £3,500 | £3,542 | |
| Paragraph 5A(b) | £5,000 | £5,060 | |
| Paragraph 5A(c) | £10,000 | £10,120 | |
| Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | ||
| In column 2 of the Table in paragraph 1 | |||
| Entry 1 | £14,241 | £14,768 | |
| Entry 2(a) | £5,863 | £6,080 | |
| Entry 2(b)(i) | £1,467 | £1,521 | |
| Entry 2(b)(ii) | £732 | £759 | |
| Entry 2(b)(iii) | £238 | £247 | |
| Entry 2(c)(i) | £642 | £666 | |
| Entry 2(c)(ii) | £321 | £333 | |
| Entry 2(c)(iii) | £119 | £123 | |
| Entry 2(d)(i) | £265 | £275 | |
| Entry 2(d)(ii) | £132 | £137 | |
| Entry 2(d)(iii) | £58 | £60 | |
| Entry 2(e) | £72 | £75 | |
| Paragraph 2(a) | £326 | £338 | |
| Paragraph 2(b) | £161 | £167 | |
| Paragraph 2(c) | £68 | £71 | |
| Paragraph 3(a) | £5,863 | £6,080 | |
| Paragraph 3(b) | £3,959 | £4,105 | |
| Paragraph 7 | £293 | £304 | |
| Paragraph 8(1) | £180 | £187 | |
| Paragraph 8(2) | £108 | £112 |
Signed
Signed by authority of the Secretary of State for Health
Warner — Parliamentary Under Secretary of State, — Department of Health — 2004-03-09
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
GowdyD. C. — Permanent Secretary, — Department of Health, Social Services and Public Safety — 2004-03-08
Sealed with the Official Seal of the Department of Agriculture and Rural Development
Pat Toal — Permanent Secretary, — Department of Agriculture and Rural Development — 2004-03-09
We consent,
Derek Twigg — Nick Ainger — Two of the Lords Commissioners of Her Majesty’s Treasury — 2004-03-10
Explanatory note
(This note is not part of the Regulations)
Footnotes
[^f00001]: 1972 c. 68.
[^f00002]: S.I. 1972/1811.
[^f00003]: 1973 c. 51.
[^f00004]: 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.
[^f00005]: 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).
[^f00006]: 1968 c. 67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.
[^f00007]: S.I. 1995/449; as amended by S.I. 1998/574, 1999/566, 2000/592, 2001/795, 2002/236 and 542, and 2003/625.
[^f00008]: 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.
[^f00009]: 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.
[^f00010]: As amended by regulation 2(2) of S.I. 2003/625.
[^f00011]: As amended by regulation 2(3) of S.I. 2003/625.
[^f00012]: As amended by regulation 2(4) of S.I. 2003/625.
[^f00013]: As amended by regulation 3 of S.I. 2003/625.
[^f00014]: The definition of “concerned member State” was inserted by regulation 2 of S.I. 2000/3031.
[^f00015]: S.I. 1971/972; relevant amending instruments are S.I. 1977/1053 and 1992/2846.
[^f00016]: The definition of “parallel import licence” was inserted by regulation 5(1)(c) of S.I. 2001/795.
[^f00017]: Part 1A was inserted by regulation 4(3) of S.I. 2003/625 and amended by regulation 9 of S.I. 2003/2321.
[^f00018]: S.I. 1999/3106.
[^f00019]: 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.
[^f00020]: OJ No. L 193, 17.7.1991, p. 30.
[^f00021]: OJ No. L 262, 14.10.1993, p. 22.
[^f00022]: Paragraph 1A was inserted by regulation 13(1) and (2) of S.I. 2003/2321.
[^f00023]: 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.
[^f00024]: Paragraphs 1A and 4(4) of Part II of Schedule 1 were inserted by regulation 5(5) of S.I. 2002/542.
[^f00025]: Part IIA was inserted by regulation 6 of S.I. 2000/2031.
[^f00026]: 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. 2002/542
[^f00027]: Part IIIA of Schedule 1 was inserted by regulation 4(1) and (6) of S.I. 2003/625.
[^f00028]: Part IV of Schedule 1 was inserted by regulation 5(7) of S.I. 2002/542.
[^f00029]: Paragraph 5(3) was inserted by regulation 4(1) and (7)(e)(ii) of S.I. 2003/625.
[^f00030]: Paragraph 5A was inserted by regulation 4(1) and (7)(f) of S.I. 2003/625.
[^f00031]: OJ No. L 297, 13.10.1992, p. 8.
[^f00032]: See articles 1(5), 13 to 16, 53, 68, 69, 85, 100, 119 and 124.
[^f00033]: OJ No. L 169, 12.7.1993, p. 1; amended by Directive 98/79/EC (OJ No. L 331, 7.12.1998, p. 1).
[^f00034]: OJ No. L 159, 27.6.2003, p. 46.
[^f00035]: OJ No. L 311, 28.11.2001, p. 67.
Editorial notes
[^c5310261]: 1972 c. 68.
[^c5310271]: S.I. 1972/1811.
[^c5310281]: 1973 c. 51.
[^c5310291]: 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.
[^c5310301]: 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).
[^c5310311]: 1968 c. 67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.
[^c5310321]: S.I. 1995/449; as amended by S.I. 1998/574, 1999/566, 2000/592, 2001/795, 2002/236 and 542, and 2003/625.
[^c5310331]: 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.
[^c5310341]: 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.
[^c5310351]: As amended by regulation 2(2) of S.I. 2003/625.
[^c5310361]: As amended by regulation 2(3) of S.I. 2003/625.
[^c5310371]: As amended by regulation 2(4) of S.I. 2003/625.
[^c5310381]: As amended by regulation 3 of S.I. 2003/625.
[^key-7d6b0b4bf3c6cecc0d484fcae798f3d3]: Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552), regs. 1, 48(1), Sch. 7 (with reg. 48(2))
[^key-42bec038b3358b21fd23926328589f8e]: Sch. revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552), regs. 1, 48(1), Sch. 7 (with reg. 48(2))
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