LegalizeThe Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001
Made: 8th March 2001
Laid before Parliament: 9th March 2001
Coming into force: 1st April 2001
The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972[^f00001] in relation to medicinal products[^f00002], 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[^f00003], 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[^f00004], or, as the case may be, powers conferred by those provisions and now vested in them[^f00005], 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[^f00006], 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 2001 and shall come into force on 1st April 2001.
- (2) In these Regulations—
- “the Devices Regulations” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995[^f00007];
- “the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995[^f00008];
- “the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994[^f00009];
- “the Marketing Authorisations Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994[^f00010].
Amendment of the Marketing Authorisations Regulations
2
- (1) In regulation 1(2) of the Marketing Authorisations Regulations (interpretation)—
- (a) after the definition of “Community marketing authorisation” there shall be inserted the following definition—
- “EEA State” means a contracting party to the Agreement on the European Economic Area signed at Oporto on 2nd May 1992[^f00011] as adjusted by the Protocol signed at Brussels on 17th March 1993[^f00012];
- (b) after the definition of “the EMEA” there shall be inserted the following definition—
- “parallel import licence” means a United Kingdom marketing authorisation granted by the licensing authority under these Regulations in respect of a relevant medicinal product which is imported into the United Kingdom from another EEA state in accordance with the rules of Community law relating to parallel imports
- (c) the definition of “parallel import” shall be omitted; and
- (d) for the definition of “United Kingdom marketing authorisation” there shall be substituted the following definition—
- “United Kingdom marketing authorisation” means a marketing authorisation granted by the licensing authority under these Regulations and includes a parallel import licence.
- (2) In regulation 4(1) of the Marketing Authorisations Regulations (applications for the grant, renewal or variation of a United Kingdom marketing authorisation), for the words “any provision of Community law affecting” there shall be substituted the words “the rules of Community law relating to”.
- (3) In regulation 5 of the Marketing Authorisations Regulations (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorisation)—
- (a) in paragraph (1), after the word “provisions” at each place where it occurs, there shall be inserted the words “and (where applicable) the rules of Community law relating to parallel imports”;
- (b) in paragraph (2), after the words “every authorisation” there shall be inserted the words “, other than a parallel import licence,”; and
- (c) in paragraph (4), after the words “the 1965 Directive” there shall be inserted the words “or in relation to a parallel import licence”.
Amendment of the Homoeopathic Products Regulations
3
- (1) In regulation 1(2) of the Homoeopathic Products Regulations[^f00013] (interpretation), in the definition of “standard variation”—
- (a) at the end of paragraph (n) the word “or” shall be omitted;
- (b) at the end of paragraph (o) there shall be inserted the word “or”; and
- (c) after paragraph (o) there shall be inserted the following paragraph—
(p) a change following modification to the manufacturing authorisation.
- (2) In regulation 14[^f00014] of the Homoeopathic Products Regulations (fees for variations of certificates)—
- (a) in paragraph (1)(a), for “£90” there shall be substituted “£95”;
- (b) in paragraph (1)(b)(i), for “£90” there shall be substituted “£95”;
- (c) in paragraph (2)(a), for “£176” there shall be substituted “£185”;
- (d) in paragraph (2)(b)(i), for “£176” there shall be substituted “£185”; and
- (e) in paragraph (2)(b)(ii), for “£176” there shall be substituted “£185”.
- (3) In regulation 15(1)[^f00015] of the Homoeopathic Products Regulations (fees payable by holders of certificates), for “£11” there shall be substituted “£12”.
- (4) In the Table in Schedule 2 to the Homoeopathic Products Regulations[^f00016] (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 “£108” there shall be substituted “£113”,
- (ii) for “£325” there shall be substituted “£341”, and
- (iii) for “£535” there shall be substituted “£562”; and
- (b) in column (3) (fees for other applications)—
- (i) for “£267” there shall be substituted “£280”,
- (ii) for “£478” there shall be substituted “£502”, and
- (iii) for “£701” there shall be substituted “£736”.
Amendment of regulation 3 of the Devices Regulations
4
In regulation 3 of the Devices Regulations[^f00017] (fees)—
- (a) in paragraph (1)(a), for “£2,885” there shall be substituted “£3,029”;
- (b) in paragraph (1)(b), for “£6,406” there shall be substituted “£6,726”;
- (c) in paragraph (2)(a), for “£570” there shall be substituted “£599”;
- (d) in paragraph (2)(b), for “£1,596” there shall be substituted “£1,676”;
- (e) in paragraph (5)(a), for “£29,326” there shall be substituted “£30,972”; and
- (f) in paragraph (5)(b), for “£7,324” there shall be substituted “£7,690”.
Amendment of the General Fees Regulations
5
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SCHEDULE
| Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
| Provision in the General Regulations | Subject matter | Old amount | New amount |
| Regulation 6 | Applications for certificates by exporters of medicinal products | ||
| Paragraph (1)(a) | £96 | £100 | |
| Paragraph (1)(b) | £34 | £44 | |
| Paragraph (1)(c)(i) | £34 | £44 | |
| Paragraph (1)(c)(ii) | £17 | £22 | |
| Regulation 10 | Renewals of clinical trial certificates | £1,795 | £1,885 |
| Regulation 11(1) | Renewals of certain manufacturer’s licences | £102 | £107 |
| Part II of Schedule 1 | Capital fees for applications for authorisations, licences and certificates | ||
| In column 2 of the Table in paragraph 1(1) | |||
| Entry 1(a) | £21,545 | £22,622 | |
| Entry 1(b) | £46,085 | £48,389 | |
| Entry 1(c) | £65,835 | £69,127 | |
| Entry 2(a) | £12,568 | £13,196 | |
| Entry 2(b) | £17,955 | £18,853 | |
| Entry 3(a) | £4,605 | £4,835 | |
| Entry 3(b) | £6,584 | £6,913 | |
| Entry 4 | £1,795 | £1,885 | |
| Entry 5 | £1,196 | £1,256 | |
| Entry 6 | £296 | £310 | |
| Paragraph 5(1)(a) | £114 | £120 | |
| Paragraph 5(1)(b) | £216 | £227 | |
| Paragraph 5(1)(c) | £1,972 | £2,070 | |
| Paragraph 6(1) | £775 | £814 | |
| Paragraph 6(2) | £570 | £598 | |
| Paragraph 6(4) | £250 | £262 | |
| Paragraph 7 | £13,885 | £14,579 | |
| Part III of Schedule 1 | Capital fees for applications for variations of authorisations, licences and certificates | ||
| Paragraph 2(a) | £176 | £184 | |
| Paragraph 2(b) | £404 | £424 | |
| Paragraph 2(c) | £5,984 | £6,282 | |
| Paragraph 3(a) | £274 | £288 | |
| Paragraph 3(b) | £490 | £514 | |
| Paragraph 3(c) | £9,336 | £9,802 | |
| Paragraph 6(a) | £114 | £120 | |
| Paragraph 6(b) | £239 | £251 | |
| Paragraph 7(a) | £108 | £113 | |
| Paragraph 7(b) | £216 | £227 | |
| Paragraph 8 | £108 | £113 | |
| Paragraph 9 | £250 | £262 | |
| Paragraph 10 | £108 | £113 | |
| Paragraph 11 | £176 | £185 | |
| Paragraph 12 | £90 | £95 | |
| Schedule 2 | Fees for inspections | ||
| Paragraph 2(a)(i) | £1,870 | £1,964 | |
| Paragraph 2(a)(ii) | £3,470 | £3,643 | |
| Paragraph 2(a)(iii) | £4,190 | £4,400 | |
| Paragraph 2(a)(iv) | £7,182 | £7,541 | |
| Paragraph 2(b)(i) | £2,034 | £2,136 | |
| Paragraph 2(b)(ii) | £4,190 | £4,400 | |
| Paragraph 2(b)(iii) | £6,582 | £6,911 | |
| Paragraph 2(b)(iv) | £11,970 | £12,568 | |
| Paragraph 2(c)(i) | £718 | £754 | |
| Paragraph 2(c)(ii) | £2,010 | £2,110 | |
| Paragraph 2(c)(iii) | £3,003 | £3,153 | |
| Paragraph 2(c)(iv) | £5,625 | £5,906 | |
| Paragraph 2(d) | £136 | £143 | |
| Paragraph 5(1) | £376 | £395 | |
| Paragraph 5(1) | £826 | £867 | |
| Part III of Schedule 3 | Periodic fees for marketing authorisations and licences | ||
| In column 2 of the Table in paragraph 1 | |||
| Entry 2(a) | £4,788 | £5,027 | |
| Entry 2(b)(i) | £1,197 | £1,257 | |
| Entry 2(b)(ii) | £598 | £628 | |
| Entry 2(b)(iii) | £194 | £204 | |
| Entry 2(c)(i) | £524 | £550 | |
| Entry 2(c)(ii) | £262 | £275 | |
| Entry 2(c)(iii) | £97 | £102 | |
| Entry 2(d)(i) | £216 | £227 | |
| Entry 2(d)(ii) | £108 | £113 | |
| Entry 2(d)(iii) | £48 | £50 | |
| Entry 2(e) | £59 | £62 | |
| Paragraph 2(a) | £268 | £280 | |
| Paragraph 2(b) | £131 | £138 | |
| Paragraph 2(c) | £55 | £58 | |
| Paragraph 3(a) | £4,788 | £5,027 | |
| Paragraph 3(b) | £3,232 | £3,394 | |
| Paragraph 7 | £239 | £251 | |
| Paragraph 8(1) | £148 | £155 | |
| Paragraph 8(2) | £89 | £93 |
Signed
Signed by authority of the Secretary of State for Health
Hunt — Parliamentary Under Secretary of State, — Department of Health — 2001-03-05
Hayman — Minister of State, Ministry of Agriculture, Fisheries and Food — 2001-03-06
Bairbre de Brún — Minister of Health, Social Services and Public Safety — 2001-03-07
Bríd Rodgers — Minister of Agriculture and Rural Development — 2001-03-07
We consent,
Greg Pope — Jim Dowd — Two of the Lords Commissioners of Her Majesty’s Treasury — 2001-03-08
Explanatory note
(This note is not part of the Regulations)
These Regulations make further amendments to the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the Devices Regulations”), the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”), the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations”) and the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994 (“the Marketing Authorisations Regulations”).
The Marketing Authorisations Regulations implemented in part the following provisions of the European Community: Council Directives 65/65/EEC[^f00027], 75/318/EEC[^f00028], 75/319/EEC[^f00029] and any Regulation adopted by the Commission under Article 15 of that Directive, 89/342/EEC[^f00030], 89/343/EEC[^f00031], 89/381/EEC[^f00032], 92/26/EEC[^f00033], 92/27/EEC[^f00034], 92/73/EEC[^f00035], Regulation (EEC) No. 2309/93[^f00036] and any Regulations adopted by the Commission under Article 15.4 or 22.1 of that Regulation. They provide for the manner of making applications for the grant, renewal or variation of a United Kingdom marketing authorisation and for procedures for consideration, revocation, suspension and related matters. Regulation 2 of these Regulations amends the Marketing Authorisations Regulations by inserting into regulation 1(2) of those Regulations a definition of “EEA State”, omitting the definition of “parallel import”, inserting a definition of “parallel import licence” and substituting a new definition of “United Kingdom marketing authorisation”. Regulations 2(2) and (3) make amendments consequential on those new definitions. These amendments together with the amendments to the Fees Regulations referred to below clarify the status of the parallel import scheme.
The Homoeopathic Products Regulations implemented in part Council Directive 92/73/EEC[^f00037] by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. These Regulations amend the Homoeopathic Products Regulations in the following way. Regulation 3(1) of these Regulations adds to the definition of “standard variation”, regulation 3(2) increases the amounts of the fees payable for variations of certificates of registration, regulation 3(3) increases the fee payable by holders of certificates of registration and regulation 3(4) increases the amounts of the capital fees payable for applications for certificates of registration. These increases average overall 5%.
The Devices Regulations prescribe the fees which are payable where a notified body consults the competent body in accordance with Council Directive 93/42/EEC[^f00038] concerning medical devices. Regulation 4 of these Regulations amends the Devices Regulations by increasing the amounts of certain of the fees specified in regulation 3 of those Regulations by an average overall of 5%.
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