The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009

Made: 6th May 2009

Laid before Parliament: 7th May 2009

Coming into force: 8th May 2009

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 . He is designated for the purposes of that section in relation to medicinal products .

Citation and commencement

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 5 to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of regulation 30 of the Medicines for Human Use (Clinical Trials) Regulations 2004

3

For paragraph 2 of regulation 30 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (urgent safety measures) , substitute the following paragraphs—

(2) If measures are taken pursuant to paragraph (1), the sponsor shall— (a) where paragraph (3) applies, as soon as possible; and (b) in any other case, immediately, and in any event no later than 3 days from the date the measures are taken, give written notice to the licensing authority and the relevant ethics committee of the measures taken and the circumstances giving rise to those measures. (3) This paragraph applies for any period during which a disease— (a) is pandemic; and (b) is a serious risk to human health or potentially a serious risk to human health.

Amendment of regulation 8 of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Signed

Signed by authority of the Secretary of State for Health.

Dawn Primarolo — Minister of State, — 2009-05-06

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 1972 c.68; section 2(2) was amended by the Legislative and Regulatory Reform Act 2006 (c.51), section 27(1)(a).

[^f00003]: S.I. 1994/3144; Schedule 5 was amended by S.I. 1998/3105, S.I. 2000/292, S.I. 2002/236, S.I. 2002/542 and S.I. 2003/1618.

[^f00004]: S.I. 2004/1031.

Editorial notes

[^c19685671]: 1972 c.68; section 2(2) was amended by the Legislative and Regulatory Reform Act 2006 (c.51), section 27(1)(a).

[^c19685701]: S.I. 2004/1031.

[^key-fc93ddde2bfab7676f59a337d2bac93a]: Regs. 1, 2 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

[^key-892dd37c64de9e692371ec1eb4075c11]: Reg. 4 revoked (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)