LegalizeThe Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002
Made: 11th March 2002
Laid before Parliament: 11th March 2002
Coming into force: 1st April 2002
The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products, in exercise of the powers conferred upon him by the said section 2(2), the Secretary of State, with the consent of the Treasury, in exercise of the powers conferred upon him by section 56(1) and (2) of the Finance Act 1973, the Secretary of State concerned with health in England, the Minister of Agriculture, Fisheries and Food, the Minister of Health, Social Services and Public Safety and the Minister of Agriculture and Rural Development, acting jointly and with the consent of the Treasury, in exercise of powers conferred upon them by section 1(1) and (2) of the Medicines Act 1971, or, as the case may be, powers conferred by those provisions and now vested in them, and in each case in exercise of all other powers respectively enabling them in that behalf, after consultation in accordance with section 129(6) of the Medicines Act 1968, as extended by section 1(3)(b) of the Medicines Act 1971, with such organisations as appear to them to be representative of interests likely to be substantially affected, hereby make the following Regulations:—
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—
(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
5
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SCHEDULE
| Column (1) Provision in the General Regulations | Column (2) Subject matter | Column (3) Old amount | Column (4) New amount |
|---|---|---|---|
| Regulation 6 | Applications for certificates by exports of medicinal products | ||
| Paragraph (1)(a) | £100 | £108 | |
| Paragraph (1)(b) | £44 | £48 | |
| Paragraph (1)(c)(i) | £44 | £48 | |
| Paragraph (1)(c)(ii) | £22 | £24 | |
| Regulation 10 | Renewal of clinical trial certificates | £1,885 | £2,036 |
| Regulation 11(1) | Renewals of certain manufacturer’s licences | £107 | £116 |
| Part II of Schedule I | Capital fees for applications for authorizations, licences and certificates | ||
| In column 2 of the Table in paragraph 1(1) | |||
| Entry 1(a) | £22,622 | £24,431 | |
| Entry 1(b) | £48,389 | £52,260 | |
| Entry 1(c) | £69,127 | £74,657 | |
| Entry 2(a) | £13,196 | £14,252 | |
| Entry 2(b) | £18,853 | £20,361 | |
| Entry 3(a) | £4,835 | £5,222 | |
| Entry 3(b) | £6,913 | £7,466 | |
| Entry 4 | £1,885 | £2,036 | |
| Entry 5 | £1,256 | £1,356 | |
| Entry 6 | £310 | £335 | |
| Paragraph 5(1)(a) | £120 | £130 | |
| Paragraph 5(1)(b) | £227 | £245 | |
| Paragraph 5(1)(c) | £2,070 | £2,236 | |
| Paragraph 6(1) | £814 | £879 | |
| Paragraph 6(2) | £598 | £646 | |
| Paragraph 6(4) | £262 | £283 | |
| Paragraph 7 | £14,579 | £15,940 | |
| Part IIA of Schedule 1 | Capital fees for assistance in obtaining marketing authorizations in other EEA states | ||
| Paragraph 2(a)(i) | £30,000 | £32,400 | |
| Paragraph 2(a)(ii) | £20,000 | £21,600 | |
| Paragraph 2(b)(i) | £7,500 | £8,100 | |
| Paragraph 2(b)(ii) | £5,000 | £5,400 | |
| Paragraph 2(c)(i) | £3,000 | £3,240 | |
| Paragraph 2(c)(ii) | £2,500 | £2,700 | |
| Paragraph 2(d) | £1,795 | £1,939 | |
| Part III of Schedule 1 | Capital fees for applications for variations of authorizations, licences and certificates | ||
| Paragraph 2(a) | £184 | £198 | |
| Paragraph 2(b) | £424 | £458 | |
| Paragraph 2(c) | £6,282 | £6,784 | |
| Paragraph 3(a) | £288 | £310 | |
| Paragraph 3(b) | £514 | £554 | |
| Paragraph 3(c) | £9,802 | £10,586 | |
| Paragraph 6(a) | £120 | £130 | |
| Paragraph 7(a) | £113 | £122 | |
| Paragraph 7(b) | £227 | £245 | |
| Paragraph 8 | £113 | £122 | |
| Paragraph 9 | £262 | £282 | |
| Paragraph 10 | £113 | £122 | |
| Paragraph 11 | £185 | £200 | |
| Paragraph 12 | £95 | £103 | |
| Schedule 2 | Fees for inspections | ||
| Paragraph 2(a)(i) | £1,964 | £2,121 | |
| Paragraph 2(a)(ii) | £3,643 | £3,934 | |
| Paragraph 2(a)(iii) | £4,400 | £4,752 | |
| Paragraph 2(a)(iv) | £7,541 | £8,144 | |
| Paragraph 2(b)(i) | £2,136 | £2,307 | |
| Paragraph 2(b)(ii) | £4,400 | £4,752 | |
| Paragraph 2(b)(iii) | £6,911 | £7,464 | |
| Paragraph 2(b)(iv) | £12,568 | £13,573 | |
| Paragraph 2(c)(i) | £754 | £814 | |
| Paragraph 2(c)(ii) | £2,110 | £2,278 | |
| Paragraph 2(c)(iii) | £3,153 | £3,405 | |
| Paragraph 2(c)(iv) | £5,906 | £6,378 | |
| Paragraph 2(d) | £143 | £154 | |
| Paragraph 5(1) | £395 | £427 | |
| Paragraph 5(1) | £867 | £936 | |
| Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | ||
| In column 2 of the Table in paragraph 1 | |||
| Entry 1 | £12,209 | £13,186 | |
| Entry 2(a) | £5,027 | £5,429 | |
| Entry 2(b)(i) | £1,257 | £1,358 | |
| Entry 2(b)(ii) | £628 | £678 | |
| Entry 2(b)(iii) | £204 | £220 | |
| Entry 2(c)(i) | £550 | £594 | |
| Entry 2(c)(ii) | £275 | £297 | |
| Entry 2(c)(iii) | £102 | £110 | |
| Entry 2(d)(i) | £227 | £245 | |
| Entry 2(d)(ii) | £113 | £122 | |
| Entry 2(d)(iii) | £50 | £54 | |
| Entry 2(e) | £62 | £67 | |
| Paragraph 2(a) | £280 | £302 | |
| Paragraph 2(b) | £138 | £149 | |
| Paragraph 2(c) | £58 | £63 | |
| Paragraph 3(a) | £5,027 | £5,429 | |
| Paragraph 3(b) | £3,394 | £3,666 | |
| Paragraph 7 | £251 | £271 | |
| Paragraph 8(1) | £155 | £167 | |
| Paragraph 8(2) | £93 | £100 |
Signed
Signed by authority of the Secretary of State for Health
Hunt — Parliamentary Under Secretary of State, — Department of Health — 2002-03-06
Whitty — Parliamentary Under Secretary of State, — Department for Environment, Food and Rural Affairs — 2002-03-11
Bairbre de Brún — Minister of Health, Social Services and Public Safety — 2002-03-11
Bríd Rodgers — Minister of Agriculture and Rural Development — 2002-03-11
We consent,
Anne McGuire — Nick Ainger — Two of the Lords Commissioners of Her Majesty’s Treasury — 2002-03-06
Explanatory note
(This note is not part of the Regulations)
Footnotes
[^f00001]: 1972 c. 68.
[^f00002]: S.I. 1972/1811.
[^f00003]: 1973 c. 51.
[^f00004]: 1971 c. 69; as amended by section 21 of the Health and Medicines Act 1988 (c. 49). By virtue of section 1(3) of the 1971 Act, expressions used in that section have the same meaning as in the Medicines Act 1968 (c. 67), as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388 and by article 5 of, and the Schedule to, S.I. 1999/3142; see therefore section 1(1) of the 1968 Act, which contains a definition of “the Ministers’” which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144), by virtue of which the references in section 1(1) and (2)(b) of the 1971 Act to a licence under Part II of the 1968 Act include reference to a marketing authorization under the 1994 Regulations.
[^f00005]: In the case of the Secretary of State concerned with health in England, by virtue of articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; in the case of the Minister of Agriculture, Fisheries and Food, by virtue of articles 2(2) and 5 of, and the Schedule to, S.I. 1999/3142; in the case of the Minister of Health, Social Services and Public Safety and the Minister of Agriculture and Rural Development, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47).
[^f00006]: 1968 c. 67.
[^f00007]: S.I. 1995/449; amended by S.I.1998/574, 1999/566, 2000/592 and 2001/795.
[^f00008]: S.I. 1995/1116; amended by S.I. 1996/683, 1998/574, 1999/566, 2000/592 and 3031, and 2001/795.
[^f00009]: S.I. 1994/105; amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2000/592 and 2001/795.
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