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    Pharmacovigilance and Adverse Drug Reactions (ADR)

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    Pharmacovigilance activities (collection, collation and evaluation of adverse drug reactions occurring within Estonia and reported by healthcare professionals) are carried out by the Pharmacovigilance Centre which is functioning under State Agency of Medicines.

    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

    The electronic reporting form is available at Agencys homepage

    Information to Marketing Authorisation Holders and Sponsors of Clinical Trials - Eudravigilance for Human Medicines

    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"