For those involved in medicines/medicinal products and medical devices in the Czech Republic developing and maintaining an approved approach to pharmacovigilance and medical device vigilance is vital. The area requires a comprehensive response from the marketing authorization holder (MAH), with the specific requirements clearly detailed within the Act on Pharmaceuticals.
With regards to pharmacovigilance, the response required by the MAH is significant and includes the need to maintain a range of different tracking documentation, meet all sample/data requests made by SUKL at all times, make publicly-available an information help service for its medicinal products and ensure that all local sales personnel are trained in terms of pharmacovigilance.
Understanding the complex local system for pharmacovigilance is vital. Establishing and maintaining an appropriate response is a given, but this can prove difficult without access to qualified, local personnel.
Any marketing authorization holder (MAH) in the Czech Republic is expected to appoint a QPPV, a qualified person responsible for pharmacovigilance who should be resident in the EU but whose details should be provided to SUKL. SUKL could further request that the MAH appoint a local pharmacovigilance contact person, who would then report to the QPPV.
The MAH must implement and regularly audit a pharmacovigilance system compatible with that required by the Czech authorities. If the QPPV does not speak Czech or Slovak, the local pharmacovigilance contact person reporting to the QPPV, must speak either the Czech or Slovak language. The MAH must implement and regularly audit a pharmacovigilance system compatible with that required by the Czech authorities and must report all suspected adverse incidents to SUKL within 15 days of receiving the information.
With a comprehensive understanding of local pharmacovigilance requirements and local pharmacovigilance contacts Grove provides a range of pharmacovigilance activities in the Czech Republic within a fully comprehensive outsourced pharmacovigilance services solution.
For those involved in pharmaceuticals/medicines/drugs/medicinal products and medical devices, the pharmacovigilance service package comprises: