25 Jan Pilot: BAU new medicine applications for registration
Posted at 10:40h
in
This document has been archived....
Archive
25 Jan eCTD Implementation roadmap communication
Posted at 10:38h
in
This document has been archived.
Archives
Download Version 2 (9.127)Date updated
...25 Jan BAU Variations Communication
Posted at 10:36h
in
This document is intended to provide communication to applicants wishing to submit variations to existing registrations. This will be a “living document” and will be updated. Kindly note that this is an interim document and that the information will be incorporated into a General Information...
25 Jan Reliance Guideline
Posted at 10:33h
in
This guideline is intended to provide recommendations to applicants wishing to submit new registration applications, as well as variations, for reliance review-based evaluation. It represents the Authority’s current thinking on the safety, efficacy and quality of medicines. It is not intended as an exclusive approach....
25 Jan Guideline for Good Manufacturing Practice
Posted at 10:30h
in
This document is intended to serve as guidance on the requirements for Good Manufacturing Practice (GMP) in South Africa. This guideline is not intended as an exclusive approach....
25 Jan Availability of medicines for use in a Public Health Emergency (PHE)
Posted at 10:24h
in
This guideline provides recommendations to applicants who intend to submit applications for the registration or authorisation of medicines intended to be available to those affected by a public health emergency. It represents the current thinking of the South African Health Products Regulatory Authority (the Authority)...
25 Jan Guideline for the API Master File (APIMF) Procedure
Posted at 10:20h
in
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines and variations. It represents the Authority’s current thinking on medicines' safety, efficacy and quality. It is not intended as an exclusive approach....
25 Jan Guideline for submission in eCTD format
Posted at 10:18h
in
This document has been archived....
25 Jan eCTD Validation Criteria
Posted at 10:17h
in
This document is intended to provide requirements to applicants wishing to submit applications for the registration of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained....