Citation, commencement and interpretation

1. —(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002 and shall come into force on 1st April 2002.

(2) In these Regulations—

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

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

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

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

Amendment of the Homoeopathic Products Regulations

2. —(1) In regulation 6 of the Homoeopathic Products Regulations (grant of a certificate), omit paragraph (b).

(2) In regulation 9 of the Homoeopathic Products Regulations (suspension and revocation), omit paragraph (3).

(3) In regulation 14 of the Homoeopathic Products Regulations (fees for variations of certificates)—

(a) in paragraph (1)(a), for “£95” substitute “ £103 ” ;

(b) in paragraph (1)(b)(i), for “£95” substitute “ £103 ” ;

(c) in paragraph (1)(b)(ii), for “£45” substitute “ £51.50 ” ;

(d) in paragraph (2)(a), for “£185” substitute “ £200 ” ;

(e) in paragraph (2)(b)(i), for “£185” substitute “ £200 ” ;

(f) in paragraph (2)(b)(ii), for “£185” substitute “ £200 ” ;

(g) in paragraph (2)(b)(iii), for “£88” substitute “ £100 ” ; and

(h) in paragraph (2)(b)(iv), for “£44” substitute “ £50 ” .

(4) In regulation 15(1) of the Homoeopathic Products Regulations (fees payable by holders of certificates), for “£12” substitute “ £13 ” .

(5) In the Table in Schedule 2 to the Homoeopathic Products Regulations (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 “£113” substitute “ £122 ” ,

(ii) for “£341” substitute “ £368 ” , and

(iii) for “£562” substitute “ £607 ” ; and

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

(i) for “£280” substitute “ £302 ” ,

(ii) for “£502” substitute “ £542 ” , and

(iii) for “£736” substitute “ £795 ” .

Amendment of the Marketing Authorisations Regulations

3. —(1) The Marketing Authorisations Regulations are amended as follows.

(2) In regulation 5 (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization), omit paragraph (2).

(3) After regulation 5 (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization) insert the following regulation—

“ Classification of medicinal products

5A. —(1) Each marketing authorization granted by the licensing authority on or after 1st April 2002 shall be granted subject to a condition that the medicinal product to which the authorization relates is to be available—

(a) only on prescription;

(b) only from a pharmacy; or

(c) on general sale.

(2) Where prior to 1st April 2002 a medicinal product is subject to a marketing authorization and that authorization contains a statement that it is to be available on one or more of the following bases—

(a) only on prescription;

(b) only from a pharmacy; or

(c) on general sale,

it is a condition of the marketing authorization from 1st April 2002 that the product is to be available only on that basis or, as the case may be, those bases. ” .

(4) In regulation 6 (revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products), omit paragraph (8).

(5)Regulation 8 (control of sale or supply of relevant medicinal products) is hereby revoked.

(6) In paragraph 6(2) of Schedule 5 (labels), for head (a) substitute—

“ (a) if the product would be subject to restrictions imposed under section 58 of the Act if it contained a higher proportion or level of any substance, except where the product is for external use only or contains any of the substances described in head (c) of this sub-paragraph, the words “Warning. Do not exceed the stated dose”; ” .

Amendment of regulation 3 of the Devices Regulations

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

(a) in paragraph (1)(a), for “£3,029” substitute “ £3,271 ” ;

(b) in paragraph (1)(b), for “£6,726” substitute “ £7,264 ” ;

(c) in paragraph (2)(a), for “£599” substitute “ £647 ” ;

(d) in paragraph (2)(b), for “£1,676” substitute “ £1,810 ” ;

(e) in paragraph (3)(a), for “£2,285” substitute “ £3,271 ” ;

(f) in paragraph (3)(b), for “£6,406” substitute “ £7,264 ” ;

(g) in paragraph (4)(a), for “£570” substitute “ £647 ” ;

(h) in paragraph (4)(b), for “£1,596” substitute “ £1,810 ” ;

(i) in paragraph (5)(a), for “£30,972” substitute “ £33,450 ” ; and

(j) in paragraph (5)(b), for “£7,690” substitute “ £8,305 ” .

Amendment of the General Fees Regulations

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Regulation 5(9)

SCHEDULE

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