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.
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"
Commission Implementation Regulation (EU) No 520/2012 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
Additional risk minimisation measures (aRMM) - Submission of educational materials (updated 05.08.2020)
Changes in reporting adverse drug reactions to Eudravigilance (updated 08.12.2017)
Last updated: 14.07.2021