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Togo
Organizing the national pharmacovigilance system / Portant organisation du système national de pharmacovigilance
This 2008 Ministerial Order establishes the national pharmacovigilance system under the authority of the Directorate of Laboratory Pharmacies and Technical Equipment (DPLET). Its purpose is to monitor the risk of adverse effects resulting from the use of medicinal products and other products for human use. The system mandates the collection, recording, evaluation, and use of safety information for prevention. It defines the obligation for Marketing Authorization Holders (MAHs) to submit periodic reports and notify the authority of any international marketing restrictions or withdrawals.
Use Cases
- Directorate of Laboratory Pharmacies and Technical Equipment (DPLET) – Execute and Set Procedures: This body is responsible for the execution of the Order and setting subsequent procedures for declarations and periodic reports.
- Marketing Authorization Holders (MAHs) – Submit Periodic Safety Reports: MAHs or their local representatives are required to submit updated periodic pharmacovigilance reports.
- MAHs – Notify International Safety Changes: They must immediately inform the Director of Pharmacies of any suspension, withdrawal, or restriction of the product’s marketing authorization outside of Togo.
- Health Professionals – Report Adverse Effects: They are tasked with reporting adverse effects and collecting information concerning them, supporting the overall pharmacovigilance function.
- Minister of Health – Define Good Pharmacovigilance Practices (GVP): The Minister is responsible for issuing a separate order to define the GVP and the detailed procedures for collecting, verifying, and evaluating information.
- Clinical Trial Sponsors/Investigators – Follow Protocol Obligations: Reporting obligations for products under a protocol for therapeutic use or clinical trial are to be exercised according to the procedures set by that specific protocol.
Key takeaways you'll learn
The resource’s purpose is to legally establish the structure and scope of the national pharmacovigilance activities in Togo, emphasizing risk monitoring and the responsibilities of the regulatory body and MAHs.
- Legal Foundation: The national PV system is officially organized by a Ministerial Order (Arrêté) from 2008, based on the framework law on drugs and pharmaceuticals.
- Broad Scope: Pharmacovigilance is defined to cover the risk of adverse effects from medicinal products and products for human use.
- MAH Safety Obligations: Marketing Authorization Holders are required to report serious, unexpected adverse effects from their authorized products without delay.
- International Safety Intelligence: A specific obligation is placed on MAHs to notify the authority of any regulatory actions (e.g., suspension or withdrawal) taken outside of Togo.
- Tiered Legislation: While this Order establishes the system, the detailed procedures and the Good Pharmacovigilance Practices (GVP) are mandated to be defined by a subsequent, separate Order.
