11/8/2023 0 Comments Pharmaceutical dossier definition![]() ![]() Nonclinical trials data and data from its clinical use, if any, should be included.Summaries of information or data related to the quality, manufacture, and control of the IMP should be included in an IMPD.Example of the label in the national language.Ethical assessment by principal investigator ′ Investigators Brochure′.Summary of the protocol in the national language.Arrangement for recruitment of subjects. ![]()
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