For those involved in medicines/medicinal products and medical devices in the Croatian market developing and maintaining an approved approach to pharmacovigilance is vital. The Croatian authorities have a strong focus on pharmacovigilance and the MAH is expected to develop and manage appropriate structures accordingly.
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
Any marketing authorization holder (MAH) in Croatia is expected to appoint a local qualified person for pharmacovigilance (QPPV). This is in addition to the appointment of an appropriately qualified person responsible for pharmacovigilance in the European Union (EU-QPPV). Both of these individuals should be ‘permanently and continuously at the disposal of the MAH’.
Taking responsibility as the local contact person for HALMED for all pharmacovigilance issues, the local QPPV must be approved by HALMED. He/she must be resident in Croatia and cannot be appointed unless they meet specific requirements associated with PV-related education/qualifications for example, as stipulated in Croatian legislation. He/she will be responsible for establishing and implementing the MAH’s PV system in the country; he/she will be the contact point for HALMED and available 24/7; and will be the contact point for any PV inspection.
With a comprehensive understanding of local pharmacovigilance procedures and local pharmacovigilance contacts Grove provides a range of pharmacovigilance activities in Croatia within a fully comprehensive outsourced local pharmacovigilance solution.
A FULLY COMPREHENSIVE SOLUTION FOR PHARMACOVIGILANCE SERVICES
Grove offers a fully comprehensive outsourced solution for pharmacovigilance activities in the Croatian market for clients unable or unwilling to invest in the development of relevant systems on their own account.
With proven success over two decades, Grove has developed a comprehensive package which meets the needs of both its individual clients and the relevant local authorities. The service is continually developed to ensure it remains relevant and is bespoke to the client in question.
For those involved in medicines/drugs/medicinal products and medical devices, the pharmacovigilance service package comprises:
- Full-time (24/7) service of a local qualified pharmacovigilance person, QPPV
- 24-hour cover for adverse event case processing
- In-time advert event reporting
- End-to-end processing of safety information
- Production of PSUR (periodic safety update reports)
- Production of individual case study reports
- Access, as and when appropriate, to local healthcare professionals and authorities
- MLM, local Medical Literature Monitoring services
- System quality control checks to ensure full audit compliance