Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice

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Document details

Download document Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice
Reference number EMA/202679/2018
Status draft: consultation open
First published 2018-05-23
Last updated 2018-05-23
Consultation start date 2018-05-23
Consultation end date 2018-08-31
Email address for submissions adm-gmdp@ema.europa.eu

Summary

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.