Marketing Authorization Holders (MAH) in Latvia involved in medicines and medical devices are expected to develop and implement a full pharmacovigilance approach in accordance with the relevant EU legislation.
The MAH is expected to work closely with the Latvian 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 activities 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) for the Latvian market. If the QPPV does not reside in the country, the MAH must appoint a local contact person for pharmacovigilance issues. Reporting to and acting in accordance with the instructions of the QPPV, the local contact person must live and work in Latvia and full contact details (including contact details for out-of-hours) must be provided to the Latvian State Agency of Medicines (SAM).
With a comprehensive understanding of local pharmacovigilance processes and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services in Latvia within a fully comprehensive outsourced local pharmacovigilance solution.
For those involved in pharmaceuticals and medical devices, the pharmacovigilance service package comprises: