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Pharmaceutical Product Safety Monitoring System

Patient safety has the highest priority for us and we have an established safety monitoring system in place to comply with current guidelines.

Pharmacovigilance (PV) is an obligation for marketing authorization holders (MAHs) of pharmaceutical products. In all aspects of pharmaceutical industry it is important to have the patient in focus and to ensure safe products for patients.

All MAHs in EU/EEA are obliged to have a PV system in place and to describe all activities within the PV system in a PV master file. The purpose of the PV system is to monitor the safety of authorized medicinal products and detect any change to the risk-benefit balance.

To report side effects/adverse events or safety concerns on Omacor® or Zodin®

Rapportering av bivirkninger på Omacor® eller Zodin®

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Take & Tell

Take & Tell is an initiative by Uppsala Monitoring Centre (UMC) to increase awareness of side effects & encourage safer medicines for all. More information on www.takeandtell.org.

Side effect music video from Uppsala Monitoring Centre (UMC):

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9 million patient/years in our Monitoring System Database
24-hours reporting system

Some important PV tasks and responsibilities:

  • Having a 24-hour available qualified person responsible for PV (QPPV)
  • Reporting of adverse events related to the products to the authorities
  • PV agreements with contractual partners describing the exchange of adverse event reports, reconciliation procedure etc.
  • Describing the PV system in a PV master file (PSMF)
  • Literature search; Signal detection analysis of the safety database
  • Periodic safety update report (PSUR); report providing an evaluation of the benefit-risk balance of a medicine; Pharmacovigilance audits of contractual partners
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All adverse events are coded as MedDRA terms, see more about MedDRA at http://www.meddra.org/