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Harmonised technical guidance for non ectd
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Harmonised Technical Guidance for Non-eCTD …
esubmission.ema.europa.euThis Guidance Document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic format to the National Competent Authorities in the EEA (hereafter referred to as NCAs).
eCTD Guidance Document - Europa
esubmission.ema.europa.euThis guidance document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic Common Technical Document format (eCTD) to the National Competent Authorities