LegalizeThe Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000
Made: 6th March 2000
Laid before Parliament: 7th March 2000
Coming into force: 1st April 2000
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Citation, commencement and interpretation
1
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Amendment of the Homoeopathic Products Regulations
2
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Amendment of regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995
3
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Amendment of the General Fees Regulations
4
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Revocation
5
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SCHEDULE
| Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
| Provision in the General Fees Regulations | Subject matter | Old amount | New amount |
| Regulation 6 | Applications for certificates by exporters of medicinal products | Applications for certificates by exporters of medicinal products | Applications for certificates by exporters of medicinal products |
| Paragraph (1)(a) | £85 | £96 | |
| Paragraph (1)(b) | £30 | £34 | |
| Paragraph (1)(c)(i) | £30 | £34 | |
| Paragraph (1)(c)(ii) | £15 | £17 | |
| Regulation 10 | Renewals of clinical trial certificates | £1,575 | £1,795 |
| Regulation 11(1) | Renewals of certain manufacturer’s licences | £90 | £102 |
| Part II of Schedule 1 | Capital fees for applications for authorizations, licences and certificates | Capital fees for applications for authorizations, licences and certificates | Capital fees for applications for authorizations, licences and certificates |
| In column 2 of the Table in paragraph 1(1) | In column 2 of the Table in paragraph 1(1) | In column 2 of the Table in paragraph 1(1) | In column 2 of the Table in paragraph 1(1) |
| Entry 1(a) | £18,900 | £21,545 | |
| Entry 1(b) | £40,425 | £46,085 | |
| Entry 1(c) | £57,750 | £65,835 | |
| Entry 2(a) | £11,025 | £12,568 | |
| Entry 2(b) | £15,750 | £17,955 | |
| Entry 3(a) | £4,040 | £4,605 | |
| Entry 3(b) | £5,775 | £6,584 | |
| Entry 4 | £1,575 | £1,795 | |
| Entry 5 | £1,050 | £1,196 | |
| Entry 6 | £260 | £296 | |
| Paragraph 5(1)(a) | £100 | £114 | |
| Paragraph 5(1)(b) | £190 | £216 | |
| Paragraph 5(1)(c) | £1,730 | £1,972 | |
| Paragraph 6(1) | £680 | £775 | |
| Paragraph 6(2) | £500 | £570 | |
| Paragraph 6(4) | £220 | £250 | |
| Paragraph 7 | £12,180 | £13,885 | |
| Part III of Schedule 1 | Capital fees for applications for variations of authorizations, licences and certificates | Capital fees for applications for variations of authorizations, licences and certificates | Capital fees for applications for variations of authorizations, licences and certificates |
| Paragraph 2(a) | £155 | £176 | |
| Paragraph 2(b) | £355 | £404 | |
| Paragraph 2(c) | £5,250 | £5,984 | |
| Paragraph 3(a) | £240 | £274 | |
| Paragraph 3(b) | £430 | £490 | |
| Paragraph 3(c) | £8,190 | £9,336 | |
| Paragraph 6(a) | £100 | £114 | |
| Paragraph 6(b) | £210 | £239 | |
| Paragraph 7(a) | £95 | £108 | |
| Paragraph 7(b) | £190 | £216 | |
| Paragraph 8 | £95 | £108 | |
| Paragraph 9 | £220 | £250 | |
| Paragraph 10 | £95 | £108 | |
| Paragraph 11 | £155 | £176 | |
| Paragraph 12 | £80 | £90 | |
| Schedule 2 | Fees for inspections | Fees for inspections | Fees for inspections |
| Paragraph 2(a)(i) | £1,640 | £1,870 | |
| Paragraph 2(a)(ii) | £3,045 | £3,470 | |
| Paragraph 2(a)(iii) | £3,675 | £4,190 | |
| Paragraph 2(a)(iv) | £6,300 | £7,182 | |
| Paragraph 2(b)(i) | £1,785 | £2,034 | |
| Paragraph 2(b)(ii) | £3,675 | £4,190 | |
| Paragraph 2(b)(iii) | £5,775 | £6,582 | |
| Paragraph 2(b)(iv) | £10,500 | £11,970 | |
| Paragraph 2(c)(i) | £630 | £718 | |
| Paragraph 2(c)(ii) | £1,764 | £2,010 | |
| Paragraph 2(c)(iii) | £2,635 | £3,003 | |
| Paragraph 2(c)(iv) | £4,935 | £5,625 | |
| Paragraph 2(d) | £120 | £136 | |
| Paragraph 5(1) | £330 | £376 | |
| Paragraph 5(1) | £725 | £826 | |
| Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | Periodic fees for marketing authorizations and licences | Periodic fees for marketing authorizations and licences |
| In column 2 of the Table in paragraph 1 | In column 2 of the Table in paragraph 1 | In column 2 of the Table in paragraph 1 | In column 2 of the Table in paragraph 1 |
| Entry 1 | £10,710 | £12,209 | |
| Entry 2(a) | £4,200 | £4,788 | |
| Entry 2(b)(i) | £1,050 | £1,197 | |
| Entry 2(b)(ii) | £525 | £598 | |
| Entry 2(b)(iii) | £170 | £194 | |
| Entry 2(c)(i) | £460 | £524 | |
| Entry 2(c)(ii) | £230 | £262 | |
| Entry 2(c)(iii) | £85 | £97 | |
| Entry 2(d)(i) | £190 | £216 | |
| Entry 2(d)(ii) | £95 | £108 | |
| Entry 2(d)(iii) | £42 | £48 | |
| Entry 2(e) | £52 | £59 | |
| Paragraph 2(a) | £235 | £268 | |
| Paragraph 2(b) | £115 | £131 | |
| Paragraph 2(c) | £48 | £55 | |
| Paragraph 3(a) | £4,200 | £4,788 | |
| Paragraph 3(b) | £2,835 | £3,232 | |
| Paragraph 7 | £210 | £239 | |
| Paragraph 8(1) | £130 | £148 | |
| Paragraph 8(2) | £78 | £89 |
Signed
Signed by authority of the Secretary of State for Health
Hunt — Parliamentary Under Secretary of State, — Department of Health — 2000-03-01
Hayman — Minister of State, Ministry of Agriculture, Fisheries and Food — 2000-03-06
D.C. Gowdy — Permanent Secretary, — Department of Health, Social Services and Public Safety — 2000-03-06
P. Small — Permanent Secretary, — Department of Agriculture and Rural Development — 2000-03-03
We consent,
Bob Ainsworth — Greg Pope — Two of the Lords Commissioners of Her Majesty’s Treasury — 2000-03-06
Explanatory note
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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), as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388 and by article 5 of, and the Schedule to, S.I. 1999/3142; see therefore section 1(1) of the 1968 Act, 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 concerned with health in England, by virtue of articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; in the case of the Minister of Agriculture, Fisheries and Food, by virtue of articles 2(2) and 5 of, and the Schedule to, S.I. 1999/3142; in the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, 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) 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).
[^f00006]: 1968 c. 67.
[^f00007]: S.I. 1995/1116; amended by S.I. 1996/683, 1998/574 and 1999/566.
[^f00008]: S.I. 1994/105; amended by S.I. 1995/541, 1996/482, 1998/574 and 1999/566.
[^f00009]: As amended by regulation 2(3) of S.I. 1998/574 and regulation 2(1) of S.I. 1999/566.
[^f00010]: As amended by regulation 2(4) of S.I. 1998/574.
[^f00011]: As amended by regulation 2(2) of S.I. 1999/566.
[^f00012]: S.I. 1995/449; as amended by regulation 3 of S.I. 1999/566.
[^f00013]: As amended by regulation 2 of S.I. 1996/683.
[^f00014]: O.J. No. L18, 22.1.2000, p.1.
[^f00015]: O.J. No. L147, 9.6.1975, p.1. This Directive has been amended by Council Directive 95/319/EEC (O.J. No. L147, 9.6.1975, p.13), Council Directive 83/570/EEC (O.J. No. L332, 28.11.1983, p.1), Council Directive 87/19/EEC (O.J. No. L15, 17.1.1987, p.31), Council Directive 89/341/EEC (O.J. No. L142, 25.5.1989, p.11), Commission Directive 91/507/EEC (O.J. No. L270, 26.9.1991, p.32), Council Directive 93/39/EEC (O.J. No. L214, 24.8.93, p.22), Commission Directive 1999/82/EC (O.J. No. L243, 15.9.1999, p.7) and Commission Directive 1999/83/EC (O.J. No. L243, 15.9.1999, p.9).
[^f00016]: As amended by regulation 6(1) of S.I. 1996/683.
[^f00017]: As amended by regulation 6(3) of S.I. 1996/683.
[^f00018]: S.I. 1999/566.
[^f00019]: O.J. No. L297, 13.10.92, p.8.
[^f00020]: O.J. No. L169, 12.7.93, p.1.
Editorial notes
[^key-4f9e27e6bda09e30e1d2f5e1dfcec6a1]: Regulations revoked (1.4.2013) by The Medicines (Products for Human Use) (Fees) Regulations 2013 (S.I. 2013/532), reg. 1(2), Sch. 9
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