Agency for Medicinal Products and Medical Devices (HALMED)
This sponsor has funded 2 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 11628 | Planned | Implementation of new pharmacovigilance legislation concerning the new adverse drug reactions definition (IMAGINATION) | No | No |
| 11644 | Planned | Preventable Adverse Drug Reactions reported to the Croatian Agency for Medicinal Products and Medical Devices (PREVENTABLE) | No | No |
PAS by Risk Management Plan (RMP) requirement
Agency for Medicinal Products and Medical Devices (HALMED)
The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.
Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.
PAS by study status
Agency for Medicinal Products and Medical Devices (HALMED)
The study status is defined according to the timeline dates specified.
Planned studies have not collected any data yet.
Ongoing studies collect data and should publish protocols as soon as possible.
Finalised studies should publish results in the first two weeks after finalisation.
Countries
Agency for Medicinal Products and Medical Devices (HALMED)
1 Study countries specified are the following:
- Croatia