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Togo
NOTE DE PHARMACOVIGILANCE / Note N° 0022/2018/
This 2018 Pharmacovigilance Note from the Direction de la Pharmacie, du Médicament et des Laboratoires (DPML) informs all Marketing Authorization Holders (MAHs) in Togo of new mandatory conditions for submitting Adverse Drug Events (EIM). It establishes tiered submission deadlines for spontaneous cases (ICSRs). Serious cases (national and non-national) must be submitted within 15 calendar days, while non-serious national cases are due within 90 calendar days in the CIOMS format. The note took effect on March 1, 2018.
Use Cases
- Marketing Authorization Holders (MAHs) – Submit Serious ICSRs: They must submit all Serious spontaneous case reports (ICSRs), both national and non-national, within 15 calendar days.
- MAHs – Submit Non-Serious National ICSRs: They are required to submit non-serious spontaneous cases occurring nationally within 90 calendar days.
- CNPV (National Pharmacovigilance Centre) – Receive Immediate Alert: The CNPV must be informed immediately, and at the latest within 72 hours, of national serious cases by telephone or email.
- MAHs – Utilize PSUR for Non-National Non-Serious Cases: Non-national non-serious cases are not submitted individually but are required to be analyzed within the Periodic Safety Update Reports (PSURs).
- MAHs – Utilize CIOMS Format: Both serious and non-serious national spontaneous reports must be submitted using the CIOMS format.
- MAHs – Submit PSURs via CD-ROM: Periodic Safety Update Reports (PSURs) are submitted via CD-ROM according to the European frequency.
Key takeaways you'll learn
The resource’s purpose is to standardize and enforce specific, strict deadlines for the submission of individual case safety reports (ICSRs) and periodic reports by Marketing Authorization Holders (MAHs) in Togo.
- Fixed Deadlines: The note sets clear, non-negotiable submission deadlines of 15 calendar days for all Serious ICSRs (national and non-national).
- 72-Hour Rapid Alert: A separate requirement exists for immediate notification of national serious cases to the CNPV, no later than 72 hours.
- CIOMS Format Mandatory: The designated format for submitting spontaneous case reports is the CIOMS form.
- PSUR Submission Method: Periodic Safety Update Reports (PSURs) are submitted on CD-ROM following the European submission frequency.
- Longer Deadline for Non-Serious Cases: Non-serious national spontaneous cases are given a longer reporting window of 90 calendar days.
