Regulatory & Compliance
Operating within South Africa's healthcare and legal framework
A structured approach aligned with SAHPRA, the Department of Health, and the South African Pharmacy Council.
A Regulated Operating Environment
Bassani Health operates within a highly regulated healthcare environment, aligning its operations with South Africa's primary regulatory authorities. These include:
- The South African Health Products Regulatory Authority (SAHPRA)
- The National Department of Health
- The South African Pharmacy Council (SAPC)
These bodies collectively govern the cultivation, manufacture, distribution, and dispensing of scheduled medicines in South Africa.
A Multi-Layered Regulatory System
South Africa's cannabis regulatory environment is structured across multiple authorities, each responsible for different aspects of pharmaceutical and healthcare compliance.
SAHPRA
Regulates cannabis cultivation for scheduled substances, as well as the manufacture and registration of medicines.
National Department of Health
Oversees manufacturing pharmacy licensing.
South African Pharmacy Council
Governs pharmacy compliance, dispensing, and professional standards.
A Complete Regulatory Licence Stack
Based on publicly available regulatory records and verified documentation, Bassani Health's operations span all key licensing layers required to operate within a pharmaceutical cannabis framework.
Due to the fragmented nature of regulatory systems across these authorities, no single public database reflects combined licence positions across operators. However, based on available public records, Bassani appears uniquely positioned with a complete, integrated licence stack supporting end-to-end regulated operations.
Operational Capability Within the Framework
Bassani Health's integrated licence position enables:
Regulatory Oversight
Regulatory and compliance functions at Bassani Health are led by experienced pharmaceutical professionals.
Henk Krebs
Head of Quality Assurance & Regulatory Affairs
Henk Krebs is a qualified pharmacist with additional legal training and extensive experience in pharmaceutical compliance, regulatory strategy, and healthcare systems. He leads Quality Assurance and Regulatory Affairs at Bassani Health, ensuring alignment with SAHPRA, the Department of Health, and the South African Pharmacy Council. His role includes:
- Oversight of GMP and quality systems
- Management of regulatory pathways
- Ensuring compliance across the integrated platform
A Compliance-First Approach
"Within the framework, not around it"
Bassani Health's operating model is built on a fundamental principle: To operate entirely within the regulatory framework. This includes:
Operate Within the Framework
If you are a healthcare provider, pharmacy, or industry participant seeking to operate within a compliant cannabis framework, Bassani Health provides structured pathways aligned with regulatory requirements.
