Pharmacovigilance and vigilance of medical devices

Pharmacovigilance services include:

  • a local pharmacovigilance contact with 24-hour availability,
  • collecting and reporting suspected adverse events and other safety information,
  • maintaining the pharmacovigilance system,
  • preparing and maintaining standard operating procedures (SOPs),
  • communication with the competent authority and our partners,
  • reviewing nationally prescribed literature,
  • monitoring of local legislation and HA website,
  • preparation of applications for review of educational material (under the RMP) and preparation of DHPCs.

As part of our medical device vigilance services, we provide:

  • local contact with 24-hour standby,
  • communication with the competent authority (reporting to the competent authority about incidents with medical devices)
  • informing customers in case of field safety notices and incidents with medical devices.

Your contact

Reporting of suspected adverse events
+386 31 685 085

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