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Pharmacovigilance
The Serbian Agency for Medicinal Products and Medical Devices carries out the activities of organized and continual monitoring of undesirable effects of medicinal products by applying the standards of Good Practice in Pharmacovigilance:- spontaneous reporting on adverse effects of medicinal products,
- collecting and evaluating reports by health-care workers on adverse effects during medical treatments of patients,
- reporting on adverse effects during clinical trials and
- evaluating periodical reporting on adverse effects of medicinal products in post-marketing period, submitted in accordance with regulations by responsible persons for pharmackovigilance of medicinal products manufacturers (Periodic Safety Update Reports - PSURs).
Volume 9 of the EU regulations concerning pharmacovigilance of medicinal products in humane as well as in veterinary medicine, guidelines from the International Conference on Harmonization (ICH) are utterly implemented within the Agency. The National Centre is also continually cooperating through vigibase with Collaboration Centre of the World Health Organization for the monitoring of adverse reactions to medicinal products in Upsala. The experts from the center regularly attend informative and educational meetings in this domain, as well as annual meetings of the Member States of the International Center in Upsala and others.
The estimation of medicinal product safety profile is a good precondition for carrying out rational (efficient, safe and economical) pharmacotherapy.
The implementation of modern clinical pharmacology principle, clinical pharmacy, pharmacotherapy pharmacokinetics, pharmacotherapy and pharmacoepidemiology is imperative in reaching rational application of medicinal products.
The National Pharmacovigilance Center contributes to applied pharmacotherapy to achieve the desirable therapeutic effect with minimal risk of the adverse reactions to the medicinal products, by keeping records of and evaluating all reported adverse reactions to medicinal products, assessment of cause-consequence relationship between the application of a medicinal product/medical device and the adverse reactions, identification of potential signals, determining factors of risk, estimation of incidence, as well as elaboration of other significant periodical analysis of the reported adverse reactions.
Information for the web-site users
Collaboration Centre of the World Health Organization for the monitoring of adverse reactions to medicinal products presented on its web-site our national pharmacovigilance system for the period January 2005 - January 2007, which can bee seen on the web-site http://www.who-umc.org following the steps:
On the web-site http://www.who-umc.orgyou can find useful information from the field of pharmacovigilance and functioning of WHO-UMC.