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

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


The Finnish Medicines Agency (Fimea), the Swedish Medical Products Agency (SMPA) and the Danish Medicines Agency (DKMA) have joined resources and established a new long-term collaboration in the area of pharmacovigilance and information technology. The overall purpose is to optimize the use of the common resources when it comes to operate a common pharmacovigilance system. An endeavour that in the end should benefit patient safety for all three countries.

The three agencies have done so in order to fulfil their respective obligations under regulations (EU) 520/2012 and (EU) 2019/6 as National Competent Agencies. This collaboration takes the form a consortium agreement with the purpose to join forces in the development and subsequent use of a joint Nordic pharmacovigilance system. This system will replace aging national solutions for each country and is designed to optimize handling of adverse effects and foster new and fruitful collaboration between the agencies in the area of pharmacovigilance.

Fimea, SMPA and DKMA have jointly set a number of objectives to be achieved over the lifespan of the consortium. These objectives include:

  • To improve customer service, efficiency, and quality of result in the fulfilment of pharmacovigilance accountability.
  • To leverage our Nordic colleagues’ expertise and knowledge better, to drive faster and more productive business improvements.
  • To lower costs and achieve increased value for the investments in procuring Pharmacovigilance IT-solutions.
  • To achieve improved quality, accuracy and speed of signal detection and case management.

Ask more

  • Eija Pelkonen, Director General, +358 29 522 3100
  • Auli Aalto, IT Project Manager + 35829 522 3622
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