The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001

Citation, commencement and interpretation U.K.

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(1);

“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995(2);

“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(3);

“the Marketing Authorisations Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(4).

Amendment of the Marketing Authorisations Regulations U.K.

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(5) as adjusted by the Protocol signed at Brussels on 17th March 1993(6);”;

(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 U.K.

3.—(1) In regulation 1(2) of the Homoeopathic Products Regulations(7) (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(8) 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)(9) 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(10) (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 U.K.

4.  In regulation 3 of the Devices Regulations(11) (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 U.K.

F1 5.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Reg. 5 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))

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