Pharmacovigilance is vital for ensuring drug safety and protecting patients. In France, strict local regulations guide pharmaceutical companies in meeting their legal obligations. For MAHs and Exploitants, understanding these requirements is essential for operating in the French market. Discover the key PV regulations and responsibilities unique to France in this insightful guide.
Role of the Local Reference Person for Pharmacovigilance
In France, a Local Person for PV, also referred to as the Reference Person for Pharmacovigilance (RPV), must be appointed by each company that authorizes and distributes medicinal products. This person must be a qualified Medical Doctor or Pharmacist, reside in France and have experience in PV. Their primary responsibilities include overseeing the local PV system, ensuring compliance with national regulations, and maintaining constant communication with both the QPPV and the Responsible Pharmacist (RP).
Collaboration Between Key Figures
In France, the Responsible Pharmacist, the QPPV, and the RPV must work closely together to ensure effective PV operations and compliance. While the QPPV oversees the PV system at the EU or global level and the RPV ensures local compliance in France, the RP plays a unique role in bridging the Exploitant’s activities with both local and global systems.
The RP is responsible for managing the Exploitant’s pharmaceutical and PV obligations within France, ensuring they meet the legal and regulatory standards. They collaborate with the QPPV and RPV through regular meetings, documented communication, and shared oversight of PV activities. The RP may delegate specific PV responsibilities to the RPV through a formal delegation agreement, such as a letter or matrix of responsibilities. However, the RP retains ultimate accountability for ensuring compliance and maintaining oversight of these activities.
This collaboration involves:
- Oversight and support: the RP supports the RPV in implementing local PV measures while ensuring alignment with the QPPV’s global strategies.
- Communication: regular discussions between the RP, QPPV, and RPV ensure all parties are aligned on safety signal detection, adverse event reporting, and risk minimization measures.
- Documentation: the functional relationships among the RP, QPPV, and RPV must be clearly defined in the local PSMF.
Reporting and Documentation
MAHs and Exploitants are required to report ADRs directly to EV and notify the ANSM about any safety information that could impact the benefit-risk assessment of the medicinal product. Notably, any off-label use in France that is not included in the RMP must be reported. Reporting medication errors and instances of drug abuse are subject to specific conditions. For example, if an error does not result in an adverse event, it is not obligatory to report it to ANSM.
French-Specific PSMF
A French or local PSMF must be developed unless the global PSMF already covers all national PV activities. This document is essential for describing the local PV system and is typically prepared by the RPV in collaboration with MAH representatives. Local signal detection and risk management systems are also mandatory and should be aligned with national legislation to monitor product safety.
Signal Detection and Risk Management
Even though signal detection is performed at a global level, the MAH or Exploitant is required to implement necessary measures to detect, validate, and assess safety signals at the national level. In cases where urgent safety signals are detected, they must notify ANSM and potentially the EMA within three days. The implementation of aRMMs must be translated and validated by the ANSM.
Quality Management and Business Continuity
MAHs and Exploitants must ensure their PV system is continuously effective and meets key performance indicators as part of their quality management system. This includes conducting internal audits, managing compliance with national and international regulations, and assuring the proper archiving of PV data for a minimum of 10 years. All systems and processes must also be validated to ensure they function correctly in the event of a crisis.
Compliance with France specific PV regulations is essential for pharmaceutical companies to operate smoothly within the French market. From the appointment of a local RPV to reporting and collaboration with key stakeholders, the requirements are designed to ensure patient safety and the continuous monitoring of medicinal products. Understanding these roles and responsibilities, along with the detailed reporting and documentation obligations, will help companies maintain compliance and contribute to a robust PV system in France.
Key Takeaways:
- Companies must appoint a LPPV/RPV who is a qualified MD or Pharmacist residing in France.
- The QPPV, RPV, and Responsible Pharmacist must work together closely, ensuring local compliance and bridging local and global systems.
- Adverse reactions, off-label use, and safety signals must be reported to ANSM promptly.
- A French-specific PSMF is needed unless global PSMF covers all local activities.
- Companies must ensure ongoing compliance through audits, KPIs, and proper archiving of PV data for at least 10 years.
