Pharmacovigilance Services in Poland

Operating in Poland requires robust alignment with EU pharmacovigilance legislation alongside country-specific expectations from URPL. Beyond centralised EU compliance, Polish authorities expect locally accessible safety oversight, timely adverse event reporting, and clear accountability for pharmacovigilance operations.

DDReg provides end-to-end Pharmacovigilance Services in Poland, supporting pharmaceutical, biotech, and life sciences companies with URPL pharmacovigilance services, local PV contact support, and inspection-ready drug safety systems. Our approach combines EU-level governance with practical, Poland-specific execution.

All MAHs must appoint a Qualified Person for Pharmacovigilance (QPPV) located within the EU/EEA, in accordance with EU legislation. The QPPV retains overall responsibility for the pharmacovigilance system.

While Poland does not mandate a separate national QPPV, URPL expects a local pharmacovigilance contact to ensure effective national oversight.

• Typically, a pharmacist or physician
• Fluent in Polish
• Accessible to URPL for safety-related communication
• Knowledgeable in local reporting practices and timelines

• Handling URPL pharmacovigilance reporting
• Supporting adverse event follow-ups and authority queries
• Coordinating Poland-specific activities with the EU QPPV
• Supporting PSMF maintenance, SDEA oversight, and compliance checks
• Ensuring implementation of RMP Poland submission requirements

DDReg provides Local QPPV Services Poland and LCPPV services Poland, ensuring seamless EU-to-local pharmacovigilance integration.

• Pharmaceutical Law (Prawo farmaceutyczne)
  Poland’s primary legislation governing medicinal products, incorporating EU pharmacovigilance directives, including Directive 2001/83/EC.
• EU Regulations & Directives
  Including Regulation (EC) No 726/2004 and EU GVP Modules I–XVI, directly applicable or transposed into Polish law.
• URPL Guidelines & Communications
  Country-specific instructions on adverse event reporting formats, submission processes, and risk management obligations.
• Official Journal of Laws (Dziennik Ustaw)
  Publishes enacted laws and amendments relevant to pharmacovigilance compliance in Poland.

• + Individual Case Safety Report (ICSR) Management
  • End-to-end ICSR intake, medical assessment, and quality review
  • Management of serious and non-serious adverse events in line with EU and Polish timelines
  • MedDRA coding and Poland-compliant safety narratives
  • Submission via EudraVigilance with URPL pharmacovigilance reporting coordination
  • Follow-up management and authority query handling
• + Aggregate Safety & Periodic Reporting
  • Preparation and review of PSURs, PBRERs, and other aggregate reports
  • Integration of Poland drug safety services data into EU and global submissions
  • Scientific benefit–risk evaluation aligned with EMA and URPL expectations
  • Inspection-ready documentation and consistency checks
• + Signal Detection & Risk Management
  • Continuous signal detection and safety trend analysis
  • Local safety impact assessment for the Polish market
  • Support for RMP Poland submission, updates, and lifecycle maintenance
  • Coordination of risk minimisation activities and safety communications
• + PV System Setup, Maintenance & Audit Support
  • Design and maintenance of Polish pharmacovigilance services frameworks
  • SOP development aligned with EU GVP and Polish legal requirements
  • Gap analysis, mock audits, and URPL inspection preparedness
  • Ongoing compliance support for EU and non-EU MAHs
• + QPPV, LCPPV & Local Pharmacovigilance Support
  • Local QPPV Services Poland integrated with EU oversight models
  • Appointment and management of Local Contact Person Pharmacovigilance Poland
  • URPL authority communication and inspection support
  • 24/7 safety oversight for global portfolios
• + Polish Medical Literature Monitoring
  • Polish medical literature monitoring across local journals and scientific sources
  • Case identification, triage, and processing compliant with EU GVP Module VI
  • Integration of local literature cases into global safety databases
  • Ongoing compliance with URPL expectations

Why Choose DDReg as Your Pharmacovigilance Partner in Poland?

• Proven expertise in Pharmacovigilance services Poland MAHs rely on
• Deep understanding of URPL pharmacovigilance services and EU GVP execution
• Scalable pharmacovigilance outsourcing Poland models
• Strong local execution combined with global pharmacovigilance governance
• Trusted by companies seeking reliable Poland drug safety services with inspection readiness