Pharmacovigilance services in Latvia

The State Agency of Medicines (SAM) monitors pharmacovigilance and related activities in Latvia. From receipt and processing of ADR reports to finally submission in the European database to evaluation of signals, periodic safety update reports (PSURs), risk management plans (RMPs) and pharmacovigilance inspections, SAM oversees all important pharmacovigilance operations. Marketing authorization holders (MAHs) should report ICSRs of Latvia directly to the EudraVigilance Human Post Authorisation Module (EVPM) with the message receiver identifier EVHUMAN. MAHs must also appoint a responsible QPPV who lives and works within the European Union that would be responsible for the development and maintenance of a pharmacovigilance system. If the QPPV does not reside in Latvia, then MAHs should appoint a national level contact person for pharmacovigilance issues. The authority shall exchange information regarding pharmacovigilance issues (also on the adverse drug reactions) with the State Agency of Medicines and marketing authorisation holders in order to ensure effective functioning of the pharmacovigilance system.

As a leading global contender, DDReg understands the significance of patient safety right from spontaneous to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Latvia that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.