For those involved in medicines/medicinal products and medical devices in Bulgaria developing and maintaining an approved approach to pharmacovigilance and medical device vigilance is vital. As an EU-member state, Bulgaria adheres to EU pharmacovigilance requirements, but meeting these needs given the complexities associated with the local healthcare sector structures/systems can prove challenging.
That said, the Bulgarian talent pool is such that at least one pharmaceutical company has been encouraged to centralize their European pharmacovigilance activities in Bulgaria.
The MAH must implement and regularly audit a pharmacovigilance system for Bulgaria. All serious adverse events identified in Bulgaria must be reported electronically to the EMA within 15 days as is the case in other EU member states. Similarly, non-serious adverse events identified in Bulgaria should be reported electronically to the EMA within 90 days.
Any marketing authorization holder (MAH) in Bulgaria must nominate a local contact in Bulgaria to work with a local QPPV (qualified person responsible for pharmacovigilance) responsible for pharmacovigilance in Bulgaria. Details of the local contact must be submitted to the Bulgarian Drug Agency.
With a comprehensive understanding of local pharmacovigilance requirements in Bulgaria Grove provides a range of pharmacovigilance services in Bulgaria within a fully comprehensive outsourced local pharmacovigilance services solution in Bulgaria.
For those involved in pharmaceuticals/medicines/drugs and medical devices, the pharmacovigilance service package comprises: