The South African Health Products Regulatory Authority (SAHPRA) says it has developed contingency plans to ensure that its essential services are not disrupted during the ongoing protest action by the employees of the Department of Health.
SAHPRA, which was established in February 2018 to replace the Medicines Control Council (MCC) as South Africa’s regulatory authority, continues with its work to ensure that health products available to the public are safe, effective and of good quality.
As the authority transitions from the MCC to SAHPRA, it continues to be housed with the department employees in the Civitas building in Pretoria.
Since April 2018, the department employees working in the Civitas building have embarked on protest action because of concerns about working conditions in the building.
“This has indirectly affected the activities of SAHPRA staff and the overall functionality of the regulatory authority. At present the delivery of paper documents to the SAHPRA offices is a challenge.
“The Board of SAHPRA shares the concerns of all parties about the Civitas building and supports the department’s efforts to address this problem. However, as the health product regulator, SAHPRA has a mandate to ensure the safety, quality and efficacy of medicines available in South Africa. Ensuring ongoing provision of all these services may be lifesaving,” said the regulatory authority.
Part of SAHPRA’s mandate is to issue permits, allowing individual seriously ill patients suffering from life-threatening conditions to have access in emergencies to currently unregistered medicines.
Special permits are also necessary to allow hospitals to maintain supplies of unregistered medicines required for emergency treatment of critically ill patients.
Another aspect of SAHPRA’s work, required around the clock, is the ability to rapidly respond to safety signals relating to health products that are available either legally or illegally to the public.
As attempts to resolve the situation at the Civitas offices continue, SAHPRA said it will evaluate the situation and offer continued guidance to stakeholders.
“In the medium term, SAHPRA as a Section 3A public entity, will move into new premises appropriate for the efficient functioning of the authority with state-of-the-art IT systems tailored to the needs of a regulator, and with user friendly access for the public, industry and its stakeholders,” said SAHPRA.
The authority encouraged the public and industry to contact SAHPRA in an emergency and with legitimate concerns through the following contacts:
- Director for Operations and Administration, Estelle Taute - 0795287755 for submissions;
- Acting Director, Tohlang Sehloho – 0823020222;
- Manager Section 21 Orthodox medicines; Shyamli Munbodh – 0721344546;
- Manager Pharmacovigilance, Florah Matlala – 0833873358;
- Manager Biological medicines, Khamusi Mutoti – 0713022135;
- Acting Director S21 Veterinary medicines Alice Sigobodhla – 0743791178
- Section 21 Orthodox medicines Adelaide Molatoli - 0637718906. – SAnews.gov.za