LegalizeThe Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003
Made: 11th March 2003
Laid before Parliament: 11th March 2003
Coming into force
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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 Devices Regulations
3
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Amendment of the General Fees Regulations
4
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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 6 | Applications for certificates by exporters of medicinal products | ||
| Paragraph (1)(a) | £108 | £117 | |
| Paragraph (1)(b) | £48 | £52 | |
| Paragraph (1)(c)(i) | £48 | £52 | |
| Paragraph (1)(c)(ii) | £24 | £26 | |
| Regulation 10 | Renewal of clinical trial certificates | £2,036 | £2,199 |
| Regulation 11(1) | Renewals of certain manufacturer’s licences | £116 | £125 |
| 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) | £24,431 | £25,835 | |
| Entry 1(b) | £52,260 | £55,441 | |
| Entry 1(c) | £74,657 | £79,630 | |
| Entry 2(a) | £14,252 | £15,392 | |
| Entry 2(b) | £20,361 | £21,990 | |
| Entry 3(a) | £5,222 | £5,640 | |
| Entry 3(b) | £7,466 | £8,063 | |
| Entry 4 | £2,036 | £2,199 | |
| Entry 5 | £1,356 | £1,465 | |
| Entry 6 | £335 | £362 | |
| Paragraph 1A(1) | £6,000 | £6,480 | |
| Paragraph 4(4)(b) | £458 | £494 | |
| Paragraph 5(1)(a) | £130 | £140 | |
| Paragraph 5(1)(b) | £245 | £265 | |
| Paragraph 5(1)(c) | £2,236 | £2,415 | |
| Paragraph 6(1) | £879 | £949 | |
| Paragraph 6(2) | £646 | £698 | |
| Paragraph 6(4) | £283 | £306 | |
| Paragraph 7 | £15,940 | £17,215 | |
| Part IIA of Schedule 1 | Capital fees for assistance in obtaining marketing authorizations in other EEA states | ||
| Paragraph 2(a)(i) | £32,400 | £33,992 | |
| Paragraph 2(a)(ii) | £21,600 | £22,328 | |
| Paragraph 2(b)(i) | £8,100 | £8,748 | |
| Paragraph 2(b)(ii) | £5,400 | £5,832 | |
| Paragraph 2(c)(i) | £3,240 | £3,499 | |
| Paragraph 2(c)(ii) | £2,700 | £2,916 | |
| Paragraph 2(d) | £1,939 | £2,094 | |
| Part III of Schedule 1 | Capital fees for applications for variations of authorizations, licences and certificates | ||
| Paragraph 2(a) | £198 | £214 | |
| Paragraph 2(b) | £458 | £494 | |
| Paragraph 2(c) | £6,784 | £7,326 | |
| Paragraph 2(d) | £6,000 | £6,480 | |
| Paragraph 3(a) | £310 | £334 | |
| Paragraph 3(b) | £554 | £598 | |
| Paragraph 3(c) | £10,586 | £11,432 | |
| Paragraph 5A(1) | £458 | £494 | |
| Paragraph 6(a) | £130 | £140 | |
| Paragraph 6(b) | £6,000 | £6,480 | |
| Paragraph 6(c) | £270 | £292 | |
| Paragraph 7(a) | £122 | £132 | |
| Paragraph 7(b) | £245 | £264 | |
| Paragraph 8 | £122 | £132 | |
| Paragraph 9 | £282 | £304 | |
| Paragraph 10 | £122 | £132 | |
| Paragraph 11 | £200 | £216 | |
| Paragraph 12 | £103 | £110 | |
| Paragraph 15(a)(ii) | £458 | £494 | |
| Paragraph 15(a)(iii) | £229 | £247 | |
| Paragraph 15(b)(ii) | £229 | £247 | |
| 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) | £6,784 | £7,327 | |
| Paragraph 1(b) | £554 | £598 | |
| Paragraph 2(a)(ii) | £554 | £598 | |
| Paragraph 2(b)(ii) | £277 | £299 | |
| Schedule 2 | Fees for inspections | ||
| Paragraph 2(a)(i) | £2,121 | £2,291 | |
| Paragraph 2(a)(ii) | £3,934 | £4,249 | |
| Paragraph 2(a)(iii) | £4,752 | £5,132 | |
| Paragraph 2(a)(iv) | £8,144 | £8,796 | |
| Paragraph 2(b)(i) | £2,307 | £2,492 | |
| Paragraph 2(b)(ii) | £4,752 | £5,132 | |
| Paragraph 2(b)(iii) | £7,464 | £8,061 | |
| Paragraph 2(b)(iv) | £13,573 | £14,659 | |
| Paragraph 2(c)(i) | £814 | £879 | |
| Paragraph 2(c)(ii) | £2,278 | £2,460 | |
| Paragraph 2(c)(iii) | £3,405 | £3,677 | |
| Paragraph 2(c)(iv) | £6,378 | £6,888 | |
| Paragraph 2(d) | £154 | £166 | |
| Paragraph 5(1) | £427 | £461 | |
| Paragraph 5(1) | £936 | £1,011 | |
| Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | ||
| In column 2 of the Table in paragraph 1 | |||
| Entry 1 | £13,186 | £14,241 | |
| Entry 2(a) | £5,429 | £5,863 | |
| Entry 2(b)(i) | £1,358 | £1,467 | |
| Entry 2(b)(ii) | £678 | £732 | |
| Entry 2(b)(iii) | £220 | £238 | |
| Entry 2(c)(i) | £594 | £642 | |
| Entry 2(c)(ii) | £297 | £321 | |
| Entry 2(c)(iii) | £110 | £119 | |
| Entry 2(d)(i) | £245 | £265 | |
| Entry 2(d)(ii) | £122 | £132 | |
| Entry 2(d)(iii) | £54 | £58 | |
| Entry 2(e) | £67 | £72 | |
| Paragraph 2(a) | £302 | £326 | |
| Paragraph 2(b) | £149 | £161 | |
| Paragraph 2(c) | £63 | £68 | |
| Paragraph 3(a) | £5,429 | £5,863 | |
| Paragraph 3(b) | £3,666 | £3,959 | |
| Paragraph 7 | £271 | £293 | |
| Paragraph 8(1) | £167 | £180 | |
| Paragraph 8(2) | £100 | £108 |
Signed
Signed by authority of the Secretary of State for Health
Hunt — Parliamentary Under Secretary of State, — Department of Health — 2003-03-11
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 — 2003-03-04
Sealed with the Official Seal of the Department of Agriculture and Rural Development
P. J. Small — Permanent Secretary, — Department of Agriculture and Rural Development — 2003-03-07
We consent,
Nick Ainger — Philip Woolas — Two of the Lords Commissioners of Her Majesty’s Treasury — 2003-03-10
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); 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 article 2(1) of, and paragraph 1 of the Schedule to, S.I. 1999/3142 and article 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; amended by S.I.1998/574, 1999/566, 2000/592, 2001/795, 2002/236 and 542.
[^f00008]: S.I. 1995/1116; amended by S.I. 1996/683, 1998/574, 1999/566, 2000/592 and 3031, 2001/795 and 2002/236 and 542.
[^f00009]: S.I.1994/105; amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2000/592, 2001/795, 2002/236 and 542.
[^f00010]: As amended by regulation 2(3) of S.I. 2002/542.
[^f00011]: As amended by regulation 2(4) of S.I. 2002/542.
[^f00012]: As amended by regulation 2(5) of S.I. 2002/542.
[^f00013]: As amended by regulation 4 of S.I. 2002/542.
[^f00014]: See the definition of “the 2001 Directive” in regulation 2(1) as substituted by S.I. 2002/236.
[^f00015]: See Articles 2 and 3 of the Directive.
[^f00016]: OJ No. L193, 17.7.91, p. 30.
[^f00017]: See the definition of “the 1994 Regulations” in regulation 2(1) of the General Fees Regulations.
[^f00018]: Paragraphs 1A and 4(4) of Part II of Schedule 1 were inserted by regulation 5(5) of S.I. 2002/542
[^f00019]: Part IIA was inserted by regulation 6 of S.I. 2000/2031.
[^f00020]: 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.
[^f00021]: Part IV of Schedule 1 was inserted by regulation 5(7) of S.I. 2002/542.
[^f00022]: OJ No. L 297, 13.10.1992, p. 8.
[^f00023]: See articles 1(5), 13 to 16, 53, 68, 69, 85, 100, 119 and 124.
[^f00024]: OJ No. L 169, 12.7.1993, p.1; amended by Directive 98/79/EC (OJ No. L 331, 7.12.1998, p. 1).
Editorial notes
[^key-059bd39ee21d6fbf6084345e6259af3b]: 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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