IMP Dossier

About Investigational Medicinal Product Dossiers. Substantial Modifications and Amendments. About Investigational Medicinal Product Dossiers. What is an IMPD? Guidance and legal basis. The guidance is based on Regulation EU No 5362014 on Clinical Trials on Medicinal Products for Human Use Repealing Directive 200120EC on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials.

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IMP Dossier

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About Investigational Medicinal Product Dossiers. Substantial Modifications and Amendments. About Investigational Medicinal Product Dossiers. What is an IMPD? Guidance and legal basis. The guidance is based on Regulation EU No 5362014 on Clinical Trials on Medicinal Products for Human Use Repealing Directive 200120EC on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials.

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This site states the following, "About Investigational Medicinal Product Dossiers." We observed that the web page stated " What is an IMPD? Guidance and legal basis." It also stated " The guidance is based on Regulation EU No 5362014 on Clinical Trials on Medicinal Products for Human Use Repealing Directive 200120EC on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials."

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