Statutory Instruments
2006 No. 494
FEES AND CHARGES
MEDICINES
The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006
Made
27th February 2006
Laid before Parliament
3rd March 2006
Coming into force
1st April 2006
The Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971 or, as the case may be, the powers conferred by those provisions and now vested in them .
In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972 and section 56(1) and (2) of the Finance Act 1973. The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products .
The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.
In accordance with section 129(6) of the Medicines Act 1968 , the Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.
Citation, commencement and interpretation
1. —(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006 and shall come into force on 1st April 2006.
(2) In these Regulations—
“ the Devices Regulations ” means the Medical Devices (Consultation Requirements)(Fees) Regulations1995 ;
“ 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 General Fees Regulations
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Amendment of the Homoeopathic Products Regulations
3. —(1) The Homoeopathic Products Regulations are amended as follows.
(2) In regulation 14 (fees for variations of certificates)—
(a) in paragraph (2)(a), for “£218” substitute “ £226 ” ;
(b) in paragraph (2)(b)(i), for “£218” substitute “ £226 ” ;
(c) in paragraph (2)(b)(ii), for “£218” substitute “ £226 ” ;
(d) in paragraph (2)(b)(iii), for “£110” substitute “ £114 ” ; and
(e) in paragraph (2)(b)(iv), for “£55” substitute “ £57 ” .
(3) 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 “£134” substitute “ £148 ” ;
(ii) for “£402” substitute “ £444 ” ; and
(iii) for “£664” substitute “ £734 ” ; and
(b) in column (3) (fees for other applications)—
(i) for “£330” substitute “ £365 ” ;
(ii) for “£592” substitute “ £654 ” ;
(iii) for “£869” substitute “ £960 ” .
Amendment of regulation 3 of the Devices Regulations
4. —(1) In regulation 3 of the Devices Regulations (fees)—
(a) in paragraph (1)(a), for “£3,575” substitute “ £3,948 ” ;
(b) in paragraph (1)(b), for “£8,333” substitute “ £9,202 ” ;
(c) in paragraph (2)(a), for “£707” substitute “ £781 ” ;
(d) in paragraph (2)(b), for “£1,978” substitute “ £2,184 ” ;
(e) in paragraph (3)(a), for “£3,575” substitute “ £3,948 ” ;
(f) in paragraph (3)(b), for “£8,333” substitute “ £9,262 ” ;
(g) in paragraph (4)(a), for “£707” substitute “ £781 ” ;
(h) in paragraph 4(b), for “£1,978” substitute “ £2,184 ” ;
(i) in paragraph (5)(a), for “£36,560” substitute “ £40,374 ” and
(j) in paragraph (5)(b), for “£9,077” substitute “ £10,024 ” .
Signed by authority of the Secretary of State for Health
Jane Kennedy
Minister of State,
Department of Health
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
Andrew McCormick
Permanent Secretary,
Department of Health, Social Services and Public Safety
Sealed with the Official Seal of the Department of Agriculture and Rural Development
Pat Toal
Permanent Secretary,
Department of Agriculture and Rural Development
We consent,
Gillian Merron and Tom Watson
Two of the Lords Commissioners of Her Majesty's Treasury
Regulation 2(1)
SCHEDULE
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