Statutory Instruments
2001 No. 795
MEDICINES
FEES AND CHARGES
The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001
Made
8th March 2001
Laid before Parliament
9th March 2001
Coming into force
1st April 2001
The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972( 1 ) in relation to medicinal products( 2 ), 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( 3 ), the Secretary of State concerned with health in England, the Minister of Agriculture, Fisheries and Food, the Minister of Health, Social Services and Public Safety and the Minister 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( 4 ), or, as the case may be, powers conferred by those provisions and now vested in them( 5 ), 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( 6 ), as extended by section 1(3)(b) of the Medicines Act 1971, 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 and Miscellaneous Amendments) Regulations 2001 and shall come into force on 1st April 2001.
(2) In these Regulations—
“the Devices Regulations” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995( 7 );
“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995( 8 );
“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994( 9 );
“the Marketing Authorisations Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994( 10 ).
Amendment of the Marketing Authorisations Regulations
2. —(1) In regulation 1(2) of the Marketing Authorisations Regulations (interpretation)—
(a) after the definition of “Community marketing authorisation” there shall be inserted the following definition—
“ “ EEA State” means a contracting party to the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 ( 11 ) as adjusted by the Protocol signed at Brussels on 17th March 1993 ( 12 ) ; ” ;
(b) after the definition of “the EMEA” there shall be inserted the following definition—
“ “parallel import licence” means a United Kingdom marketing authorisation granted by the licensing authority under these Regulations in respect of a relevant medicinal product which is imported into the United Kingdom from another EEA state in accordance with the rules of Community law relating to parallel imports ” ;
(c) the definition of “parallel import” shall be omitted; and
(d) for the definition of “United Kingdom marketing authorisation” there shall be substituted the following definition—
“ “United Kingdom marketing authorisation” means a marketing authorisation granted by the licensing authority under these Regulations and includes a parallel import licence. ” .
(2) In regulation 4(1) of the Marketing Authorisations Regulations (applications for the grant, renewal or variation of a United Kingdom marketing authorisation), for the words “any provision of Community law affecting” there shall be substituted the words “the rules of Community law relating to”.
(3) In regulation 5 of the Marketing Authorisations Regulations (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorisation)—
(a) in paragraph (1), after the word “provisions” at each place where it occurs, there shall be inserted the words “and (where applicable) the rules of Community law relating to parallel imports”;
(b) in paragraph (2), after the words “every authorisation” there shall be inserted the words “, other than a parallel import licence,”; and
(c) in paragraph (4), after the words “the 1965 Directive” there shall be inserted the words “or in relation to a parallel import licence”.
Amendment of the Homoeopathic Products Regulations
3. —(1) In regulation 1(2) of the Homoeopathic Products Regulations( 13 ) (interpretation), in the definition of “standard variation”—
(a) at the end of paragraph (n) the word “or” shall be omitted;
(b) at the end of paragraph (o) there shall be inserted the word “or”; and
(c) after paragraph (o) there shall be inserted the following paragraph—
“ (p) a change following modification to the manufacturing authorisation. ” .
(2) In regulation 14( 14 ) of the Homoeopathic Products Regulations (fees for variations of certificates)—
(a) in paragraph (1)(a), for “£90” there shall be substituted “£95”;
(b) in paragraph (1)(b)(i), for “£90” there shall be substituted “£95”;
(c) in paragraph (2)(a), for “£176” there shall be substituted “£185”;
(d) in paragraph (2)(b)(i), for “£176” there shall be substituted “£185”; and
(e) in paragraph (2)(b)(ii), for “£176” there shall be substituted “£185”.
(3) In regulation 15(1)( 15 ) of the Homoeopathic Products Regulations (fees payable by holders of certificates), for “£11” there shall be substituted “£12”.
(4) In the Table in Schedule 2 to the Homoeopathic Products Regulations( 16 ) (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 “£108” there shall be substituted “£113”,
(ii) for “£325” there shall be substituted “£341”, and
(iii) for “£535” there shall be substituted “£562”; and
(b) in column (3) (fees for other applications)—
(i) for “£267” there shall be substituted “£280”,
(ii) for “£478” there shall be substituted “£502”, and
(iii) for “£701” there shall be substituted “£736”.
Amendment of regulation 3 of the Devices Regulations
4. In regulation 3 of the Devices Regulations( 17 ) (fees)—
(a) in paragraph (1)(a), for “£2,885” there shall be substituted “£3,029”;
(b) in paragraph (1)(b), for “£6,406” there shall be substituted “£6,726”;
(c) in paragraph (2)(a), for “£570” there shall be substituted “£599”;
(d) in paragraph (2)(b), for “£1,596” there shall be substituted “£1,676”;
(e) in paragraph (5)(a), for “£29,326” there shall be substituted “£30,972”; and
(f) in paragraph (5)(b), for “£7,324” there shall be substituted “£7,690”.
Amendment of the General Fees Regulations
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State,
Department of Health
Hayman
Minister of State, Ministry of Agriculture, Fisheries and Food
Bairbre de Brún
Minister of Health, Social Services and Public Safety
Bríd Rodgers
Minister of Agriculture and Rural Development
We consent,
Greg Pope
Jim Dowd
Two of the Lords Commissioners of Her Majesty’s Treasury
Regulation 5(14)
SCHEDULE
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
S.I. 1972/1811 .
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) , as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388 and by article 5 of, and the Schedule to, S.I. 1999/3142 ; see therefore section 1(1) of the 1968 Act, which contains a definition of “the Ministers” which is relevant to the powers being exercised in the making of these Regulations. See also regultion 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 authorisation under the 1994 Regulations.
In the case of the Secretary of State concerned with health in England, by virtue of articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142 ; in the case of the Minister of Agriculture, Fisheries and Food, by virtue of articles 2(2) and 5 of, and the Schedule to, S.I. 1999/3142 ; in the case of the Minister of Health, Social Services and Public Safety and the Minister of Agriculture and Rural Development, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) .
OJ No. L1, 3.1.1994, p.3.
OJ No. L1, 3.1.1994, p.572.
As amended by S.I. 1998/574 .
As amended by regulation 2(1) of S.I. 2000/592 .
As amended by regulation 2(2) of S.I. 2000/592 .
As amended by regulation 2(3) of S.I. 2000/592 .
As amended by regulation 3 of S.I. 2000/592 .
OJ No. L22, 9.2.1965, p.369.
OJ No. L147, 9.6.1975, p.1.
OJ No. L147, 9.6.1975, p.13.
OJ No. L142, 25.5.1989, p.14.
OJ No. L142, 25.5.1989, p.16.
OJ No. L181, 28.6.1989, p.44.
OJ No. L113, 30.4.1992, p.5.
OJ No. L113, 30.4.1992, p.8.
OJ No. L297, 13.10.1992, p.8.
OJ No. L214, 24.8.1993, p.1.
OJ No. L297, 13.10.1993, p.8.
OJ No. L169, 12.7.1993, p.1.