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VOLUME 2B Module 1.2: Administrative information ...

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Health systems, medicinal products and innovation Revision 15 NOTICE TO APPLICANTS Medicinal Products for Human Use VOLUME 2B Module : Administrative information Application form September 2021 This application form will be included in: The Rules governing Medicinal Products in the European Union The Notice to Applicants - VOLUME 2B - Common Technical Document- Module 1- Administrative information To be noted: As from 01/01/2016, mandatory use of electronic application forms for all procedures .

A DECENTRALISED PROCEDURE (according to Article 28(3) of Directive 2001/83/EC ) Reference Member State: Procedure number: Concerned Member State(s) (specify): AT BE BG CY CZ DE DK EE EL ES FI FR HR HU IE IS IT LI LT …

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