Finland: updated guideline on reporting of adverse reactions to drugs and vaccines

31 January 2011

Ella Mikkola

The updated Pharmacovigilance Administrative Regulation 5/2010 (“Adminstrative Regulation”) of the Finnish Medicines Agency (Fimea) entered into force on 1 January 2011. By updating the Administrative Regulation, Fimea has implemented nationally the requirements of pharmacovigilance in compliance with the EU Regulation.

The Fimea Guideline on the Reporting of Adverse Drug Reactions (“ADR Guideline”) has also been updated and entered into force on 1 January 2011. Fimea maintains a national register of adverse reactions to drugs. Persons authorised to prescribe or supply drugs shall report to Fimea any adverse reaction they find or suspect in association with the medicines. It is recommended that such reports on adverse reactions be submitted in writing by using either the electronic form, or the PDF form, which are available on the website of Fimea (www.fimea.fi).

In Finland, the reporting of adverse reactions to vaccines was widely debated and discussed last autumn when Finland suspended H1N1 (“swine flu”) vaccines due to increased reports of narcolepsy in children and teens. The ADR Guideline also clarifies the reporting of adverse reactions to vaccines. The register of adverse reactions to vaccines is maintained by the National Institute for Health and Welfare (THL). Healthcare professionals shall report all diagnosed or suspected adverse reactions to vaccines that come to their knowledge.

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