The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004

Citation, commencement and interpretationU.K.

1.—(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004 and shall come into force on 1st April 2004.

(2) In these Regulations—

“the Devices Regulations” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 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

Amendment of the Homoeopathic Products RegulationsU.K.

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

(2) In regulation 14 M4 (fees for variations of certificates)—

(a)in paragraph (2)(a), for “£216” substitute “ £218 ”;

(b)in paragraph (2)(b)(i), for “£216” substitute “ £218 ”;

(c)in paragraph (2)(b)(ii), for “£216” substitute “ £218 ”;

(d)in paragraph (2)(b)(iii), for “£108” substitute “ £110 ”; and

(e)in paragraph (2)(b)(iv), for “£54” substitute “ £55 ”.

(3) In regulation 15(1) M5 (fees payable by holders of certificates), for “£14” substitute “ £15 ”.

(4) In the Table in Schedule 2 M6 (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 “£132” substitute “ £134 ”,

(ii)for “£397” substitute “ £402 ”, and

(iii)for “£656” substitute “ £664 ”; and

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

(i)for “£326” substitute “ £330 ”,

(ii)for “£585” substitute “ £592 ”, and

(iii)for “£859” substitute “ £869 ”.

Marginal Citations

M4As amended by regulation 2(2) of S.I. 2003/625.

M5As amended by regulation 2(3) of S.I. 2003/625.

M6As amended by regulation 2(4) of S.I. 2003/625.

Amendment of regulation 3 of the Devices RegulationsU.K.

3.  In regulation 3 of the Devices Regulations M7 (fees)—

(a)in paragraph (1)(a), for “£3,533” substitute “ £3,575 ”;

(b)in paragraph (1)(b), for “£8,234” substitute “ £8,333 ”;

(c)in paragraph (2)(a), for “£699” substitute “ £707 ”;

(d)in paragraph (2)(b), for “£1,955” substitute “ £1,978 ”;

(e)in paragraph (3)(a), for “£3,533” substitute “ £3,575 ”;

(f)in paragraph (3)(b), for “£8,234” substitute “ £8,333 ”;

(g)in paragraph (4)(a), for “£699” substitute “ £707 ”;

(h)in paragraph (4)(b), for “£1,955” substitute “ £1,978 ”;

(i)in paragraph (5)(a), for “£36,126” substitute “ £36,560 ”; and

(j)in paragraph (5)(b), for “£8,969” substitute “ £9,077 ”.

Marginal Citations

M7As amended by regulation 3 of S.I. 2003/625.

Amendment of regulation 2 of the General Fees RegulationsU.K.

F14.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of Part IA of the General Fees RegulationsU.K.

F15.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 4 of the General Fees RegulationsU.K.

F16.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 5 of the General Fees RegulationsU.K.

F17.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 7 of the General Fees RegulationsU.K.

F18.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 8 of the General Fees RegulationsU.K.

F19.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 13 of the General Fees RegulationsU.K.

F110.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of Part VII of the General Fees RegulationsU.K.

F111.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of Part I of Schedule 1 to the General Fees RegulationsU.K.

F112.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of Schedule 2 to the General Fees RegulationsU.K.

F113.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of Schedule 5 to the General Fees RegulationsU.K.

F114.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of the General Fees RegulationsU.K.

F115.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Signed by authority of the Secretary of State for Health

Warner

Parliamentary Under Secretary of State,

Department of Health

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

GowdyD. C.

Permanent Secretary,

Department of Health, Social Services and Public Safety

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

Pat Toal

Permanent Secretary,

Department of Agriculture and Rural Development

We consent,

Derek Twigg

Nick Ainger

Two of the Lords Commissioners of Her Majesty’s Treasury