The following accompanying documentation can now be submitted directly via the portal along with applications for authorisation and variation for medicinal products with immediate effect.
- Electronic data sets relating to preclinical studies in SEND format (Standard of the Exchange of Nonclinical Data)
- Electronic data sets from pivotal bioequivalence studies
- Films regarding the safety, efficacy and quality of medicinal products (see guidance document Mobile technologies)
The data sets can be uploaded in the portal in addition to the eCTD and eDok dossiers. You can find details on how to do this in the Information sheet.