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The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
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- 1994 No. 3144
- SCHEDULE 1
- Regulation 7
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7. A person required to maintain the records mentioned in paragraph 6 shall—
(a)notify the licensing authority of any suspected adverse reaction such as is mentioned in head (e) of that paragraph which is a serious adverse reaction; and
(b)make available for inspection at all reasonable times by the licensing authority the records mentioned in that paragraph.
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