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 M1;
“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995 M2; and
“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M3.
Amendment of the Homoeopathic Products Regulations2
1
The Homoeopathic Products Regulations are amended as follows.
2
In regulation 14 M4 (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) M5
(fees payable by holders of certificates), for “£14” substitute “
£15
”
.
4
In the Table in Schedule 2 M6 (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 M7 (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,