Screening Checklist for New Medicine Applications for Registration

The screening checklist is used to verify that all required information has been provided to SAHPRA to evaluate an application for the new registration of a medicinal product for human use. The applicant must ensure that all relevant fields are completed and hyperlinked. For a new sequence related to a response to screening queries, complete the product information and the relevant changes with hyperlinks.

The Screening Report for New Medicine Applications for Registration published in September 2025 is valid until the 31 March 2026, and it will be replaced  by the screening checklist from 1 April 2026. As a result, Dossiers submitted from 1 April 2026 must have the Screening Checklist for New Medicine Applications for Registration.