What's new

20.7.2021 Fimea has updated the instructions for notification of shortage

14.7.2021 Fimea, SMPA and DKMA join forces to improve the IT based cooperation on pharma-covigilance

1.6.2021 New decree on fees chargeable by the Finnish Medicines Agency entered into force on 1 June 2021

26.5.2021 The new EU regulation on medical devices comes into force on 26 May 2021

21.5.2021 Substantial modifications included in the national pilot of the EU Clinical Trial Regulation

20.5.2021 Medicines with a marketing authorisation and traditional herbal medicinal products with a registration must have a summary of product characteristics also in Swedish by 9 February 2022

31.3.2021 The ‘Reports of adverse reactions to COVID-19 vaccines’ website will be developed to make it clearer

24.3.2021 The pilot of the clinical trial evaluation process is progressing as planned

18.3.2021 The benefits of the AstraZeneca’s corona vaccine still outweigh the adverse reactions - very rare cases of blood clotting disorders require further review

12.3.2021 Coronavirus vaccination programme continues in Finland – Fimea and THL follow the situation