Local Safety Representation in Regulatory Pharmacovigilance - Overview
Marketing Authorization Holders (MAHs) of medicinal products marketing their products in the European Economic Area (EEA) have a legal responsibility to establish a sound Pharmacovigilance (PV) system. This responsibility centers on the appointment of a Qualified Person for Pharmacovigilance (QPPV) and in some cases, a Local Responsible Person (LRP) for PV.
Qualified Person Responsible for Pharmacovigilance(QPPV)
The QPPV is an integral part of an MAH’s PV system in the EU. Their responsibilities encompass a wide range of critical tasks, including:
- Initiation 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 as per the current set-up has QPPVs existing in Germany and Poland, with a Deputy QPPV present in Romania
Local Responsible Person (LRP) for Pharmacovigilance
In addition to the QPPV, the UK-based pharmaceutical organizations may require the appointment of an LRP for PV, as may some other countries in the context of 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 a majority of 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.
Our tailor-made solutions offer services to meet the needs of clients, i.e. MAHs operating in pharmaceutical organizations.
Our advantages include:
- The team at Freyr has years of experience with regulatory PV and is well-informed on global PV regulations and best practices.
- Affiliate network across the globe provides us with expertise to meet QPPV and LRP needs both in EU and in other EEA regions.
- We deliberate on all the relevant regulations as well as guidelines to ensure that our clients meet all of their PV requirements effortlessly while mitigating risks effectively.
