2004 No. 666
The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004
Made
Laid before Parliament
Coming into force
The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 M1 in relation to medicinal products M2, 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 M3, 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 M4, or, as the case may be, powers conferred by those provisions and now vested in them M5, 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 M6 with such organisations as appear to them to be representative of interests likely to be substantially affected, hereby make the following Regulations:
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.
In 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).
1968 c. 67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.
Citation, commencement and interpretation1
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—
“the Devices Regulations” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 M7;
“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995 M8; and
“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M9.
Amendment of the Homoeopathic Products Regulations2
1
The Homoeopathic Products Regulations are amended as follows.
2
In regulation 14 M10 (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
”
.
3
In regulation 15(1) M11
(fees payable by holders of certificates), for “£14” substitute “
£15
”
.
4
In the Table in Schedule 2 M12 (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 Regulations3
In regulation 3 of the Devices Regulations M13 (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 RegulationsF14
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Part IA of the General Fees RegulationsF15
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of regulation 4 of the General Fees RegulationsF16
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of regulation 5 of the General Fees RegulationsF17
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of regulation 7 of the General Fees RegulationsF18
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of regulation 8 of the General Fees RegulationsF19
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of regulation 13 of the General Fees RegulationsF110
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Part VII of the General Fees RegulationsF111
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Part I of Schedule 1 to the General Fees RegulationsF112
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Schedule 2 to the General Fees RegulationsF113
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of Schedule 5 to the General Fees RegulationsF114
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of the General Fees RegulationsF115
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signed by authority of the Secretary of State for Health
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
Sealed with the Official Seal of the Department of Agriculture and Rural Development
We consent,
F2SCHEDULE
Sch. 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))
F2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1972 c. 68.