EU Module 1 eCTD Specification - Europa
Submission Unit Type The submission unit type element of the envelope metadata set describes the content at a lower level (a “sub-activity”) which is submitted in relation to a defined regulatory activity such as the initial submission, the applicant response to validation issues or list of questions or any other additional information.
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EU Module 1 eCTD Specification - Europa
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Guideline on the specifications for provision of an ...
esubmission.ema.europa.euGuideline on specification for veterinary e-submissions Page 1 of 19 ... Version 2.45 December 20165 . Guideline on the specifications for provision of an electronic submission (e-submission) for a veterinary medicinal product. Adoption by Veterinary Harmonisation Group (version 2.45) December 20165 ... application form may accompany or follow ...
Annex 4 to the HMA eSubmission Roadmap: Replacement of …
esubmission.ema.europa.eucommon repositories and use of master data (SPOR). CESSP Phase 1 is the first project towards the implementation of the Common European Single ... Implementation roadmap The replacement will apply to all the application forms and will be deployed in a stepwise approach,