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Mauritius
REPORTING GUIDELINES FOR MAURITIUS
The National Pharmacovigilance Committee of Mauritius has adopted the ICH guidelines for reporting Adverse Drug Reactions (ADRs). It mandates strict, tiered reporting deadlines: Serious Adverse Drug Reactions (SADRs) occurring locally must be reported within 7 days , while all non-serious ADRs have a 30-day deadline. Reporting is mandatory for pharmaceutical companies, manufacturers, wholesalers, and healthcare professionals. Submissions are made on the CIOMS form or the Yellow Card via email or a dedicated online portal for ADRs and quality issues.
Use Cases
- Pharmaceutical Companies, Manufacturers, Wholesalers – Ensure Regulatory Compliance: They must report Serious Adverse Drug Reactions (SADRs) that occurred in Mauritius to the National Pharmacovigilance Committee within 7 days.
- Health Care Professionals (HCPs) – Report Comprehensive Range of Products: They must report on all types of medicines, including vaccines, blood factors, immunoglobulins, herbal medicines, and homeopathic remedies, regardless of where the product is dispensed.
- National Pharmacovigilance Committee (NPC) – Evaluate Reports from All Stakeholders: The Committee is responsible for examining reports for ADRs occurring within Mauritius, accepting reports from both Health Care Professionals and consumers.
- Sponsors/Drug Agencies – Communicate International Safety Changes: They must notify the NPC of any evaluation reports, revaluation reports, or marketing suspension actions taken by other pharmacovigilance centres or drug agencies within 15 calendar days.
- Reporters (All Stakeholders) – Submit Serious Adverse Drug Reactions: They must prioritize the reporting of reactions resulting in patient death , life-threatening events , or those causing congenital abnormality.
- Reporters (All Stakeholders) – Utilize Digital Reporting Channels: They can submit reports using the CIOMS form via email or use the online portal for Adverse Drug Reactions (ADRs) or Quality Issues.
Key takeaways you'll learn
The resource’s purpose is to establish clear and rapid safety reporting obligations for all stakeholders in Mauritius, ensuring the timely submission and evaluation of domestic and international drug safety information to the National Pharmacovigilance Committee.
- International Guideline Adoption: The National Pharmacovigilance Committee has formally adopted the ICH guidelines for the reporting of Adverse Drug Reactions (ADRs), aligning Mauritius with global pharmacovigilance standards.
- Tiered Reporting Timelines: Two distinct timelines are enforced: 7 days for all Serious Adverse Drug Reactions (SADRs) and 30 days for all non-serious ADRs occurring within the Mauritian territory.
- Expanded Product Scope: Reporting is explicitly required for a wide range of products, including traditional/non-conventional treatments like herbal medicines and homeopathic remedies, in addition to vaccines and blood products.
- Direct Consumer Reporting: The system is designed to accept and examine reports originating from consumers as well as Health Care Professionals (HCPs) for ADRs occurring within Mauritius.
- Requirement for Global Safety Intelligence: The NPC mandates the reporting of significant international regulatory actions (evaluation, revaluation, or marketing suspension by other drug agencies) within a swift 15 calendar days.
