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.
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.
For those involved in pharmaceuticals and medical devices, the pharmacovigilance service package comprises: