Search results with tag "Eu module 1"
Version 1.4.1 November 2011 - Europa
esubmission.ema.europa.euThis document describes only the region-specific information that is common to all submissions in the different Member States. However, at the same time the EU Module 1 Specification allows for
eCTD Guidance Document - Europa
esubmission.ema.europa.euThe structure and organisation of an eCTD submission is defined by the following standards: • ICH M2 eCTD Specification • EU Module 1 Specification • Relevant ICH and EU Q&A docs . Annex 1 contains links to the currently approved version of these documents.
EU Module 1 eCTD Specification - Europa
esubmission.ema.europa.euEU Module 1: Regional Information The ICH Common Technical Document (“CTD”) specifies that Module 1 should contain regionspec- ific administrative and product information. The content and numbering of Module 1 for the EU is specified in the latest version of …
EU Module 1 eCTD Specification - Europa
esubmission.ema.europa.eu4 Reviewers Version Name Organisation 0.1-0.3 EU Regulators EU Regulatory Authorities, EMEA 0.4 Interested parties 0.5-0.6 EU Regulators EU Regulatory Authorities, EMEA