The Medicines for Human Use (Fees Amendments)(No. 2) Regulations 2005

Made: 26th October 2005

Laid before Parliament: 26th October 2005

Coming into force

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Citation, commencement and interpretation

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Amendment of regulation 2 of the General Fees Regulations

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Amendment of regulation 3A of the General Fees Regulations

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Amendment of Part II of the General Fees Regulations

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Amendment of regulation 6C of the General Fees Regulations

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Amendment of Part III of the General Fees Regulations

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Amendment of regulation 12 of the General Fees Regulations

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Amendment of regulation 12A of the General Fees Regulations

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Amendment of Part V of the General Fees Regulations

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Amendment of Part VI of the General Fees Regulations

10

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Amendment of regulation 19 of the General Fees Regulations

11

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Amendment of Part I of Schedule 1 to the General Fees Regulations

12

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Amendment of Part II of Schedule 1 to the General Fees Regulations

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Amendment of Part III of Schedule 1 to the General Fees Regulations

14

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Amendment of Part IIIA of Schedule 1 to the General Fees Regulations

15

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Amendment of Schedule 2 to the General Fees Regulations

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Amendment of Schedule 3 to the General Fees Regulations

17

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Amendment of Schedule 4 to the General Fees Regulations

18

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Amendment of Schedule 5 to the General Fees Regulations

19

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Amendment of Schedule 6 to the General Fees Regulations

20

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Signed

Signed by authority of the Secretary of State for Health

Jane Kennedy — Minister of State, — Department of Health — 24th October 2005

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

D Kenny — A senior Officer, — Department of Health, Social Services and Public Safety — 24th October 2005

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

Pat Toal — Permanent Secretary, — Department of Agriculture and Rural Development — 26th October 2005

We consent,

Tom Watson — Joan Ryan — Two of the Lords Commissioners of Her Majesty’s Treasury — 24th October 2005

Explanatory note

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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); 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.

[^f00005]: 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).

[^f00006]: 1968 c. 67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.

[^f00007]: 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.

[^f00008]: The definition of “change of ownership application” was substituted by regulation 2 of S.I. 1996/683 and amended by regulation 2(2)(b) of S.I. 2004/1157.

[^f00009]: OJ No. L214, 24.08.93, p.1.

[^f00010]: The definition of “the 2001 Directive” was inserted by regulation 16(a)(ii) of S.I. 2002/236 and amended by regulation 8(2)(a) of S.I. 2003/2321.

[^f00011]: OJ No. L33, 8.2.2003, p.30.

[^f00012]: OJ No. L159, 27.6.2003, p.46.

[^f00013]: OJ No. L136, 30.4.2004, p.85.

[^f00014]: OJ No. L136, 30.4.2004, p.34.

[^f00015]: The definition of “EEA State” was inserted by regulation 2(1)(a) of S.I. 2001/795.

[^f00016]: S.I. 2005/2750.

[^f00017]: OJ No. L136, 30.4.2004, p.1.

[^f00018]: Regulation 3A was inserted by regulation 4(3) of S.I. 2003/625 and amended by regulation 5(2) of S.I. 2004/666.

[^f00019]: Regulation 4 was amended by S.I. 2004/666 and 2004/1157.

[^f00020]: Regulation 5 was amended by S.I. 2004/666 and 2004/1157.

[^f00021]: Regulation 6C was inserted by regulation 3 of S.I. 2000/3031 and renumbered by regulation 5(2) of S.I. 2001/795.

[^f00022]: Paragraph (3) was inserted by regulation 8(b) of S.I. 2004/666.

[^f00023]: Paragraph (1) was renumbered as such by regulation 4(4) of S.I. 2004/1157.

[^f00024]: Regulation 12A was inserted by regulation 5(3) of S.I. 2002/542.

[^f00025]: Regulation 13A was inserted by regulation 6(3) of S.I. 2004/1157.

[^f00026]: Regulation 14A was inserted by regulation 7(1) of S.I. 2004/1157.

[^f00027]: The definition of “EC marketing authorization” was inserted by regulation 9(2)(a) of S.I. 2004/1157.

[^f00028]: The definition of “Phase IV trial” was inserted by regulation 9(2)(b) of S.I. 2004/1157.

[^f00029]: Paragraph 7 was substituted by regulation 9(1)(3)(b) of S.I. 2004/1157.

[^f00030]: The definition of “Extended Type II Complex Variation Application” was inserted by regulation 11(2)(a) of S.I. 2003/2321.

[^f00031]: The definition of “reclassification variation application” was inserted by regulation 5(6)(a)(i) of S.I. 2002/542.

[^f00032]: Paragraph 11 was substituted by regulation 9(4)(c) of S.I. 2004/1157.

[^f00033]: Part IIIA was inserted by regulation 5(7) of S.I. 2002/542.

[^f00034]: Paragraph 5A was inserted by regulation 4(7)(f) of S.I. 2003/625.

[^f00035]: Paragraph 10 was inserted by regulation 11(b) of S.I. 2004/1157.

[^f00036]: Paragraph 4A was inserted by regulation 6 of S.I. 2000/2031 and amended by regulation 5(11) of S.I. 2001/795 and regulation 16(k) of S.I. 2002/236.

[^f00037]: Paragraph 2B was inserted by regulation 5(8) of S.I. 2002/542.

[^f00038]: Paragraph 2C was inserted by regulation 5 of S.I. 2005/1124.

[^f00039]: Paragraph 4A was inserted by regulation 7(4) of S.I. 2004/1157.

[^f00040]: Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ No. L136, 30.4.2004, p.85.

[^f00041]: Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community code relating to medicinal products for human use, OJ L311, 28.11.2001, p 67.

[^f00042]: Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ No. L136, 30.4.2004, p.34.

[^f00043]: Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ No. L136, 30.4.2004, p.1.

[^f00044]: OJ No. L214, 24.08.93, p.1.

[^f00045]: Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ No. L159, 27.6.2003, p.46.

[^f00046]: S.I. 2005/1094.

Editorial notes