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Burkina Faso
Decree on the National Health Product Vigilance System & Order on the National Vigilance Commission
This legal framework for Burkina Faso establishes a national system for the vigilance of health products under the authority of the Minister of Health. The foundational decree creates the system to monitor adverse effects from medicines, vaccines, blood products, and cosmetics. A subsequent order operationalizes this system by creating the National Vigilance Commission. This order details the commission’s missions, its multi-stakeholder composition chaired by the Director General of Pharmacy, and its procedures for evaluating safety information and providing recommendations.
Use Cases
- Minister of Health – Oversee the National Vigilance System: To supervise the entire system, issue binding orders based on commission recommendations, and ensure its proper functioning and funding through the state budget.
- National Vigilance Commission – Evaluate and Recommend Action: To serve as the central body for evaluating safety information, reviewing reports from technical committees, and issuing official advice and recommendations to the Minister of Health for action.
- Director General of Pharmacy (DGPML) – Chair the National Commission: To preside over the National Vigilance Commission, lead its meetings, and act as the primary channel for transmitting the commission’s recommendations to the Minister of Health.
- Healthcare Professionals (“Notifiers”) – Fulfill Mandatory Reporting: To adhere to the mandatory obligation of declaring suspected adverse effects by completing and transmitting a notification form to a structure within the national vigilance system.
- Specialized Technical Committees – Conduct In-depth Analysis: To analyze specific types of vigilance data (e.g., for medicines, vaccines, blood products) and submit detailed reports to the National Commission for final evaluation.
- Pharmaceutical Companies – Participate in the Vigilance System: To operate as a key stakeholder within the system and comply with the national framework for monitoring and reporting adverse events related to their products.
Key takeaways you'll learn
The resource’s purpose is to establish a legal and organizational framework for a comprehensive national vigilance system in Burkina Faso to ensure the safe use of all health products by detecting, evaluating, and preventing adverse effects and related incidents.
- Broad Scope of “Health Products”: The vigilance system’s mandate extends beyond just medicines to include a wide range of “health products,” such as vaccines, blood and its derivatives, reagents, medical devices, and cosmetics.
- Mandatory Reporting Obligation: The decree establishes that the notification of suspected adverse effects is a mandatory declaration for authorized persons (“notifiers”), moving beyond a voluntary system.
- Multi-Tiered Organizational Structure: The system is organized into multiple levels, including a National Vigilance Commission at the top, supported by specialized technical committees and regional vigilance committees, creating a structured hierarchy for analysis and decision-making.
- Multi-Stakeholder National Commission: The National Vigilance Commission is intentionally composed of a wide range of stakeholders, including representatives from various health directorates, professional orders (physicians, pharmacists), consumer associations, industry, and traditional health practitioners.
- State-Funded System: The decree explicitly states that the operating costs for the national commission and its various committees are to be included in the state budget, ensuring public funding and government leadership.
