State Agency of Medicines is working in close cooperation with WHO Collaborating Centre for International Drug Monitoring Centre in Uppsala. Since 1998 Estonia is a full member of WHO Drug Monitoring Programm as member country.
The programme for collection of spontaneous adverse drug reaction reports is functioning since 1993.
The activities of the pharmacovigilance centre cover the whole country. Reporting of adverse drug reactions in Estonia is voluntary for healthcare professionals.
For reporting of ADRs occurring within Estonia the reporting form is available ("yellow card") which is distributed with Drug Information Bulletin, by mail to doctors and with data sheet compendium Pharmaca Estica.
Useful links
Minister of Social Affairs Regulation No. 26 “Procedure for providing safety information about a medicinal product and the calculation of fee payable for safety and quality surveillance of a medicinal product"
Guidance: Additional Risk Minimisation Measures – submission of materials (updated 26.01.2023)
Guidance: Direct Healthcare Professional Communication - DHPC (updated 26.01.2023)
Changes in reporting adverse drug reactions to Eudravigilance (updated 08.12.2017)
Submission of safety variations following signal and PSUR assessment outcome
Last updated: 02.05.2023