Marketing Authorization Holders (MAH) involved in medicines/medicinal products and medical devices are expected to develop and implement a full pharmacovigilance and medical device vigilance approach for Lithuania in accordance with the relevant EU legislation.
The MAH is expected to work closely with the State Medicines Control Agency (SMCA) to manage the data generated from pharmacovigilance activities. Regular reporting and transfer of information is required.
Collaboration is evident between the regulatory agencies in the Baltic States, and agreement has been reached, for example, with regard to GMP, GDP and pharmacovigilance inspections. Further change in the administrative processes associated with local pharmacovigilance is likely as a result. This should be to the benefit of those working in one or (more particularly) more than one of the Baltic States. Monitoring and planning for change is vital.
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
Any marketing authorization holder (MAH) is expected to appoint a qualified person for pharmacovigilance (QPPV) to oversee pharmacovigilance activities in Lithuania.
As stated in the Law on Pharmacy, the State Medicines Control Agency (SMCA) can request the nomination of a local contact person for pharmacovigilance in the country.
With a comprehensive understanding of local pharmacovigilance requirements and local pharmacovigilance contacts Grove provides a range of pharmacovigilance activities in Lithuania within a fully comprehensive outsourced local pharmacovigilance services solution.
A FULLY COMPREHENSIVE SOLUTION FOR LOCAL PHARMACOVIGILANCE SERVICES
Grove offers a fully comprehensive outsourced solution for local pharmacovigilance services in the Lithuanian 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 national authorities. The service is continually developed to ensure it remains relevant and is bespoke to the client in question.
For those involved in pharmaceuticals 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, local Medical Literature Monitoring services
- Pharmacovigilance training for the client’s local sales force
- System quality control checks to ensure full audit compliance
