Legal Basis:

German Medicines Act (.pdf file)

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, as amended

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

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

Guidelines:

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

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

Guideline on good pharmacovigilance practices (GVP): Module IX Addendum I - Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

Data Lock Points:

List of European Union Reference Dates (EURD-List)

DLPs for substances for special therapies (herbals and homoeopathics) (.xlsx file)