A list of relevant national and international regulations and guidelines pertaining to PSUR submission and writing has been provided below.

German Medicines Act (Arzneimittelgesetz-AMG_Kons.); Version 2012

6. Bekanntmachung zur Anzeige von Nebenwirkungen und Arzneimittelmissbrauch nach § 63b Absatz 1 bis 9 des Arzneimittelgesetzes (AMG); Version 2010

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use; Version 2012

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004; Version 2010

Commission Implementing Regulation (EU) No 520/2012; Version June 2012

Guideline on good pharmacovigilance practices (GVP) - Module VII – Periodic safety update report; Version 2012

VOLUME 9A of The Rules Governing Medicinal Products in the European Union– Guidelines on Pharmacovigilance for Medicinal Products for Human Use; Version 2008

Please note:

To open PDF-files and to activate links contained in them, you must use the PDF-Reader! This program will allow you to open, print, and search PDF-files.