New variations regulation: Regulatory and procedural guidance
Updated formatted table template for dossier submission available | European Medicines Agency
From 1 January , the electronic Common Technical Document eCTD is the only acceptable electronic format for all applications and all submission types in the context of the centralised procedure. These include new applications, supplementary information, variations , renewals , follow up measures FUMs , periodic safety update reports PSURs for centralised authorised products, Notifications etc. There is no obligation to submit a full, reformatted eCTD for already authorised products. However, if marketing authorisation holders wish, they may provide EMA with information reformatted as eCTD for their already authorised products. In particular, EMA would encourage the submission of reformatted quality information in eCTD, in order to facilitate the handling of variations and line extensions.
Medicines: apply for a variation to your marketing authorisation
Human eSubmission eCTD v3. Industry access. Paediatric submissions.