Guideline on Co-Applicancy

This guideline is intended to provide guidance to applicants who intend to apply as co-applicants for the registration of a medicine. It represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on managing applications for registration where there is more than one applicant who is jointly accountable for the overall quality, safety and efficacy of a medicine. SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine in keeping with the knowledge current at the time of evaluation. Alternative approaches may be used but these should be scientifically and technically justified. The SAHPRA is committed to ensure that all registered medicines are of the required quality, safety, and efficacy. It is important that applicants adhere to administrative requirements to avoid delays in the processing and evaluation of applications. Guidelines and application forms are available from the office of the Chief Executive Officer and the website.