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...
This guideline is intended to provide recommendations to applicants wishing to submit an application for a licence to import and /or distribute substances listed in the schedules in terms of the Medicines Act, intended for use in the manufacturing and/or compounding of medicines or scheduled...
This Guideline sets out requirements for radiation safety associated with the use of therapeutic devices emitting ionizing radiation. The Hazardous substances Act, 1973 (Act 15 of 1973) and Regulations (No R1332 of 3 August 1973)....
This guideline sets out the requirements and recommendations when applying for a license to import any electronic device emitting ionizing radiation. The Hazardous Substances Act 15, 1973....
This communication is for Stakeholders to be aware of the South African Health Products Regulatory Authority (SAHPRA) Clinical Trials Committee meeting dates and the submission dates for the year of 2024. ...
SAHPRA has launched an Online Medicines Directory. Please visit: www.medsinfo.sahpra.org.za The Online Medicines Directory has been launched for Schedule 0-2. The job is to increase awareness and use of the directory amongst consumers, patients and healthcare providers. This toolkit provides Market Authorisation Holders (MAH) and SAHPRA...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of veterinary medicines. ...
The guideline is intended to provide guidance with regard to the legal system of measurement in South Africa. The guideline reflects the requirements as stipulated in the Legal Metrology Act, 2014 (Act 9 of 2014), and the Measuring Units and Measuring Standards Act, 2006 (Act...
This document is intended to provide clarity on guidelines and applications for the licensing of medical device establishments. 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...
This guideline is intended to provide guidance to applicants regarding applications for registering co-packaged medicines. It represents the South African Health Products Regulatory Authority (SAHPRA) current thinking on co-packaging of medicines. SAHPRA reserves the right to request any additional information to establish the safety,...