The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009

Made: 7th December 2009

Laid before Parliament: 10th December 2009

Coming into force: 1st January 2010

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PART 1 — GENERAL

Citation, commencement and interpretation

1

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PART 2 — AMENDMENTS TO THE FEES REGULATIONS 2009 IN RESPECT OF FEES FOR VARIATIONS

Amendments to the Fees Regulations 2009

2

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Amendment to regulation 18

3

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Insert of new regulation 18A

4

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Amendment to regulation 20

5

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Insert of new regulation 20A

6

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Amendments to Schedule 1

7

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Amendments to Schedule 7

8

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PART 3 — CONSEQUENTIAL AMENDMENTS

The Marketing Authorisations Regulations 1994

9

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PART 4 — SAVINGS

Savings

10

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Signed

Signed by authority of the Secretary of State for Health

Mike O'Brien — Minister of State, — 30th November 2009

Michael McGimpsey — Minister for Health, Social Services and Public Safety — 30th November 2009

Bob Blizzard — Frank Roy — Two of the Lords Commissioners of Her Majesty's Treasury — 7th December 2009

Explanatory note

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Footnotes

[^f00001]: 1971 c.69; relevant amendments were made by regulation 45(2) of S.I. 2008/2297 and section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the Medicines Act 1971, expressions used in that section as amended have the same meaning as in the Medicines Act 1968 (c.67) as amended. 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. 1993/3142, by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794 and by regulation 44 of, and Schedule 8 to, S.I. 2006/2407. Section 1(1) of the 1968 Act contains a definition of the expression “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 an application for a licence or for the variation or renewal of such a licence under Part II of the 1968 Act include reference to an application for a marketing authorization under the Regulations or for the variation or renewal of such an authorization.

[^f00002]: In the case of the Secretary of State by virtue of article 2(1) of S.I. 1999/3142. In the case of the Minister for Health, Social Services and Public Safety by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Department for which the Minister is responsible was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1).

[^f00003]: 1972 c.68; as amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.51).

[^f00004]: 1973 c.51.

[^f00005]: S.I. 1972/1811.

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

[^f00007]: S.I. 2009/389.

[^f00008]: S.I. 1994/3144; relevant amending instruments are S.I. 2003/2321, 2004/3224 and 2005/1094.

[^f00009]: See Article 1 of the Regulation.

[^f00010]: A copy of the guidance can be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at Market Towers, 1, Nine Elms Lane, London, SW8 5NQ or by sending an email to info@mhra.gsi.gov.uk.

[^f00011]: Copies of the documents can be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at Market Towers, 1, Nine Elms Lane, London, SW8 5NQ or by sending an email to .

[^f00012]: OJ No. L 334, 12.12.2008 p.7.

Editorial notes

[^key-dbf28f9ffa3749aa3ba13e527af853cc]: Regulations revoked (1.4.2013) by The Medicines (Products for Human Use) (Fees) Regulations 2013 (S.I. 2013/532), reg. 1(2), Sch. 9

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