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Backbone Files Spec Module 1
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EU Module 1 eCTD Specification - Europa
esubmission.ema.europa.eudifferent Member States. However, at the same time the EU Module 1 Specification allows for country-specific information to be included in Module 1, if required. Country-specific information could relate to the details of the business process applied (e.g. specifying the number and names of …