Pretoria–The South African Health Products Regulatory Authority (SAHPRA) has announced that it has granted Section 21 authorisation for the importation of the Dollvet Foot and Mouth Disease (FMD) vaccine, with conditions, and is currently assessing an additional application for the same vaccine.
FMD is a highly contagious viral disease affecting cloven-hoofed animals such as cattle, pigs, sheep, and goats.
It causes fever and painful blister-like sores in the mouth, on the teats, and between the hooves.
While many animals recover, outbreaks can result in severe production losses, high mortality in young animals, and significant economic consequences for the agricultural sector.
Speaking on the authorisation, on Friday, 13 February 2026, Dr. Boitumelo Semete-Makokotlela, Chief Executive Officer of SAHPRA, 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 for the importation of FMD vaccines, SAHPRA is ensuring that veterinarians and farmers have timely access to safe, effective, and scientifically approved tools to protect animals against this highly contagious and 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.
This pathway enables SAHPRA to respond rapidly to urgent public and animal health outbreaks while maintaining rigorous standards of quality, safety, and efficacy.
Authorisations granted under this provision are temporary and subject to ongoing review.
All imported vaccines undergo strict regulatory controls and quality assurance processes.
Distribution will be coordinated by the Department of Agriculture: Animal Health, which is responsible for implementing national disease control measures.
South Africa has about 14 million cattle.
FMD spreads rapidly through direct contact with infected animals, contaminated equipment, vehicles, clothing, feed, and even via wildlife carriers.
Outbreaks can lead to movement restrictions, quarantines, trade limitations, and increased compliance costs for farmers.
Loss of South Africa’s FMD-free status can trigger immediate export bans on livestock and related products, affecting foreign revenue losses and market stability.
The Department of Agriculture has emphasised that FMD is a controlled disease and that vaccination must take place only within officially approved programmes.
Unregulated vaccination may mask infections, weaken surveillance systems, and delay the country’s ability to regain its FMD-free status under international standards set by the World Organisation for Animal Health (WOAH).
“Our collaboration with SAHPRA reflects the importance of partnerships in safeguarding animal health,” said Dr. Bothle Modisane, Chief Director for Animal Health at the National Department of Agriculture.
“The South Africans farming community can be assured that every vaccine authorised for use in the country undergoes careful evaluation for safety, efficacy, especially against locally circulating strains, and quality, and we are optimistic that the disease will be contained.”
SAHPRA stated that it remains committed to transparency and will continue to update stakeholders on developments related to veterinary vaccine import authorisations for FMD control.
