Pharmacovigilance

Pharmavigil_About-us_logo_eng

  • We offer the services of local pharmacovigilance person for Croatia, CZ Republic, Slovenia, Bulgaria, Serbia, Montenegro, Hungary, Slovakia.

  • We prepare high -quality Risk management plans (RMP) and Periodical Safety Update Reports (PSURs).

  • We establish the PV systems for wholesalers and other companies.

  • We educate company personnel in pharmacovigilance.

  • We organize approval, preparation and distribution of educational materials for HCPs.

  • We offer services of validation, implementation and maintenance of safety databases.

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Our working hours or the quality of our services did not change due to the COVID-19 pandemics

Tools for e-submission

Tools for e-submission

Since 1st of January 2017, an e-CTD became an obligatory format and method of submission and e-CTD software became indispensable tool for each MAH in the EU. Also, many non-EU health and regulatory authorities follow this path closely [e.g. Health Canada]. Therefore we have decided to expand our range of services. (more…)

Mobile application for reporting adverse drug reactions for medicinal products

Mobile application for reporting adverse drug reactions for medicinal products

Suspected ADR can be, as of now, reported via mobile application of Croatian Medicinal Products and Medical Devices Agency (HALMED), intended to the patients, health care professionals, caregivers and other citizens. (more…)