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Guideline on the Regulation of Therapeutic Products in New ...
Guideline on Strategies to Identify and Mitigate Risks for First-In-Human Clinical Trials with Investigational Medicinal Products (EMEA/ CHMP/SWP/28367/07 Rev.1) ... Guideline on the Regulation of Therapeutic Products in New Zealand provides additional guidance. The terms ‘unapproved medicine’ and ‘lapsed approval’ are synonymous with ...
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