Local Safety Representation in Regulatory Pharmacovigilance - Overview
Marketing Authorization Holders (MAHs) of medicinal products authorized for marketing in the European Economic Area (EEA) have a crucial legal responsibility to establish a robust Pharmacovigilance (PV) system. Central to this obligation is the appointment of a Qualified Person for Pharmacovigilance (QPPV) and, in some cases, a Local Responsible Person (LRP) for PV.
Qualified Person for Pharmacovigilance (QPPV)
The QPPV serves as the cornerstone of an MAH’s PV system in the EU. Their responsibilities encompass a wide range of critical tasks, including:
- Establishment and maintenance of the MAH’s PV system.
- 24/7 availability as the single PV point of contact for Regulatory authorities.
- Monitoring product safety and emerging concerns.
- Oversight of the PV system's functioning and quality.
The QPPV must reside and operate within a member state of the EEA. Freyr currently boasts of a QPPV based in Germany and Poland, with a Deputy QPPV stationed in Romania.
Local Responsible Person (LRP) for Pharmacovigilance
In addition to the QPPV, certain countries may require the appointment of an LRP for PV, especially in the context of the UK post-Brexit. LRPs are tasked with specific local-level responsibilities, including:
- Processing Individual Case Safety Reports (ICSR) at the national level
- Local submissions of regulatory documents.
- Implementation of additional Risk Minimization Measures (aRMM).
- Acting as a liaison between the MAH and local Regulatory authorities.
LRPs must be residents of the country where their services are required and possess fluency in the local language. Freyr, leveraging its extensive affiliate network, can provide LRP support for most EU countries, ensuring compliance with local PV requirements.
Local Safety Representation in Regulatory Pharmacovigilance
Freyr specializes in delivering top-notch pharmacovigilance services, including:
- QPPV support: From establishing PV systems to ensuring Regulatory compliance, Freyr’s QPPV services are designed to meet the highest standards of quality and reliability.
- LRP support: Our team of experts assists clients in appointing LRPs and navigating the complex landscape of local PV requirements, guaranteeing adherence to all relevant regulations.
- Training and consulting: Freyr offers comprehensive training programs and consulting services to empower clients with the knowledge and tools necessary for effective PV management.
Freyr offers a comprehensive suite of services tailored to meet the diverse needs of MAHs operating in the pharmaceutical industry. Our advantages include:
- With years of experience in Regulatory pharmacovigilance, Freyr boasts a team of seasoned professionals well-versed in global PV regulations and best practices.
- Our extensive affiliate network spans the globe, enabling us to provide tailored solutions for QPPV and LRP requirements not only within the EU but also in regions outside the EEA.
- We prioritize compliance with all relevant regulations and guidelines, ensuring that our clients meet their PV obligations seamlessly while mitigating risks effectively.
