Quote from VigiServe Admin on November 28, 2020, 6:26 AMThe pharmacovigilance (PV) system in **Mauritius** is functional and aligned with **WHO** minimum standards, with ongoing strengthening through WHO support (e.g., VigiMobile/VigiFlow training, digital tools, and standardized forms). Mauritius is a full WHO PIDM member, contributing to VigiBase. The system focuses on spontaneous ADR/AEFI reporting, signal detection, and safety monitoring, particularly in public health programs (e.g., vaccines, antiretrovirals).
**Legal Framework and Governance**
- Primary authority: **Ministry of Health and Wellness (MOHW)**, with the **National Pharmacovigilance Centre (NPC)** / **National Pharmacovigilance Committee** (established under the **Clinical Trials Act 2011** and related regulations).
- Key law: **Clinical Trials Act 2011** (provides for NPC functions, including ADR collection and monitoring).
- No comprehensive standalone national Good Pharmacovigilance Practices (GVP) guide is prominently public beyond WHO-aligned tools and basic directives; operations follow WHO guidelines, with regional SADC influences.
- NPC collects reports, assesses causality (e.g., WHO-UMC method), detects signals, and recommends actions (e.g., alerts, recalls).**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/importers/distributors must monitor safety and report ADRs to NPC/MOHW.
- No strict mandatory local **Qualified Person for Pharmacovigilance (QPPV)** or resident PV contact is detailed in public guidelines (system relies more on national coordination and HCP reporting than stringent MAH-level obligations).
- No formal **PV System Master File (PSMF)** registration/location mandate.**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- HCPs (primary reporters), hospitals, patients, and MAHs report suspected ADRs (serious/unexpected prioritized), medication errors, quality issues, or lack of efficacy to NPC (via standardized forms, online link at health.govmu.org, email phcovigilmru@govmu.org, or postal).
- Timelines: Not rigidly codified with fixed calendar days in prominent public sources (follows general WHO expectations); **prompt** reporting encouraged for serious/unexpected events to enable signal detection. Serious cases prioritized (regional SADC practice often aligns with 15 days for serious).
- Reports analyzed for signals/causality; feed into national system and VigiBase.**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- No routine mandatory periodic submissions detailed publicly for all products.
- Safety updates may be required during registration/renewals, variations, or on request (aligned with basic WHO formats).**Risk Management Plans (RMP)**
- Not a standard mandatory requirement for all products.
- Risk assessment handled reactively through NPC surveillance and MOHW decisions (e.g., for high-priority biologics/vaccines).**Signal Management and Emerging Safety Issues**
- NPC conducts ongoing surveillance and signal detection.
- MAHs monitor data and notify significant/emerging issues promptly (no fixed 5–45 day timelines publicly specified beyond general promptness).**Clinical Trials-Related Safety Requirements**
Clinical trials require MOHW approval (via **Clinical Research Regulatory Council (CRRC)**, **Ethics Committee (EC)**, and **Pharmacovigilance Committee** under the **Clinical Trials Act 2011**; aligned with international norms).
- Sponsors monitor safety and report serious adverse events/SAEs.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)** or equivalent: Expedited reporting required (aligned with international/ICH E2A norms; typically **7–15 days** for serious unexpected, faster for fatal/life-threatening; trial-specific or per approval rather than rigidly codified nationally).
- No dedicated national electronic system (e.g., no EudraVigilance/CTIS); reports submitted directly to MOHW/NPC (forms/email).
- Periodic safety reporting: **Development Safety Update Reports (DSURs)** or annual updates may be required/requested (ICH E2F or WHO formats), especially for ongoing trials.
- Sponsor responsibility for monitoring, causality assessment, and communication to authorities/ethics committees/CRRC.**Additional Monitoring / Other Aspects**
- No black triangle/additional monitoring scheme.
- Strong focus on spontaneous reporting from HCPs/institutions, quality surveillance (substandard/falsified medicines), and public health programs.
- Inspections/audits by MOHW possible; ADR reporting volumes historically low (under-reporting common), but improving with 2023 guideline rollout, training, digital tools, and WHO support (targeted boost by end-2025).Mauritius's PV framework is **functional but minimalistic** and developing — no stringent MAH obligations like mandatory local QPPV/PSMF/RMP for all, routine PSUR cycles, or highly detailed timelines compared to more advanced systems. It prioritizes national coordination, spontaneous reporting, and integration into health programs over complex industry bureaucracy.
For precise, product- or trial-specific requirements (e.g., current ADR forms/guidelines, exact timelines, or clinical trial submissions under Clinical Trials Act 2011), consult the **Ministry of Health and Wellness** directly via health.govmu.org (Pharmacovigilance section, online reporting link, or email phcovigilmru@govmu.org) or WHO partners, as the system continues to strengthen (e.g., digital adoption, training, and reporting targets through 2025–2026). Companies operating in Mauritius typically align with WHO minimums and reference regional standards (e.g., SADC) for compliance.
The National Pharmacovigilance Committee in Mauritius was established in December 2011 and Mauritius became a full member of the WHO Programme for International Drug Monitoring in 2014. It functions to manage and address any potential safety and quality issues that could arise from the use of health products marketed in Mauritius.
How to report?
Send to:
National Pharmacovigilance Committee 10th Floor, Emmanuel Anquetil Building Port-Louis
E-Mail: phcovigilmru@govmu.org
The pharmacovigilance (PV) system in **Mauritius** is functional and aligned with **WHO** minimum standards, with ongoing strengthening through WHO support (e.g., VigiMobile/VigiFlow training, digital tools, and standardized forms). Mauritius is a full WHO PIDM member, contributing to VigiBase. The system focuses on spontaneous ADR/AEFI reporting, signal detection, and safety monitoring, particularly in public health programs (e.g., vaccines, antiretrovirals).
**Legal Framework and Governance**
- Primary authority: **Ministry of Health and Wellness (MOHW)**, with the **National Pharmacovigilance Centre (NPC)** / **National Pharmacovigilance Committee** (established under the **Clinical Trials Act 2011** and related regulations).
- Key law: **Clinical Trials Act 2011** (provides for NPC functions, including ADR collection and monitoring).
- No comprehensive standalone national Good Pharmacovigilance Practices (GVP) guide is prominently public beyond WHO-aligned tools and basic directives; operations follow WHO guidelines, with regional SADC influences.
- NPC collects reports, assesses causality (e.g., WHO-UMC method), detects signals, and recommends actions (e.g., alerts, recalls).
**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/importers/distributors must monitor safety and report ADRs to NPC/MOHW.
- No strict mandatory local **Qualified Person for Pharmacovigilance (QPPV)** or resident PV contact is detailed in public guidelines (system relies more on national coordination and HCP reporting than stringent MAH-level obligations).
- No formal **PV System Master File (PSMF)** registration/location mandate.
**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- HCPs (primary reporters), hospitals, patients, and MAHs report suspected ADRs (serious/unexpected prioritized), medication errors, quality issues, or lack of efficacy to NPC (via standardized forms, online link at health.govmu.org, email phcovigilmru@govmu.org, or postal).
- Timelines: Not rigidly codified with fixed calendar days in prominent public sources (follows general WHO expectations); **prompt** reporting encouraged for serious/unexpected events to enable signal detection. Serious cases prioritized (regional SADC practice often aligns with 15 days for serious).
- Reports analyzed for signals/causality; feed into national system and VigiBase.
**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- No routine mandatory periodic submissions detailed publicly for all products.
- Safety updates may be required during registration/renewals, variations, or on request (aligned with basic WHO formats).
**Risk Management Plans (RMP)**
- Not a standard mandatory requirement for all products.
- Risk assessment handled reactively through NPC surveillance and MOHW decisions (e.g., for high-priority biologics/vaccines).
**Signal Management and Emerging Safety Issues**
- NPC conducts ongoing surveillance and signal detection.
- MAHs monitor data and notify significant/emerging issues promptly (no fixed 5–45 day timelines publicly specified beyond general promptness).
**Clinical Trials-Related Safety Requirements**
Clinical trials require MOHW approval (via **Clinical Research Regulatory Council (CRRC)**, **Ethics Committee (EC)**, and **Pharmacovigilance Committee** under the **Clinical Trials Act 2011**; aligned with international norms).
- Sponsors monitor safety and report serious adverse events/SAEs.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)** or equivalent: Expedited reporting required (aligned with international/ICH E2A norms; typically **7–15 days** for serious unexpected, faster for fatal/life-threatening; trial-specific or per approval rather than rigidly codified nationally).
- No dedicated national electronic system (e.g., no EudraVigilance/CTIS); reports submitted directly to MOHW/NPC (forms/email).
- Periodic safety reporting: **Development Safety Update Reports (DSURs)** or annual updates may be required/requested (ICH E2F or WHO formats), especially for ongoing trials.
- Sponsor responsibility for monitoring, causality assessment, and communication to authorities/ethics committees/CRRC.
**Additional Monitoring / Other Aspects**
- No black triangle/additional monitoring scheme.
- Strong focus on spontaneous reporting from HCPs/institutions, quality surveillance (substandard/falsified medicines), and public health programs.
- Inspections/audits by MOHW possible; ADR reporting volumes historically low (under-reporting common), but improving with 2023 guideline rollout, training, digital tools, and WHO support (targeted boost by end-2025).
Mauritius's PV framework is **functional but minimalistic** and developing — no stringent MAH obligations like mandatory local QPPV/PSMF/RMP for all, routine PSUR cycles, or highly detailed timelines compared to more advanced systems. It prioritizes national coordination, spontaneous reporting, and integration into health programs over complex industry bureaucracy.
For precise, product- or trial-specific requirements (e.g., current ADR forms/guidelines, exact timelines, or clinical trial submissions under Clinical Trials Act 2011), consult the **Ministry of Health and Wellness** directly via health.govmu.org (Pharmacovigilance section, online reporting link, or email phcovigilmru@govmu.org) or WHO partners, as the system continues to strengthen (e.g., digital adoption, training, and reporting targets through 2025–2026). Companies operating in Mauritius typically align with WHO minimums and reference regional standards (e.g., SADC) for compliance.
The National Pharmacovigilance Committee in Mauritius was established in December 2011 and Mauritius became a full member of the WHO Programme for International Drug Monitoring in 2014. It functions to manage and address any potential safety and quality issues that could arise from the use of health products marketed in Mauritius.
How to report?
Send to:
National Pharmacovigilance Committee 10th Floor, Emmanuel Anquetil Building Port-Louis
E-Mail: phcovigilmru@govmu.org