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The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
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- UK Statutory Instruments
- 2006 No. 1928
- Regulation 9
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Amendment of regulation 15 of the principal Regulations
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9. In regulation 15 of the principal Regulations (ethics committee opinion), in paragraph (5)—
(a)in sub-paragraph (b), for “paragraph 2” substitute “paragraph 10”;
(b)in sub-paragraph (e), after “investigator’s brochure” insert “ or, where the investigational medicinal product has a marketing authorization and the product is to be used in accordance with the terms of that authorization, the summary of product characteristics relating to that product”; and
(c)in sub-paragraph (h)—
(i)after “include” insert “ minors or”, and
(ii)for “Part 5” substitute “Part 4 or Part 5 respectively”.
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