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.
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
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.
A FULLY COMPREHENSIVE SOLUTION FOR LOCAL PHARMACOVIGILANCE SERVICES
Grove offers a fully comprehensive outsourced solution for local pharmacovigilance services in the Latvian 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 local 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 case processing
- 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