Guideline Archives - Page 4 of 16

20 Nov Guideline for the Sealing and Unsealing of Hazardous Substances

Posted at 09:03h in

This guideline intends to narrate the critical framework of sealing and unsealing hazardous substances. It stipulates all enforcement actions necessary, according to the Hazardous Substance Act, 15 of 1973 with respect to Grouped Hazardous Substances, related regulations and prescribed licence conditions, that may be imposed...

16 Jul Guideline on Co-Applicancy

Posted at 12:01h in

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...

24 Apr GWP Guideline for the Importers and Distributors of Scheduled Substances

Posted at 11:19h in

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...

16 Jan Guidelines For Users of Electronic Therapeutic Devices Emitting Ionizing Radiation

Posted at 13:55h in

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)....

16 Jan Guideline for Import Applications of Electronic Devices Emitting Ionizing Radiation

Posted at 13:51h in

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....

12 Oct Clinical Trials Committee and Submission Dates for 2024

Posted at 15:38h in

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. ...

03 Oct Medicines Online Directory Toolkit

Posted at 10:47h in

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...

29 Jun General Information Guideline for Registration of Veterinary Medicines

Posted at 15:25h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of veterinary medicines. ...

04 Apr International Metric System (SI)

Posted at 09:44h in

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...

20 Feb Guideline on Co-packaging of Medicines

Posted at 10:08h in

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,...

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