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

Citation, commencement and interpretation U.K.

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 M1 ;

“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995 M2 ; and

“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M3 .

Marginal Citations

M1 S.I. 1995/449 relevant amending instrument is S.I. 2004/666.

M2 S.I. 1995/1116, as amended by S.I. 1996/683, 1998/574, 1999/566, 2000/592 and 3031, 2001/795, 2002/236 and 542, 2003/625 and 2321, 2004/666 and 1157, and 2005/1124 and 2797.

M3 S.I. 1994/105 as amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2000/592, 2001/795, 2003/236 and 2321, 2004/666 and 2005/2753.

Amendment of the General Fees Regulations U.K.

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) M4 , 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) M5 , 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) M6 , 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 M7 , 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.”.

Marginal Citations

M4 Sub-paragraphs (1)(aa) and (3) were inserted by S.I. 2005/2979.

M5 Part III of Schedule 1 was amended by S.I.1996/683, 1998/574, 1999/566, 2000/592, 2001/795, 2002/236 and 542, 2003/625 and 2321, 2004/666 and 1157 and 2005/2979.

M6 Sub-paragraph (e) was inserted by S.I. 2005/2979.

M7 Paragraph 7 was substituted by S.I. 2005/2979.

Amendment of the Homoeopathic Products Regulations U.K.

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 M8 —

(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 ”.

Marginal Citations

M8 As amended by S.I.1996/482 and S.I. 2005/2753.

Amendment of regulation 3 of the Devices Regulations U.K.

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