For those involved in medicines and medical devices in the Serbian market developing and maintaining an approved approach to pharmacovigilance is required. The area continues to evolve in terms of the complexity of response required from the marketing authorization holder (MAH).
The pharmacovigilance activities of marketing authorization holders in Serbia are overseen by the Medicines and Medical Devices Agency (ALIMS). The MAH is expected to provide a detailed description of the pharmacovigilance system proposed to the National Pharmacovigilance Centre (NPC) within ALIMS. Any changes proposed to the SOP must be reported. All adverse reactions must be reported to the NPC. Healthcare institutions, healthcare professionals, marketing authorization holders and clinical trial sponsors are all required to report all adverse events. Patients may also report adverse events if they choose to. The Ministry of Health will conduct routine and ad-hoc pharmacovigilance inspections as they deem necessary.
Any marketing authorization holder (MAH) in Serbia is expected to appoint a local qualified person for pharmacovigilance (QPPV).
Pharmacovigilance is a key area of focus for the national regulatory authorities. This is an area which will continue to develop in terms of both responsibility and investment for marketing authorization holders.
With a comprehensive understanding of local pharmacovigilance requirements and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services in Serbia within a fully comprehensive outsourced local pharmacovigilance solution.
For those involved in medicines and medical devices, the pharmacovigilance service package comprises: