🔆 📖 ➕ 👤

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

M133. 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

F14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Part IA of the General Fees Regulations

F15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of regulation 4 of the General Fees Regulations

F16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of regulation 5 of the General Fees Regulations

F17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of regulation 7 of the General Fees Regulations

F18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of regulation 8 of the General Fees Regulations

F19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of regulation 13 of the General Fees Regulations

F110. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Part VII of the General Fees Regulations

F111. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Part I of Schedule 1 to the General Fees Regulations

F112. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 2 to the General Fees Regulations

F113. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 5 to the General Fees Regulations

F114. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of the General Fees Regulations

F115. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Status: There are currently no known outstanding effects for the The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004.
The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004 (2004/666)

Displaying information

Status of this instrument

footnotecommentarytransitional and savingsin force statusrelated provisionsgeo extentinsert/omitsource countin force adj
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Regs. 4-15 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F2Sch. revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
M11972 c. 68 .
M2S.I. 1972/1811 .
M31973 c. 51 .
M41971 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.
M5In the case of the Secretary of State, by virtue of articles 2(1) of, and paragraph 1 of the Schedule to, S.I. 1999/3142 and articles 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) .
M61968 c. 67 ; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.
M7S.I. 1995/449 ; as amended by S.I. 1998/574 , 1999/566 , 2000/592 , 2001/795 , 2002/236 and 542 , and 2003/625 .
M8S.I. 1995/1116 ; as amended by S.I. 1996/683 , 1998/574 , 1999/566 , 2000/592 and 3031 , 2001/795 , 2002/236 and 542 , and 2003/625 and 2321 .
M9S.I. 1994/105 ; as amended by S.I. 1994/899 , 1995/541 , 1996/482 , 1998/574 , 1999/566 , 2000/592 , 2001/795 , 2002/236 and 542 , and 2003/625 and 2321 .
M10As amended by regulation 2(2) of S.I. 2003/625 .
M11As amended by regulation 2(3) of S.I. 2003/625 .
M12As amended by regulation 2(4) of S.I. 2003/625 .
M13As amended by regulation 3 of S.I. 2003/625 .
Defined TermSection/ArticleIDScope of Application
the Devices Regulationsreg. 1.legTermPliVkz4S
the General Fees Regulationsreg. 1.legTermzybWuv0A
the Homoeopathic Products Regulationsreg. 1.legTermXFHwJCtX
This instrument is derived from the version at www.legislation.gov.uk. To see a list of all amendments (including any to be made) check the resources page for this instrument on their website. Note, the status of this instrument is given above.
This instrument is derived from the version at www.legislation.gov.uk. To see original commencement information, check the resources page associated with this instrument. n.b. commencement information for marked amendments is embedded in the relevant footnote.

Status of changes to instrument text

The list includes made instruments, both those in force and those yet to come into force. Typically, instruments that are not yet in force (hence their changes are not incorporated into the text above) are indicated by description 'not yet' in the changes made column.