Fill out the form below to receive the complete PDF guide directly in your inbox. This resource provides clear, step-by-step guidance to help you make the most of the information we’ve prepared for you.
Sierra Leone
GUIDELINES FOR MAH REQUIREMENTS FOR QUALIFIED PERSONS FOR PHARMACOVIGILANCE-Sierra Leone
This guideline outlines the mandatory requirements for Marketing Authorization Holders (MAHs) regarding the designation and responsibilities of the Qualified Person for Pharmacovigilance (QPPV). The QPPV must be permanently and continuously available, medically or pharmaceutically qualified, and possess adequate knowledge of the principles of pharmacovigilance. The MAH is obliged to provide the QPPV with the necessary support, including training, access to critical data, and quality systems. Failure to comply with these requirements may result in severe sanctions, including fines or the suspension of product registration.
Use Cases
- Marketing Authorisation Holders (MAHs) – Designate and Support QPPV: They must ensure the QPPV has sufficient support (personnel, access to systems/data) and sufficient training to fulfill their responsibilities.
- QPPV – Oversee the PV System Master File (PSMF): The QPPV must ensure the continuous maintenance of the Pharmacovigilance System Master File (PSMF) which accurately and promptly reflects the MAH’s PV system.
- QPPV – Act as the Single Contact Point: The QPPV must serve as the single contact point for the Pharmacy Board of Sierra Leone (PBSL) on all pharmacovigilance matters.
- QPPV – Ensure Comprehensive Safety Reporting: They are responsible for overseeing the complete and timely reporting of both domestic (Sierra Leone) spontaneous reports (serious and non-serious) and published reports of suspected ADRs.
- PBSL – Impose Sanctions: The Board may impose sanctions, including administrative penalties (fines) or suspension of product registration, on MAHs who fail to comply with QPPV requirements.
- MAHs – Inform the Board of QPPV Changes: The MAH must notify the PBSL in advance of any replacement of the QPPV, providing the name and contact details of the new QPPV.
Key takeaways you'll learn
The resource’s purpose is to formalize the central role of the QPPV in the MAH’s pharmacovigilance activities, ensuring that MAHs have a single, qualified, and accountable professional overseeing drug safety in Sierra Leone.
- Mandatory Local Presence/Availability: The QPPV must be permanently and continuously available (24/7), with a clear requirement for a local contact person and access to a deputy when absent.
- Required Qualifications: The QPPV must be medically or pharmaceutically qualified, or have a relevant qualification deemed acceptable, along with adequate knowledge of the principles of pharmacovigilance.
- Oversight of Reporting and PSMF: Core QPPV duties include overseeing the quality management system for PV, ensuring full compliance with reporting timelines, and the maintenance of the PSMF.
- Scope of Required Reports: The QPPV must ensure the submission of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and the mandatory inclusion of a line-listing of all domestic spontaneous reports (serious and non-serious).
- Penalties for Non-Compliance: Non-adherence to the QPPV requirements is subject to sanctions by the PBSL, including fines and the ultimate penalty of suspension or revocation of the marketing authorization.
