Screening Report for New Medicine Applications for Registration

The checklist must be used by the applicant for all new product submissions for human medicines only from 01 October 2025.

This template shall be used on receipt of a new human medicine application for registration to verify that all the required information for evaluation has been provided to SAHPRA. It is also used for follow-up sequences that may be required for the new registration.

Verify if the applicant has completed all relevant fields on the received application form and ensured that all hyperlinks are included and tested for ease of navigation by the screener.

For a new sequence related to a response to screening queries, complete the product information and the relevant changes with hyperlinks.

Note that the greyed-out fields are not required for screening.

C – Compulsory