Practical guidelines relating to non-eCTD electronic submissions - Scientific guideline

The use of the electronic common technical document (eCTD) format for electronic-only submissions in the centralised procedure is mandatory since 1 January 2010. This non-eCTD electronic submission guideline applied until 1 January 2010 and was intended as a transitory measure to improve the standardisation and quality of all non-eCTD electronic submissions provided in the context of the centralised procedure before the deadline.

 

Current effective version

EMEA implementation of electronic-only submission and eCTD submission: Practical guidelines relating to non-eCTD electronic submissions

AdoptedReference Number: EMEA/633919/2008 v1.0