For those involved in medicines/medicinal products and medical devices in the Hungarian market developing and maintaining an approved approach to pharmacovigilance is vital. The area is tightly controlled and based on EU legislation, with local interpretation.
The marketing authorization holder (MAH) is expected to meet strict criteria within the following areas:
- Adverse event reporting
- Direct healthcare professional communication
- Provision of additional risk minimization measures
- Submission of periodic safety update reports (PSURs)
- PV inspection (with inspections carried out at least every 3-5 years by OGYEI)
A risk management plan (RMP) must be produced and lodged with the appropriate authorities prior to the submission of any marketing authorization documentation. A pharmacovigilance system master file (PSMF) must be created and lodged along with the initial marketing authorization documentation.
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
Any marketing authorization holder (MAH) is expected to appoint a qualified person for pharmacovigilance (QPPV) in Hungary. If the QPPV lives in the country then they must hold a degree in medicine, pharmacy, dentistry or biology, demonstrate knowledge with regard to pharmacovigilance systems and be able to operate them and have at least three years of medical experience in pharmacovigilance.
If the QPPV is not a medical doctor, then the MAH must make ‘ensure the availability of a medical doctor’ and provide his/her details to the authorities.
If the QPPV does not live in Hungary, then the MAH must appoint a national contact person. This contact person must hold a degree in life science, chemistry or chemical engineering and must have been adequately trained on the reporting requirements to the EU-QPPV. This training must have been provided or acknowledged by the MAH.
With a comprehensive understanding of local pharmacovigilance processes and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services in Hungary within a fully comprehensive outsourced local pharmacovigilance services solution.
A FULLY COMPREHENSIVE SOLUTION FOR PHARMACOVIGILANCE SERVICES
Grove offers a fully comprehensive outsourced solution for local pharmacovigilance activities 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 Hungarian authorities. The service is continually developed to ensure it remains relevant and is bespoke to the client in question.
For those involved in pharmaceuticals/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 reporting
- In-time case 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 (Medical Literature Monitoring) services
- Pharmacovigilance training for the client’s local sales force
- System quality control checks to ensure full audit compliance
