Citation and commencement

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

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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

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