The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Eudralex Volume 2A Procedures for Marketing Authorisation Chapter 1 - Marketing Authorisation (updated version November 2018)

Origin/Publisher:

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Document Type:
Notice to Applicants
Content:
This document provides the general principles of pharmaceutical legislation concerning marketing authorisation of medicinal products in the EU.

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