For those involved in medicines and medical devices in Montenegro developing and maintaining an approved approach to pharmacovigilance and medical device vigilance is vital. The area continues to evolve in terms of the response required from the marketing authorization holder (MAH).
The Law on Medicines states that healthcare professionals must report all suspected adverse reactions to the national Agency for Medicines and Medical Devices (CALIMS). Adverse reactions can be reported to CALIMS directly, or through the MAH in Montenegro. Adverse reactions are monitored by CALIMS and the Institute for Public Health. There is evidence that many adverse events go unreported, and CALIMS is working to address this through increasing dialogue with healthcare professionals.
In most cases, CALIMS will take responsibility for DHPC. Where the MAH is to engage in DHPC, the content of any communication and the associated plan for communication with the healthcare professional(s) involved must be previously approved by CALIMS.
The MAH is required to set up and maintain a comprehensive pharmacovigilance system in Montenegro. It must be managed by a local qualified person for pharmacovigilance (QPPV).
CALIMS has the power to change the conditions under which the MAH operates or, in the worst-case scenario, to revoke the marketing authorization, if it deems this necessary based on pharmacovigilance inspection/activities.
With a comprehensive understanding of local pharmacovigilance requirements and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services within a fully comprehensive outsourced local pharmacovigilance solution.
For those involved in pharmaceuticals and medical devices, the pharmacovigilance service package comprises: