Auf dieser Seite finden Sie wichtige Dokumente rund um das Thema PSUR-Erstellung zum Download (.pdf):

Gesetzliche Grundlagen:

Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz – AMG) (.pdf-Datei)

Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (.pdf-Datei)

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, as amended (.pdf-Datei)

Regulation (EC) No 726/2004 Of The European Parliament And Of The Council of 30 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended (.pdf-Datei)

Richtlinien:

Guideline on good Pharmacovigilance Practices (GVP) - Module VII - Periodic safety update report (.pdf-Datei)

Guideline on good Pharmacovigilance Practices (GVP) - Module IX - Signal Management (.pdf-Datei)

Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation (.pdf-Datei)

Data Lock Points:

List of European Union Reference Dates (EURD-List)

DLPs für Substanzen der besonderen Therapierichtung (.xlsx-Datei)