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Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to Marketing Authorisation Holders

In accordance with the European Parliament and Council Regulation (EC) No 726/2004 and the Directive 2001/83/EC the amendments regarding the pharmacovigilance have been made in the Medicinal Products Act in Estonia. The purpose of the amendments is to strengthen pharmacovigilance system. The amendments in the Medicinal Products Act entering into force on 21st of July 2012.

Marketing Authorisation Holders (MAH) shall report ICSRs reported by healthcare professionals and non-healthcare professionals in Estonia directly to the EudraVigilance database. All serious ICSRs should be reported electronically within 15 days and non-serious ICSRs within 90 days.

Reporting requirements applicable to Marketing Authorisation Holders during the transitional period

- Serious ICSRs that occur in Estonia

Marketing Authorisation Holders should report all serious suspected adverse reactions for a medicinal product authorised via Centalised, Mutual recognition, Decentalised or National procedure within 15 days directly to the European Medicines Agency via EudraVigilance database (through Gateway or Webtrader). 

- Non-serious ICSRs that occur in Estonia

During the transitional period there is no requirements for reporting non-serious ICSRs that occur in Estonia.

- ICSRs that occur outside the European Union for a medicinal product authorised in Estonia

All serious ICSRs in the territory of non-EU country for medicinal products authorised in Estonia should be reported directly to the EMA via EudraVigilance database, and no later than 15 days following receipt of the information.

Requirements related to SUSARs from interventional clinical trials (Directive 2001/20/EC) are not affected by this instruction.

Last updated: 28.02.2024