This document should be completed by the applicant to ensure the inclusion of all necessary Bioequivalence Trial information.
Residues Overall Summary (ROS) should be completed for pharmaceutical products intended for food producing species.
The formulation and API characteristics, including the route of administration and species, are factors which may affect requirements to waive bioequivalence studies (i.e., to compare the rate and extent of absorption between two formulations containing same active substances). Applicants must submit the following relevant information...
This document has been archived.
This document has been archived.
This document provides guidance on access to unregistered medicines for animal use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and clarifies the mandate, intent and scope of this section and Regulation 29 of the...
This document has been archived.
This document is intended to provide guidance on implementation of renewals for medicine registration. This will be a “living document” and will be updated as required.
Version 1...