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After Authorisation

In the navigation bar on the left you will find:

• National Variations, information about variations in particulars and documents in accordance with sections (§§) 22 – 24 AMG
• Variations, information about variations in particulars and documents in accordance with Variation Regulation (EC) 1234/2008
• Renewals, information about the renewal of marketing authorisation or registration of medicinal products in accordance with §§ 31, 39 AMG and Article 24 of Directive 2001/83/EC and Article 14 of EU Regulation No. 726/2004
• PUMA (Paediatric use marketing authorisation)
• Information on the publication of the results of clinical trials in accordance with Section 42b AMG