- Statutory Instrument 2006 No. 494
The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006
© Crown Copyright 2006
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| Made | 27th February 2006 | ||
| Laid before Parliament | 3rd March 2006 | ||
| Coming into force | 1st April 2006 |
The Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971[1] or, as the case may be, the powers conferred by those provisions and now vested in them[2].
In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972[3] and section 56(1) and (2) of the Finance Act 1973[4]. The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products[5].
The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.
In accordance with section 129(6) of the Medicines Act 1968[6], the Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.
Citation, commencement and interpretation
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[7];
-
"the General Fees Regulations" means the Medicines (Products for Human Use—Fees) Regulations 1995[8]; and
-
"the Homoeopathic Products Regulations" means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994[9].
Amendment of the General Fees Regulations
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) [10], 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) [11], 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) [12], 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[13], 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.".
Amendment of the Homoeopathic Products Regulations
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[14]—
-
(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".
Amendment of regulation 3 of the Devices Regulations
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
| Column (1) | Column (2) | Column (3) | Column (4) |
| Provision in the General Fees Regulations | Subject Matter | Old Amount | New Amount |
| Regulation 3B[15] | Capital fees for pre-application meetings | ||
| Paragraph (a) | £1,012 | £1,118 | |
| Paragraph (b) | £1,346 | £1,486 | |
| Paragraph (c) | £1,690 | £1,866 | |
| Paragraph (d) | £2,024 | £2,235 | |
| Regulation 3BA[16] | Capital fees for advertising advice meetings | £1,346 | £1,486 |
| Regulation 3BB[17] | Capital fees for pharmacovigilance advice meeting | ||
| Paragraph (a) | £1,690 | £1,866 | |
| Paragraph (b) | £1,346 | £1,486 | |
| Regulation 3BC[18] | Capital fees for advice meetings concerning labelling and leaflets | £1,012 | £1,118 |
| Regulation 3BD[19] | Capital fees for post authorisation regulatory advice meetings | £1,346 | £1,486 |
| Regulation 6 | Applications for certificates by exporters of medicinal products | ||
| Paragraph (1)(a) | £118 | £130 | |
| Paragraph (1)(b) | £53 | £58 | |
| Paragraph (1)(c)(i) | £53 | £58 | |
| Paragraph (1)(c)(ii) | £26 | £29 | |
| Regulation 11 | Renewal of certain manufacturer's licences | £127 | £152 |
| Part II of Schedule 1 | Capital fees for applications for authorizations, licences and certificates | ||
| In Column 2 of the Table in paragraph 1[20] | |||
| Entry 1(a) | £25,802 | £28,494 | |
| Entry 1(b) | £56,218 | £61,959 | |
| Entry 1(c) | £56,218 | £61,959 | |
| Entry 1(d) | £80,698 | £88,993 | |
| Entry 1(e) | £115,098 | £126,982 | |
| Entry 1(f) | £80,698 | £88,993 | |
| Entry 2(a) | £15,689 | £17,202 | |
| Entry 2(b) | £15,689 | £17,202 | |
| Entry 2(c) | £22,366 | £24,576 | |
| Entry 2(d) | £31,219 | £34,353 | |
| Entry 2(e) | £22,366 | £24,576 | |
| Entry 3(a) | £5,820 | £6,304 | |
| Entry 3(b) | £5,820 | £6,304 | |
| Entry 3(c) | £8,272 | £9,011 | |
| Entry 3(d) | £11,813 | £12,921 | |
| Entry 3(e) | £8,272 | £9,011 | |
| Entry 4(a) | £2,337 | £2,457 | |
| Entry 4(b) | £2,337 | £2,457 | |
| Entry 5 | £1,493 | £1,638 | |
| Entry 6 | £366 | £404 | |
| Paragraph 1A(1) | £6,558 | £7,824 | |
| Paragraph 4(4)(b) | £500 | £594 | |
| Paragraph 5(1)(a) | £142 | £156 | |
| Paragraph 5(1)(b) | £268 | £295 | |
| Paragraph 5(1)(c) | £2,444 | £2,688 | |
| Paragraph 6(1) | £1,402 | £1,542 | |
| Paragraph 6(2) | £600 | £660 | |
| Paragraph 6(4) | £310 | £341 | |
| In Column 2 of the Table in paragraph 7[21] | |||
| Entry 1 | £610 | £674 | |
| Entry 2 | £2,700 | £2,982 | |
| Entry 3 | £2,250 | £2,485 | |
| Entry 4 | £140 | £155 | |
| Part IIA of Schedule 1[22] | Capital fees for assistance in obtaining marketing authorizations in other EEA States | ||
| Paragraph 2(a)(i) | £34,400 | £37,989 | |
| Paragraph 2(a)(ii) | £22,596 | £24,953 | |
| Paragraph 2(b)(i) | £8,853 | £9,777 | |
| Paragraph 2(b)(ii) | £5,902 | £6,518 | |
| Paragraph 2(c)(i) | £3,541 | £3,910 | |
| Paragraph 2(c)(ii) | £2,951 | £3,259 | |
| Paragraph 2(d) | £2,119 | £2,340 | |
| Part III of Schedule 1 | Capital fees for applications for variations of authorizations, licences and certificates | ||
| Paragraph 2(a) | £142 | £170 | |
| Paragraph 2(aa) | £224 | £266 | |
| Paragraph 2(b) | £590 | £704 | |
| Paragraph 2(c) | £6,672 | £7,964 | |
| Paragraph 2(cc) | £22,254 | £24,576 | |
| Paragraph 2(d) | £6,558 | £7,824 | |
| Paragraph 3(a) | £222 | £264 | |
| Paragraph 3(aa) | £442 | £526 | |
| Paragraph 3(b) | £714 | £852 | |
| Paragraph 3(c) | £11,568 | £13,808 | |
| Paragraph 3(d) | £31,106 | £34,353 | |
| Paragraph 5A(1) | £500 | £594 | |
| Paragraph 6(a) | £142 | £158 | |
| Paragraph 6(b) | £6,558 | £7,824 | |
| Paragraph 6(c) | £296 | £326 | |
| Paragraph 7(a) | £200 | £220 | |
| Paragraph 7(b) | £400 | £440 | |
| Paragraph 8 | £200 | £220 | |
| Paragraph 9 | £378 | £416 | |
| Paragraph 10 | £200 | £220 | |
| Paragraph 11(1)(a) | £100 | £110 | |
| Paragraph 11(1)(b) | £200 | £220 | |
| Paragraph 11(1)(c) | £300 | £330 | |
| Paragraph 15(a)(ii) | £500 | £594 | |
| Paragraph 15(a)(iii) | £250 | £297 | |
| Paragraph 15(b)(ii) | £250 | £297 | |
| Part IIIA of Schedule 1[23] | Capital fees for assessment of labels and leaflets | ||
| Paragraph 2(a) | £430 | £472 | |
| Paragraph 2(b) | £273 | £300 | |
| Part IV of Schedule 1[24] | Capital fees for regulatory assistance given by the United Kingdom acting as reference Member State relating to the assessment of applications for the renewal of specified marketing authorizations | ||
| Paragraph 1(a) | £7,415 | £8,847 | |
| Paragraph 1(b) | £605 | £722 | |
| Paragraph 2(a)(ii) | £605 | £722 | |
| Paragraph 2(b)(ii) | £303 | £361 | |
| Schedule 2 | Fees for inspections | ||
| Paragraph 2(a)(i) | £2,534 | £3,618 | |
| Paragraph 2(a)(ii) | £4,654 | £6,645 | |
| Paragraph 2(a)(iii) | £5,610 | £8,010 | |
| Paragraph 2(a)(iv) | £9,578 | £13,676 | |
| Paragraph 2(b)(i) | £2,751 | £3,928 | |
| Paragraph 2(b)(ii) | £5,610 | £8010 | |
| Paragraph 2(b)(iii) | £8,782 | £12,539 | |
| Paragraph 2(b)(iv) | £15,926 | £22,740 | |
| Paragraph 2(c)(i) | £1,005 | £1,563 | |
| Paragraph 2(c)(ii) | £2,717 | £3,879 | |
| Paragraph 2(c)(iii) | £4,035 | £5,761 | |
| Paragraph 2(c)(iv) | £7,512 | £10,726 | |
| Paragraph 2(cc)(i) | £1,518 | £2,243 | |
| Paragraph 2(cc)(ii) | £4,048 | £5,856 | |
| Paragraph 2(cc)(iii) | £7,590 | £10,914 | |
| Paragraph 2(d) | £221 | £240 | |
| In column 2 in the Table in paragraph 2(f)[25] | |||
| Entry for "none" | £1,023 | £1,461 | |
| Entry for "1 to 4" | £1,226 | £1,751 | |
| Entry for "5 to 20" | £2,035 | £2,906 | |
| Entry for "21 to 100" | £4,059 | £5,796 | |
| Entry for "101 to 500" | £9,119 | £9,484 | |
| Entry for "more than 500" | £16,203 | £16,850 | |
| Paragraph 4A(1)(b) | £3,000 | £4,284 | |
| Paragraph 4A(1)(c) | £4,000 | £5,712 | |
| Paragraph 5(1) | £499 | £712 | |
| Paragraph 5(1) | £1,095 | £1,563 | |
| In column 2 in the Table in paragraph 5(3)[26] | |||
| Entry for "none" | £1,023 | £1,461 | |
| Entry for "1 to 4" | £1,226 | £1,751 | |
| Entry for "5 to 20" | £2,035 | £2,906 | |
| Entry for "21 to 100" | £4,059 | £5,796 | |
| Entry for "101 to 500" | £9,119 | £9,484 | |
| Entry for "more than 500" | £16,203 | £16,850 | |
| Paragraph 5A(a)[27] | £3,542 | £5,057 | |
| Paragraph 5A(b) | £5,060 | £7,225 | |
| Paragraph 5A(c) | £10,120 | £14,450 | |
| Paragraph 5D(1)(a)[28] | £600 | £800 | |
| Paragraph 5D(1)(b) | £1,100 | £1,300 | |
| Paragraph 5D(1)(c) | £1,100 | £1,300 | |
| Paragraph 7(4)(a)[29] | £3,000 | £4,284 | |
| Paragraph 7(4)(b) | £5,000 | £7,139 | |
| Paragraph 7(4)(c) | £10,000 | £14,279 | |
| Paragraph 7(4)(d) | £15,000 | £21,418 | |
| Paragraph 7(4) | £3,000 | £4,284 | |
| Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | ||
| In column 2 of the Table in paragraph 1 | |||
| Entry 1 | £14,768 | £17,278 | |
| Entry 2(a) | £6,080 | £7,114 | |
| Entry 2(b)(i) | £1,521 | £1,780 | |
| Entry 2(b)(ii) | £759 | £888 | |
| Entry 2(b)(iii) | £247 | £289 | |
| Entry 2(c)(i) | £666 | £779 | |
| Entry 2(c)(ii) | £333 | £390 | |
| Entry 2(c)(iii) | £123 | £144 | |
| Entry 2(d)(i) | £275 | £322 | |
| Entry 2(d)(ii) | £137 | £160 | |
| Entry 2(d)(iii) | £60 | £70 | |
| Entry 2(e) | £75 | £88 | |
| Paragraph 2(a) | £338 | £395 | |
| Paragraph 2(b) | £167 | £195 | |
| Paragraph 2(c) | £71 | £83 | |
| Paragraph 3(a) | £6,080 | £7,114 | |
| Paragraph 3(b) | £4,105 | £4,803 | |
| Paragraph 7(2) | £304 | £356 | |
| Paragraph 8(1) | £187 | £219 | |
| Paragraph 8(2) | £112 | £131 | |
| Paragraph 10[30] | £200 | £234 |
(This note is not part of the Regulations)
These Regulations make further amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 ("the Homoeopathic Products Regulations"), the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 ("the Devices Regulations") and the Medicines (Products for Human Use—Fees) Regulations 1995 ("the General Fees Regulations").
The General Fees Regulations make provision for the fees payable under the Medicines Act 1971, and other fees payable in respect of Community obligations, relating to marketing authorizations, licences and certificates in respect of medicinal products for human use. Regulation 2 and the Schedule to these Regulations provide for a number of the fees payable by virtue of the General Fees Regulations to be increased. The increases are of amounts between 4% and 42.8% , Most capital fees have been increased by amounts between 10% and 19% , periodic fees have been increased by 17% and all but two of the inspection fees have been increased by 42.8% (the remaining two inspection fees have both been increased by 4% ).
Regulation 2 also provides for certain provisions of the General Fees Regulations to be revoked. Those provisions provided for particular fees to be payable in respect of manufacturer's licences where those licences related solely to import of medicines from third countries. The revocation of those provisions means that the fees payable in respect of such licences will be the same as for other manufacturers' licences (i.e for manufacturer's licences which do not relate solely to import of medicines from third countries).
The Homoeopathic Products Regulations implemented in part Council Directive 92/73/EEC[31] (now replaced by Directive 2001/83/EC[32]) by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. Regulation 3 of these Regulations amends the Homoeopathic Products Regulations so as to increase the amounts of the fees payable for applications for, and variations of, certificates of registration and the fees payable by holders of certificates of registration. The increases average overall 10% .
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[33] concerning medical devices. Regulation 4 of these Regulations amends the Devices Regulations by increasing the amounts of the fees specified in regulation 3 of those Regulations. The increases average overall 10% .
A full Regulatory Impact Assessment of the effect that this instrument will have on the costs of business has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ
Notes:
[1] 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); see therefore section 1(1) of the 1968 Act, as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, by article 5 of, and the Schedule to, S.I. 1999/3142, and by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794, 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.back
[2] In the case of the Secretary of State, by virtue of article 2(1) of, and paragraph 1 of the Schedule to, S.I. 1999/3142 and article 3(1)(c) and (7) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794; and in the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, by virtue of the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47), which may now be exercised by the Departments by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c.1); the Departments were renamed by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I. 1).back
[6] 1968 c.67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.back
[7] S.I. 1995/449 relevant amending instrument is S.I. 2004/666.back
[8] 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.back
[9] 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.back
[10] Sub-paragraphs (1)(aa) and (3) were inserted by S.I. 2005/2979.back
[11] 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.back
[12] Sub-paragraph (e) was inserted by S.I. 2005/2979.back
[13] Paragraph 7 was substituted by S.I. 2005/2979.back
[14] As amended by S.I.1996/482 and S.I. 2005/2753.back
[15] Regulation 3B was inserted by S.I. 2003/625 and amended by S.I. 2003/2321 and 2004/666.back
[16] Regulation 3BA was inserted by S.I. 2004/666.back
[17] Regulation 3BB was inserted by S.I. 2004/666.back
[18] Regulation 3BC was inserted By S.I. 2004/666.back
[19] Regulation 3BD was inserted by S.I. 2004/666.back
[20] The Table was substituted by S.I. 2005/2979.back
[21] Paragraph 7 was substituted by S.I. 2004/1157 and amended by S.I. 2005/1124.back
[22] Part IIA was inserted by S.I. 2000/3031 and amended by S.I. 2001/795, 2002/236 and 242, 2003/625 and 2004/666.back
[23] Part IIIA was inserted by S.I. 2003/625 and amended by S.I. 2004/666, 2005/1124 and 2979.back
[24] Part IV was inserted by S.I. 2002/542.back
[25] Paragraph 2(f) was inserted by S.I. 2005/2979.back
[26] Paragraph 5(3) was inserted by S.I.2003/625.back
[27] Paragraph 5A was inserted by S.I. 2003/625.back
[28] Paragraph 5D was inserted by S.I. 2005/2979.back
[29] Paragraph 7 was inserted by S.I. 2004/1157.back
[30] Paragraph 10 was inserted by S.I. 2004/1157.back
[31] OJ No. L 297, 13.10.1992, p.8.back
[32] OJ No. L311, 28.11.2001, p.67;See articles 1(5), 13 to 16, 53, 68, 69, 85, 100, 119 and 124, Directive 2001/83/EC was amended by Council Directive 2004/27/EC (OJ No L136, 30.4. 2004, p.34)..back
[33] OJ No. L 169, 12.7.1993, p.1; amended by Directive 98/79/EC (OJ No. L 331, 7.12.1998, p.1).back
ISBN 0 11 074114 5