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).
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.”.
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”.
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