The SA Health Products Regulatory Authority (SAHPRA) last week gave emergency authorisation for the importation of the Dollvet FMD vaccine, bringing some relief for the country’s farming sector grappling with Foot-and-Mouth Disease (FMD).
SAHPRA said its Section 21 approval came with conditions, and that it was assessing an additional application for the same vaccine, reports the Sunday Tribune.
The highly contagious outbreak, which affects cloven-hoofed animals like cattle, pigs and goats, causing painful sores and severe production losses, prompted President Cyril Ramaphosa to declare a national disaster.
SAHPRA CEO Boitumelo Semete-Makokotlela said: “The health of our livestock is critical to South Africa’s food security, economic stability and the livelihoods of our farmers. By granting Section 21 authorisation … SAHPRA is ensuring that veterinarians and farmers have timely access to safe, effective and scientifically approved tools to protect animals against this devastating disease.”
Section 21 of the Medicines and Related Substances Act provides a mechanism for the controlled importation of medicines and vaccines not yet registered in South Africa, under strict regulatory oversight.
Distribution of the vaccine will be co-ordinated by the Department of Agriculture: Animal Health, which is responsible for implementing national disease control measures.