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