SAHPRA ECTD Specification 3.1 and Guidance for Module 1 and Regional Information

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration, as well as variations, of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications. Guidelines and application forms are available from South African Health Products Regulatory Authority website.