Pharmacovigilance – information for marketing authorisation holders

Pharmacovigilance is a key public health activity to safeguard and maximise the safety of medicines. Its mission is to continuously monitor the benefit-risk balance of medicines throughout their complete life cycle in order to identify and assess any changes in the benefit-risk balance, and to set out measures, when necessary, to prevent or minimise risks and maximise the benefits of medicine use.

Another goal of pharmacovigilance is proactive risk management, during which potential, unknown or unclarified risks of medicines are identified and further investigated via well-designed and thorough information gathering in order to identify measures for the prevention or timely management of such risks.

Please refer to the menu on the left for information on the obligations of marketing authorisation holders in Hungary concerning pharmacovigilance. Please note that information published should always be interpreted and used together with the operative pharmacovigilance legislation of the EU and Hungary and relevant official guidance documents.

Legal background

· Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 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

· Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending as regards pharmacovigilance of medicinal products of human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products

· Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance

· 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

· Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use

· Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance

· Decree 15/2012 (VIII. 22.) of the Ministry of Human Resources on the Pharmacovigilance of Medicinal Products for Human Use

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

· Guidelines on good pharmacovigilance practices (GVP)

 

Last updated: 2018.01.29 10:30