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eCTD Guidance Document - Europa
esubmission.ema.europa.euPage 1 of 60 . Guidance for Industry on Providing Regulatory Information in Electronic Format . Harmonised Technical Guidance for . eCTD Submissions in the EU
Module 1 - Administrative information application form
www.ema.europa.euHarmonised Technical Guidance (see above). Which language should be used in the application form? English should be used for a centralised procedure. English should be used for a mutual recognition or decentralised procedure.
Harmonised Technical Guidance for Non-eCTD electronic ...
esubmission.ema.europa.euTechnical NeeS Guidance v4.0 Page 1 of 19. Guidance for Industry on Providing Regulatory Information in Electronic Format . Harmonised Technical Guidance for . Non-eCTD electronic Submissions (NeeS) for human medicinal products in the EU . Version 4.0 October 2013