eCTD submission

New version of the Guideline on eSubmissions for Veterinary Products

The new version of the Guideline on eSubmissions for Veterinary Products – version 2.4 together with eSubmission Validation checklist – version 2.4 and tools is published.The new VNeeS Guideline, checklist and checker will come into force on 01/07/2016.

This guidance covers all types of initial applications for marketing authorisation made in the Centralised (CP), Mutual Recognition (MRP), Decentralised (DCP) and National procedures including updates provided during the assessment phase (validation updates and responses to questions).


http://esubmission.ema.europa.eu/tiges/docs/E-submission-GL- Ver 2.4 15 Dec 2015-clean.pdf

Author

KnetAdmin

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