Quote from VigiServe Admin on November 28, 2020, 8:38 AM

The pharmacovigilance (PV) system in **Botswana** is established and aligned with **WHO** minimum standards for functional national PV systems, with ongoing development supported by regional (SADC/EAC) harmonization and WHO/Africa CDC initiatives. Botswana is a full WHO PIDM member and contributes Individual Case Safety Reports (ICSRs) to VigiBase via **VigiFlow**. The **Botswana Medicines Regulatory Authority (BoMRA)** (established under the Medicines and Related Substances Act 2013) is the primary regulatory body, overseeing registration, quality, safety, post-marketing surveillance, and PV through its **Department of Pharmacovigilance and Clinical Trials (PVCT)**.

Key guidelines include:
- **Pharmacovigilance Guidelines for Market Authorization Holders (MAHs)** (latest version 2020–2025, BOMRA-PCT-PV-P01-G02 Iss3 or later).
- **Pharmacovigilance Guidelines** (2009 foundational, with updates).
- **Guideline on Pharmacovigilance Inspection** (new risk-based version issued ~2025).

**Legal Framework and Governance**
- BoMRA coordinates the national PV system, including ADR/AEFI reporting, signal detection, risk assessment, inspections, alerts, and recalls.
- Emphasis on spontaneous reporting, active surveillance (e.g., for antiretrovirals, vaccines, high-risk products), hospital PV committees, and post-market quality/safety monitoring.

**Organization and Personnel**
- Market Authorization Holders (MAHs) must establish/maintain a PV system compliant with BoMRA guidelines.
- **Qualified Person for Pharmacovigilance (QPPV)**: Local QPPV is required (resident in Botswana; pharmacist or equivalent with PV experience; approved by BoMRA; primary contact for reporting/compliance).
- **Pharmacovigilance System Master File (PSMF)**: Required (MAH establishes/maintains; available for BoMRA inspections).

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- MAHs, HCPs, hospitals, patients, and others report suspected ADRs/AEFIs, quality issues, or medication errors via BoMRA channels (forms, electronic tools, or regional offices).
- **Timelines** (aligned with ICH/WHO and BoMRA guidelines):
- **Serious ICSRs** (unexpected or increased frequency/severity): Expedited within **15 calendar days** of receipt.
- **Non-serious ICSRs**: Within **90 calendar days** or periodic aggregates.
- Fatal/life-threatening cases or special situations (e.g., clinical trials): Often **7 days** for urgent reporting.
- Foreign ICSRs: Included in periodic reports if relevant.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- MAHs submit periodic safety reports (ICH E2C(R2)-like format).
- Frequency: Typically every **6 months** initially (post-approval), then **annually** or as specified by BoMRA (during renewals/variations/safety concerns).

**Risk Management Plans (RMP)**
- Required for new/high-risk products, biologics, or specific concerns (per BoMRA guidelines).
- Submit RMP with pharmacovigilance plan and risk minimization measures; updates for new risks or changes.

**Signal Management and Emerging Safety Issues**
- MAHs continuously monitor data; notify BoMRA of validated signals or emerging concerns promptly.
- BoMRA leads national signal detection and risk assessment.

**Clinical Trials-Related Safety Requirements**
Clinical trials require BoMRA approval (via Clinical Trial Application; aligned with ICH GCP principles).
- Sponsors monitor safety and report to BoMRA's Clinical Trials Unit.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting (ICH E2A-aligned):
- Fatal/life-threatening SUSARs: **7 calendar days**.
- Other serious unexpected SUSARs: **15 calendar days**.
- **Development Safety Update Reports (DSURs)**: Annual/periodic required (ICH E2F format), especially for ongoing trials.
- Reports via BoMRA channels (electronic/forms); sponsor responsibility for monitoring, causality assessment, DSMB (if applicable), insurance for trial-related injury, and communication to BoMRA/ethics committees.

**Additional Monitoring / Other Aspects**
- No black triangle scheme.
- Active surveillance for priority products (e.g., antiretrovirals, vaccines, high-risk drugs).
- Risk-based GVP inspections of MAH PV systems (new guideline ~2025).
- Patient/HCP reporting encouraged; electronic tools promoted.
- Focus on rational use, counterfeit detection, and public health programs.

Botswana's PV framework is WHO/SADC-aligned and maturing (mandatory local QPPV since recent updates, GVP inspections, electronic reporting) — more developed than many African peers but less prescriptive than full ICH/EU systems on routine PSUR frequency. It balances MAH obligations with national surveillance.

For precise, product- or trial-specific details (e.g., latest PVCT guidelines, forms, or timelines), consult **BoMRA** directly via bomra.co.bw (Pharmacovigilance and Clinical Trials section, downloads, or contacts), as requirements evolve (e.g., 2025 inspection guideline and reporting improvements). Companies operating in Botswana appoint a local QPPV and align with BoMRA guidelines for compliance.

 

Pharmaceutical companies and practitioners have specific obligations with regards to pharmacovigilance. BoMRA ensures patient safety by communicating with healthcare professionals and by monitoring the activity of Marketing Authorization in order to assess whether they are compliant with pharmacovigilance obligations.

What should be reported?

• All side effects should be reported. Report any side effect of ANY medicines and/or vaccines, whether prescribed by a doctor or bought without a prescription

• You can also report problems with; suspected pharmaceutical defect, lack of efficacy, counterfeits/fake medicines, medication errors etc

• Report all suspected ADRs associated with drug-drug, drug-food or drug-food supplements (including herbal and complementary products) interactions

• Report when there is a lack of efficacy or when suspected pharmaceutical defects are observed

How to Report Side Effects

• Contact your healthcare provider e.g. doctor, nurse, pharmacist, vet etc

• Your healthcare provider will fill out the ADR form and send it to BoMRA on your behalf

Report Adverse drug reactions (ADR) online

Contacts Details Postal Address Botswana Medicines Regulatory Authority Private Bag 2 Gaborone Station Botswana

Email: reportadr@bomra.co.bw Tel: +267 373 1753 Fax: +267 318 6254 Toll-Free: 0800 600 216