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The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
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- UK Statutory Instruments
- 1994 No. 3144
- SCHEDULE 2
- Paragraph 10
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Person appointed to hear representations
10. Any notification given under paragraph 9—
(a)in a case falling within sub-paragraph (a), (b) or (c) of that paragraph, shall state the advice of the Medicines Commission or of the appropriate committee and the reasons stated by the Medicines Commission or the committee for giving that advice;
(b)in a case falling within sub-paragraph (d) of that paragraph (whether it also falls within any of the other sub-paragraphs of that paragraph or not), shall include a statement of the proposals of the licensing authority and of the reasons for them.
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