Approval & Lifecycle Management: Electronic Submission
AGES PharmMed now accepts purely electronic submissions for human medicinal products without additional paper submission, except for those documents that need to be signed: company letter and application form.
AGES PharmMed strongly recommends that electronic submissions comply with the eCTD or NeeS standard. In this context it is pointed out that the eCTD is the preferred standard and the NeeS standard is only an interim solution.
Electronic submission is currently not yet mandatory at AGES PharmMed; paper submission will continue to be accepted.
Further information:
Submissions in the medicinal product procedure
Further inquiries:
DI Dr. Christa Wirthumer-Hoche
Head of Institute Regulatory Affairs & Lifecycle Management
E-mail: c hrista.wirthumer-hoche@ages.at
