Citation, commencement and interpretation1
1
These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002 and shall come into force on 1st April 2002.
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;
“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M3; and
“the Marketing Authorisations Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 M4.
Amendment of the Homoeopathic Products Regulations2
1
In regulation 6 of the Homoeopathic Products Regulations (grant of a certificate), omit paragraph (b).
2
In regulation 9 of the Homoeopathic Products Regulations M5 (suspension and revocation), omit paragraph (3).
3
In regulation 14 of the Homoeopathic Products Regulations M6 (fees for variations of certificates)—
a
in paragraph (1)(a), for “£95” substitute “
£103
”
;
b
in paragraph (1)(b)(i), for “£95” substitute “
£103
”
;
c
in paragraph (1)(b)(ii), for “£45” substitute “
£51.50
”
;
d
in paragraph (2)(a), for “£185” substitute “
£200
”
;
e
in paragraph (2)(b)(i), for “£185” substitute “
£200
”
;
f
in paragraph (2)(b)(ii), for “£185” substitute “
£200
”
;
g
in paragraph (2)(b)(iii), for “£88” substitute “
£100
”
; and
h
in paragraph (2)(b)(iv), for “£44” substitute “
£50
”
.
4
In regulation 15(1) of the Homoeopathic Products Regulations M7 (fees payable by holders of certificates), for “£12” substitute “
£13
”
.
5
In the Table in Schedule 2 to the Homoeopathic Products Regulations M8 (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 “£113” substitute “
£122
”
,
ii
for “£341” substitute “
£368
”
, and
iii
for “£562” substitute “
£607
”
; and
b
in column (3) (fees for other applications)—
i
for “£280” substitute “
£302
”
,
ii
for “£502” substitute “
£542
”
, and
iii
for “£736” substitute “
£795
”
.
Amendment of the Marketing Authorisations Regulations3
1
The Marketing Authorisations Regulations are amended as follows.
2
In regulation 5 (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization), omit paragraph (2).
3
After regulation 5 (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization) insert the following regulation—
Classification of medicinal products5A
1
Each marketing authorization granted by the licensing authority on or after 1st April 2002 shall be granted subject to a condition that the medicinal product to which the authorization relates is to be available—
a
only on prescription;
b
only from a pharmacy; or
c
on general sale.
2
Where prior to 1st April 2002 a medicinal product is subject to a marketing authorization and that authorization contains a statement that it is to be available on one or more of the following bases—
a
only on prescription;
b
only from a pharmacy; or
c
on general sale,
it is a condition of the marketing authorization from 1st April 2002 that the product is to be available only on that basis or, as the case may be, those bases.
4
In regulation 6 (revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products), omit paragraph (8).
5
Regulation 8 (control of sale or supply of relevant medicinal products) is hereby revoked.
6
In paragraph 6(2) of Schedule 5 (labels), for head (a) substitute—
a
if the product would be subject to restrictions imposed under section 58 of the Act if it contained a higher proportion or level of any substance, except where the product is for external use only or contains any of the substances described in head (c) of this sub-paragraph, the words “Warning. Do not exceed the stated dose”;
Amendment of regulation 3 of the Devices Regulations4
In regulation 3 of the Devices Regulations M9 (fees)—
a
in paragraph (1)(a), for “£3,029” substitute “
£3,271
”
;
b
in paragraph (1)(b), for “£6,726” substitute “
£7,264
”
;
c
in paragraph (2)(a), for “£599” substitute “
£647
”
;
d
in paragraph (2)(b), for “£1,676” substitute “
£1,810
”
;
e
in paragraph (3)(a), for “£2,285” substitute “
£3,271
”
;
f
in paragraph (3)(b), for “£6,406” substitute “
£7,264
”
;
g
in paragraph (4)(a), for “£570” substitute “
£647
”
;
h
in paragraph (4)(b), for “£1,596” substitute “
£1,810
”
;
i
in paragraph (5)(a), for “£30,972” substitute “
£33,450
”
; and
j
in paragraph (5)(b), for “£7,690” substitute “
£8,305
”
.
Amendment of the General Fees RegulationsF15
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signed by authority of the Secretary of State for Health
We consent,