When did MCC change to SAHPRA?
February 2018
In February 2018 the Medicines Control Council (MCC) was replaced by the South African Health Products Regulatory Authority (SAHPRA).
Which of the following regulatory actions can SAHPRA take in response to a safety concern?
Regulatory actions that SAHPRA can take in response to a safety concern include: Distributing Dear Healthcare Professional Letters or publishing Medicine Safety Alerts in Medical Journals to inform healthcare professionals. Issuing of press releases to informing consumers.
Who is the CEO of SAHPRA?
Dr Boitumelo Semete-Makokotlela
08 Oct MEET THE SAHPRA CEO SAHPRA is pleased to announce the appointment of a new Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, who will commence with this role in January 2020. Dr Semete-Makokotlela holds a Ph.
What is the South African equivalent of the FDA?
SAHPRA
SAHPRA – South African Health Products Regulatory Authority.
Is SAHPRA a government?
SAHPRA is an entity of the National Department of Health, created by the South African Government to ensure that the health and well-being of human and animal health are at its core.
What is SAHPRA Licence?
The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) in South Africa to ensure the availability of medical devices that comply with an acceptable level of safety, quality and …
What are the three pillars that define the ethos of SAHPRA?
SAHPRA has three pillars to ensure that medicines, medical devices and IVDs meet the requisite standards to protect the health and well-being of South Africans:
- Safety.
- Efficacy.
- Quality.
How do I get a SAHPRA license?
Completed application forms with the following supporting documents:
- Licence application cover Letter.
- Proof of payment with the correct reference as per Annexure A – SAHPRA Fee Categorisation Guideline.
- Latest Inspection resolution if applicable.
- Existing Licence being renewed/amended if applicable.
Is SAHPRA independent?
Subsequently, SAHPRA was constituted as an independent entity that reports to the National Minister of Health through its Board.
What is the role of SAHPRA as regulatory body?
The South African Health Products Authority (SAHPRA) is the Regulatory Authority of South Africa, which is responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices, radiation emitting devices and …
How do I get a SAHPRA Licence?
What is the purpose of SAHPRA?
What are the legislative mandates of sahpra?
The legislative mandates of SAHPRA are derived from the Constitution; the National Health Act, 2003 (Act No. 61 of 2003); the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended (hereinafter referred to as “the Medicines Act”); and other relevant legislation, regulations and policies.
What does sahpra do for medical devices?
Medical Devices The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) in South Africa to ensure the availability of medical devices that comply with an acceptable level of safety, quality and performance.
What does sahpra mean when it says first commercial licence issued?
The South African Health Products Regulatory Authority (SAHPRA) notes with concern the statement made on Cape Talk Radio that the regulatory authority has issued the first commercial licence for the cultivation of cannabis for all purposes.
What are the requirements for a sahpra medical device establishment licence?
As part of the application for a SAHPRA medical device establishment licence a company must list all the medical devices that it manufactures, distributes, or wholesales. The application includes a declaration regarding the status of the quality management system in place in the company.