Statutory Instruments
2004 No. 666
FEES AND CHARGES
MEDICINES
The 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
M1,M2,M3,M4,M5,M6 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—
M7 “ the Devices Regulations ” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 ;
M8 “ the General Fees Regulations ” means the Medicines (Products for Human Use—Fees) Regulations 1995 ; and
M9 “ 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.
M10 (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 ” .
M11 (3) In regulation 15(1) (fees payable by holders of certificates), for “£14” substitute “ £15 ” .
M12 (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
M13 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
F1 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Part IA of the General Fees Regulations
F1 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of regulation 4 of the General Fees Regulations
F1 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of regulation 5 of the General Fees Regulations
F1 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of regulation 7 of the General Fees Regulations
F1 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of regulation 8 of the General Fees Regulations
F1 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of regulation 13 of the General Fees Regulations
F1 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Part VII of the General Fees Regulations
F1 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Part I of Schedule 1 to the General Fees Regulations
F1 12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Schedule 2 to the General Fees Regulations
F1 13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Schedule 5 to the General Fees Regulations
F1 14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of the General Fees Regulations
F1 15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State,
Department of Health
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
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,
Derek Twigg
Nick Ainger
Two of the Lords Commissioners of Her Majesty’s Treasury
Regulation 15
F2 SCHEDULE
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .