The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006 and shall come into force on 1st April 2006.

(2) In these Regulations—

“the Devices Regulations” means the Medical Devices (Consultation Requirements)(Fees) Regulations1995(1);

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

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

Amendment of the General Fees Regulations

2.—(1) The General Fees Regulations are amended as follows.

(2) In each provision specified in the entries in column (1) of the Schedule to these Regulations (the content of which is described in column (2) of that Schedule), for the amount specified opposite that provision in column (3) of that Schedule substitute the amount specified opposite that provision in column (4) of that Schedule.

(3) In Part II of Schedule 1 (capital fees for applications for authorizations, licences and certificates) (4), in paragraph 5, omit sub-paragraphs (1)(aa) and (3).

(4) In Part III of Schedule 1 (capital fees for applications for variations of authorizations, licences and certificates) (5), in paragraph 7—

(a) in sub-paragraph (a), at the end, insert “and”; and

(b) omit sub-paragraph (aa).

(5) In Schedule 2 (fees for inspections) (6), in paragraph 2—

(a) in sub-paragraph (d), at the end, insert “and”; and

(b) omit sub-paragraph (e).

(6) In Part III of Schedule 3 (periodic fees for marketing authorizations and licences(7), for sub-paragraph (1) of paragraph 7, substitute—

“(1) The fee payable under regulation 14(3) in connection with the holding of a manufacturer’s licence shall be £356.”.

Amendment of the Homoeopathic Products Regulations

3.—(1) The Homoeopathic Products Regulations are amended as follows.

(2) In regulation 14 (fees for variations of certificates)—

(a) in paragraph (2)(a), for “£218” substitute “£226”;

(b) in paragraph (2)(b)(i), for “£218” substitute “£226”;

(c) in paragraph (2)(b)(ii), for “£218” substitute “£226”;

(d) in paragraph (2)(b)(iii), for “£110” substitute “£114”; and

(e) in paragraph (2)(b)(iv), for “£55” substitute “£57”.

(3) In the table in Schedule 2 (fees for applications for the grant of certificates of registration(8)—

(a) in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)—

(i) for “£134” substitute “£148”;

(ii) for “£402” substitute “£444”; and

(iii) for “£664” substitute “£734”; and

(b) in column (3) (fees for other applications)—

(i) for “£330” substitute “£365”;

(ii) for “£592” substitute “£654”;

(iii) for “£869” substitute “£960”.

Amendment of regulation 3 of the Devices Regulations

4.—(1) In regulation 3 of the Devices Regulations (fees)—

(a) in paragraph (1)(a), for “£3,575” substitute “£3,948”;

(b) in paragraph (1)(b), for “£8,333” substitute “£9,202”;

(c) in paragraph (2)(a), for “£707” substitute “£781”;

(d) in paragraph (2)(b), for “£1,978” substitute “£2,184”;

(e) in paragraph (3)(a), for “£3,575” substitute “£3,948”;

(f) in paragraph (3)(b), for “£8,333” substitute “£9,262”;

(g) in paragraph (4)(a), for “£707” substitute “£781”;

(h) in paragraph 4(b), for “£1,978” substitute “£2,184”;

(i) in paragraph (5)(a), for “£36,560” substitute “£40,374” and

(j) in paragraph (5)(b), for “£9,077” substitute “£10,024”.

Signed by authority of the Secretary of State for Health

Jane Kennedy

Minister of State,

Department of Health

26th February 2006

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety

Andrew McCormick

Permanent Secretary,

Department of Health, Social Services and Public Safety

23rd February 2006

Sealed with the Official Seal of the Department of Agriculture and Rural Development

Pat Toal

Permanent Secretary,

Department of Agriculture and Rural Development

23rd February 2006

We consent,

Gillian Merron and Tom Watson

Two of the Lords Commissioners of Her Majesty’s Treasury

27th February 2006