Submission of complete identical document sets for eDOK and eCTD has been clarified with regard to co-marketing medicinal products.
In addition, the submission deadline for variations without assessment after implementation for VMPs has been extended from a maximum of 1 month to a maximum of 60 calendar days.
Other editorial changes have also been made as part of the update to the guidance document.
The revised guidance document Formal requirements is valid with effect from 1 October 2023.