EMA-raadpleging: ontwerprichtlijn inzake behandeling en verzending van geneesmiddelen voor onderzoek menselijk gebruik
The European Medicines Agency has released for public consultation a 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.
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.
The draft guideline is available by clicking here.
Comments should be provided using this template and sent to firstname.lastname@example.org by 31 August 2018.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).