On 20 May 2026, Botswana Medicines Regulatory Authority (BoMRA) invited stakeholder comments on the proposed Medicines and Related Substances (General) Regulations, 2025 and Medicines and Related Substances (Fees, Levies and Penalties) Regulations, 2026, signaling a major step toward a more comprehensive regulatory framework for cosmetics and related products in Botswana. The proposed measures indicate a transition from a relatively limited oversight model to a structured system incorporating mandatory product listing, notification requirements, import and export controls, enhanced recordkeeping, inspections, and lifecycle regulatory fees. Under the proposed framework, cosmetic products imported into Botswana would become subject to registration, renewal, retention, and variation fees, while locally manufactured products would benefit from comparatively lower fee structures. This approach is expected to encourage local manufacturing and aligns with broader regional industrialization objectives and the goals of the African Continental Free Trade Area (AfCFTA). The proposals also emphasize greater supply chain transparency, product traceability, and regulatory accountability through strengthened documentation and electronic recordkeeping requirements. In addition, approval requirements and fees for advertising and promotional materials, including digital media, suggest increased oversight of cosmetic marketing claims.

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Botswana Medicines Regulatory Authority (BoMRA); Medicines and Related Substances (General) Regulations; Consultation; African Continental Free Trade Area (AfCFTA)