Pharmacovigilance services in Latvia

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Latvia, explore DDReg’s pharmacovigilance services in Latvia to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to signal detection, risk management planning, safety reporting, and successful market authorization, having a reliable pharmacovigilance consulting firm in Latvia or a Pharmacovigilance Services Provider in Latvia ensures your operations align with local and EU requirements.

The State Agency of Medicines (SAM) is the national authority responsible for pharmacovigilance in Latvia. It monitors all related activities such as the receipt and processing of individual case safety reports (ICSRs), submission to the European database (EudraVigilance), evaluation of signals, risk management plans (RMPs), periodic safety update reports (PSURs), and inspections of pharmacovigilance systems.

Marketing Authorisation Holders (MAHs) must report ICSRs occurring in Latvia directly to the EudraVigilance Human Post-Authorisation Module (EVPM) using the message-receiver identifier EVHUMAN. MAHs must also appoint a Qualified Person for Pharmacovigilance (QPPV) who lives and works within the European Union to be responsible for maintaining the pharmacovigilance system. If the QPPV is not resident in Latvia, a national level contact person for pharmacovigilance issues must be appointed. The national contact person should reside and work in Latvia, and have sufficient command of the Latvian language to ensure effective communication.

SAM exchanges information regarding pharmacovigilance issues (including adverse drug reactions) with MAHs and other stakeholders to support effective functioning of Latvia pharmacovigilance services.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing via E2B(R3)-compliant databases and integration with WHO Drug Dictionary (WHO DD) and MedDRA
  • Quality checks, medical reviews
  • Submission of cases in line with SAM/EU timelines (serious within ~15 days, non-serious within ~90 days)
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, maintaining RMPs and REMS in line with local and EU standards
  • Customized procedures to classify safety risks and propose risk minimization strategies
  • Assessment of potential risks and gaps, preparation of mitigation reports
  • Implementation of supplementary measures (e.g., Post-Authorization Safety Studies, observational studies, follow-ups)
  • Conveying risks via product labeling (e.g., SmPC) and Patient Information Leaflet (PIL)
• + Aggregate Reports
  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals or changes in risk from ICSRs, literature, agency websites, and aggregate reports
  • Use of internal tools/databases for detection and tracking
  • Reviewing safety signals (including PRAC recommendations)
  • Label update analysis
  • Recommendations for risk minimization
  • Preparation of signal management trackers and annual signal reports
• + Qualified Person for Pharmacovigilance (QPPV) / Local Contact Person Services
  • Review and sign-off of PSMF, Safety Data Exchange Agreement (SDEA), SOPs etc.
  • Retainer services for QPPV and deputy roles
  • Local safety responsible: national-level contact person when QPPV is not resident in Latvia
  • PV Quality Management System oversight, monthly reconciliations, medical reviews, signal surveillance meetings, communication & compliance metrics
• + PV Audit & Compliance
  • Review of compliance to SAM and EU guidelines, safety data exchange agreements, SOPs
  • Audit plans including mock audits to prepare organizations for inspections by SAM
  • Gap assessments of local PV personnel and processes
  • Training for staff on audits, inspections, and regulatory compliance