Marketing Authorization Holders (MAH) in Estonia involved in medicines/medicinal products and medical devices are expected to develop and implement a full pharmacovigilance approach for the Estonian market in accordance with the relevant EU legislation.
The MAH is expected to work closely with the Pharmacovigilance Centre (within the State Agency of Medicines (SAM)) 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.
National legislation allows for the qualified person responsible for pharmacovigilance activities (QPPV) in Estonia to be resident outside the country (although they must be resident within the EU). However, the MAH must appoint an Estonian-speaking contact person. This contact person will have specific responsibility for the provision of information to prescribers with regard to any safety risks associated with the use of medicines.
With a comprehensive understanding of local pharmacovigilance processes and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services in the Estonian market within a fully comprehensive outsourced local pharmacovigilance solution.
For those involved in medicines/medicinal products and medical devices, the pharmacovigilance service package comprises: