Pharmacovigilance

MONITORING OF MEDICINAL PRODUCTS SAFETY

The monitoring of medicinal products safety during their period of use, known as pharmacovigilance, includes all activities that are related to detection, assessment, understanding, and prevention of adverse drug reactions and other possible medicinal product-related problems. Monitoring and assessment of the benefits and risks of the medicinal product is important to ensure that the balance between the benefit and the risk remains positive for the patients taking the medicine. 
 
Activities in the field of pharmacovigilance include:

  • collecting and assessing reports on adverse drug reactions and assessments of the ratio between the benefits and the risks of medicinal products
  • assessment of other data related to medicinal products safety (studies, information published in scientific literature, etc.)
  • detecting safety signals, assessment of identified risks, and adopting and implementing measures for the safe use of medicinal products
  • assessment of safety data submitted by marketing authorisation holder in the Periodic Safety Update Reports (PSUR)
  • assessment of Risk management plans, including risk minimisation measures
  • activities in the international pharmacovigilance system, including reporting to EudraVigilance, the European database of adverse drug reactions and to VigiBase, the database of the World Health Organization, within the WHO Programme for International Drug monitoring
  • conducting of pharmacovigilance inspections of marketing authorisation holders
  • encouraging healthcare professionals and patients to report adverse drug reactions
  • informing healthcare professionals and the public about pharmacovigilance of medicinal products

The field of pharmacovigilance is managed by:

  • Medicinal Products Act (Official Gazette of the Republic of Slovenia, No. 17/14)
    Rules on pharmacovigilance of medicinal products for use in human medicine (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 57/14 and 27/17)
  • 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
  • Commission delegated regulation (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required
  • GVP - Good pharmacovigilance practices

For more information regarding adverse reactions to medicinal products, the importance of collecting and assessing reports on adverse drug reactions, and on the means of reporting, see

Reporting suspected adverse drug reactions  

PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE (PRAC)

In July 2012, the Pharmacovigilance Risk Assessment Committee (PRAC) began operating at the European Medicines Agency, which replaced the Pharmacovigilance Working Party (PhVWP). This body is responsible for monitoring and assessing safety issues related to medicinal products licenced to be marketed in the European Union. This includes the detection, assessment, minimisation and communication of the risks of adverse drug reactions while taking the therapeutic effect of the medicinal product into account. It is also responsible for design and evaluation of post-authorisation studies and for pharmacovigilance inspections. Its main task is to provide recommendations regarding any questions on pharmacovigilance of medicinal products for human use and on risk management systems, including the monitoring of their effectiveness.

More information about the work of PRAC, agendas and minutes of the meetings are available at the European Medicines Agency website.