The South African Health Products Regulatory Authority (SAHPRA) has updated its "Fee Schedule and Explanatory Notes" to renew human and veterinary medicine registrations, effective 17 February 2025. This update clarifies fees, submission procedures, payment compliance, and regulatory requirements to ensure transparency in the renewal process.
These changes align with the Medicines and Related Substances Act, 101 of 1965, and apply to all applications submitted after 13 February 2025.
1. Updated Fee Structure for Renewals
The renewal fees vary based on the product type and whether it is a New Chemical Entity (NCE) or a Generic Medicine.
Category A – Human Medicines
New Chemical Entities (NCEs): R34,000 per master application, R13,500 per line extension (max 2 per application).
Generic Medicines: R31,600 per master application, R9,600 per line extension (max 2 per application).
Category C – Veterinary Medicines
New Chemical Entities (NCEs): R34,000 per master application, R13,500 per line extension (max 2 per application).
Generic Medicines: R31,600 per master application, R9,600 per line extension (max 2 per application).
The Masters, duplicates, replicas, and clones are charged separately based on whether they are an NCE or generic product. For products with a master file and more than two line extensions, only the master and two extensions will be charged.
2. Payment and Submission Guidelines
SAHPRA has introduced strict compliance measures to ensure smooth processing of renewal applications:
✅ Proof of Payment Requirement:
All applications must include proof of payment in Module 1.2.2.1.
Applications submitted without valid payment proof will be rejected.
✅ Closing Sequence for Approved Applications:
If a renewal application has already been submitted and approved, a closing sequence must be submitted with proof of payment.
Submission type: "Renewal"
Sequence type: "Closing Information"
SAHPRA will issue a revised registration certificate after verifying the payment.
✅ Renewal Applications with Amendments: If the product has changed (e.g., formulation updates, name changes, or deletions) since submission, the closing sequence must also include:
Updated Application Form (Module 1.2.1)
Updated Medicine Register Details (Module 1.5.2.2)
Proof of SAHPRA approvals for these changes (Modules 1.0.3 and 1.5.2.2.1)
✅ Payments for Pending Queries:
If an application has received a query letter, the response must include proof of payment in Module 1.2.2.1.
✅ Reference Codes for Payments:To ensure correct processing, payments must use the following reference codes:
BI RNW/ → for biological medicines
HU RNW/ → for human medicines
VT RNW/ → for veterinary medicines
3. Regulatory Compliance and Consequences of Non-Payment
Renewal applications submitted without proper payment will be invalid and rejected.
Expired registrations due to non-renewal may require a new application for market re-entry, leading to delays and additional costs.
Companies must ensure that payments and renewal applications are submitted at least six months before expiry to avoid disruptions.
For further clarifications, applicants can contact the SAHPRA Renewals Team at renewals@sahpra.org.za.
SAHPRA's 2025 fee updates aim to streamline the renewal process, improve regulatory compliance, and ensure that all registered medicines remain safe, effective, and available in the South African market. 🔗 For full details, visit: SAHPRA Official Website
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