LegalizeThe Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999
Made: 5th March 1999
Laid before Parliament: 8th March 1999
Coming into force: 1st April 1999
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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 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 |
| Regulation 6(1)(a) | £80 | £85 | |
| Regulation 6(1)(c)(ii) | £14 | £15 | |
| Regulation 10 | Renewals of clinical trial certificates | £1,500 | £1,575 |
| Regulation 11(1) | Renewals of certain manufacturers’ licences | £85 | £90 |
| 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) | £18,000 | £18,900 | |
| Entry 1(b) | £38,500 | £40,425 | |
| Entry 1(c) | £55,000 | £57,750 | |
| Entry 2(a) | £10,500 | £11,025 | |
| Entry 2(b) | £15,000 | £15,750 | |
| Entry 3(a) | £3,850 | £4,040 | |
| Entry 3(b) | £5,500 | £5,775 | |
| Entry 4 | £1,500 | £1,575 | |
| Entry 5 | £1,000 | £1,050 | |
| Entry 6 | £250 | £260 | |
| Paragraph 5(1)(a) | £95 | £100 | |
| Paragraph 5(1)(b) | £180 | £190 | |
| Paragraph 5(1)(c) | £1,650 | £1,730 | |
| Paragraph 6(1) | £650 | £680 | |
| Paragraph 6(2) | £475 | £500 | |
| Paragraph 6(4) | £210 | £220 | |
| Paragraph 7 | £11,600 | £12,180 | |
| 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) | £150 | £155 | |
| Paragraph 2(b) | £340 | £355 | |
| Paragraph 2(c) | £5,000 | £5,250 | |
| Paragraph 3(a) | £230 | £240 | |
| Paragraph 3(b) | £410 | £430 | |
| Paragraph 3(c) | £7,800 | £8,190 | |
| Paragraph 6(a) | £95 | £100 | |
| Paragraph 6(b) | £200 | £210 | |
| Paragraph 7(a) | £90 | £95 | |
| Paragraph 7(b) | £180 | £190 | |
| Paragraph 8 | £90 | £95 | |
| Paragraph 9 | £210 | £220 | |
| Paragraph 10 | £90 | £95 | |
| Paragraph 11 | £150 | £155 | |
| Paragraph 12 | £75 | £80 | |
| Schedule 2 | Fees for inspections | Fees for inspections | Fees for inspections |
| Paragraph 2(a)(i) | £1,560 | £1,640 | |
| Paragraph 2(a)(ii) | £2,900 | £3,045 | |
| Paragraph 2(a)(iii) | £3,500 | £3,675 | |
| Paragraph 2(a)(iv) | £6,000 | £6,300 | |
| Paragraph 2(b)(i) | £1,700 | £1,785 | |
| Paragraph 2(b)(ii) | £3,500 | £3,675 | |
| Paragraph 2(b)(iii) | £5,500 | £5,775 | |
| Paragraph 2(b)(iv) | £10,000 | £10,500 | |
| Paragraph 2(c)(i) | £600 | £630 | |
| Paragraph 2(c)(ii) | £1,680 | £1,764 | |
| Paragraph 2(c)(iii) | £2,510 | £2,635 | |
| Paragraph 2(c)(iv) | £4,700 | £4,935 | |
| Paragraph 2(d) | £115 | £120 | |
| Paragraph 5(1) | £315 | £330 | |
| Paragraph 5(1) | £690 | £725 | |
| 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 | £10,200 | £10,710 | |
| Entry 2(a) | £4,000 | £4,200 | |
| Entry 2(b)(i) | £1,000 | £1,050 | |
| Entry 2(b)(ii) | £500 | £525 | |
| Entry 2(b)(iii) | £165 | £170 | |
| Entry 2(c)(i) | £440 | £460 | |
| Entry 2(c)(ii) | £220 | £230 | |
| Entry 2(c)(iii) | £80 | £85 | |
| Entry 2(d)(i) | £180 | £190 | |
| Entry 2(d)(ii) | £90 | £95 | |
| Entry 2(d)(iii) | £40 | £42 | |
| Entry 2(e) | £50 | £52 | |
| Paragraph 2(a) | £225 | £235 | |
| Paragraph 2(b) | £110 | £115 | |
| Paragraph 2(c) | £45 | £48 | |
| Paragraph 3(a) | £4,000 | £4,200 | |
| Paragraph 3(b) | £2,700 | £2,835 | |
| Paragraph 7 | £200 | £210 | |
| Paragraph 8(1) | £125 | £130 | |
| Paragraph 8(2) | £75 | £78 |
Signed
Signed by authority of the Secretary of State for Health
Hayman — Parliamentary Under Secretary of State, — Department of Health — 25th February 1999
Signed by authority of the Secretary of State for Wales
Jon Owen Jones — Parliamentary Under Secretary of State, Welsh Office — 5th March 1999
Sam Galbraith — Parliamentary Under Secretary of State, Scottish Office — 25th February 1999
Jeff Rooker — Minister of State, Ministry of Agriculture, Fisheries and Food — 25th February 1999
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
D.C. Gowdy — Permanent Secretary — 1st March 1999.
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on
P. Small — Permanent Secretary — 24th February 1999.
We consent,
Bob Ainsworth — Jim Dowd — Two of the Lords Commissioners of Her Majesty’s Treasury — 3rd March 1999
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 the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388): see therefore section 1(1) of the 1968 Act, as so amended, 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 those Regulations.
[^f00005]: In the case of the Secretaries of State concerned with health in England and in Wales, by virtue of article 2(2) of and Schedule 1 to the Transfer of Functions (Wales) Order 1969; in the case of the Secretary of State concerned with agriculture in Wales, by virtue of article 2(3) of and Schedule 1 to the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern Ireland Departments, by virtue of section 40 of and Schedule 5 to the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of and paragraph 2(1)(b) of Schedule 1 to the Northern Ireland Act 1974 (c. 28).
[^f00006]: 1968 c. 67.
[^f00007]: S.I. 1995/1116; amended by S.I. 1996/683 and 1998/574.
[^f00008]: S.I. 1994/105; amended by S.I. 1995/541, 1996/482 and 1998/574.
[^f00009]: See regulation 2(3) of S.I. 1998/574.
[^f00010]: S.I. 1995/449; the relevant amending instrument is S.I. 1998/574.
[^f00011]: Inserted by regulation 5(4) of S.I. 1996/683.
[^f00012]: S.I. 1998/574.
[^f00013]: OJ No. L 297, 13.10.92, p.8.
[^f00014]: OJ No. L 169, 12.7.93, p.1.
Editorial notes
[^key-ac85f49a26b3f304418caf929deb4703]: 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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