13 Feb SAHPRA Quick-Tracks Entry to Essential Foot and Mouth Illness Vaccines to Defend South Africa’s Livestock
Pretoria, 13 February 2026 –The South African Well being Merchandise Regulatory Authority (SAHPRA) confirms that it has granted Part 21 authorisation for the importation of the Dollvet Foot and Mouth Illness (FMD) vaccine with situations and is at the moment assessing a further utility for a similar vaccine.
Foot and Mouth Illness is a extremely contagious viral illness affecting cloven-hoofed animals similar to cattle, pigs, sheep, and goats. It causes fever and painful blister-like sores within the mouth, on the teats, and between the hooves. Whereas many animals get better, outbreaks may end up in extreme manufacturing losses, excessive mortality in younger animals, and important financial penalties for the agricultural sector.
Talking on the authorisation, Dr Boitumelo Semete-Makokotlela, Chief Government Officer of SAHPRA, mentioned:
“The well being of our livestock is vital to South Africa’s meals safety, financial stability, and the livelihoods of our farmers. By granting Part 21 authorisation for the importation of FMD vaccines, SAHPRA is making certain that veterinarians and farmers have well timed entry to protected, efficient, and scientifically accredited instruments to guard animals towards this extremely contagious and devastating illness”.
Part 21 of the Medicines and Associated Substances Act offers a mechanism for the managed importation of medicines and vaccines not but registered in South Africa, underneath strict regulatory oversight. This pathway allows SAHPRA to reply quickly to pressing public and animal well being outbreaks whereas sustaining rigorous requirements of high quality, security, and efficacy. Authorisations granted underneath this provision are non permanent and topic to ongoing evaluate.
All imported vaccines bear strict regulatory controls and high quality assurance processes. Distribution can be coordinated by the Division of Agriculture: Animal Well being, which is answerable for implementing nationwide illness management measures.
FMD spreads quickly by way of direct contact with contaminated animals, contaminated tools, autos, clothes, feed, and even through wildlife carriers. Outbreaks can result in motion restrictions, quarantines, commerce limitations, and elevated compliance prices for farmers. Lack of South Africa’s FMD-free standing can set off quick export bans on livestock and associated merchandise, affecting international income losses and market stability.
The Division of Agriculture has emphasised that FMD is a managed illness and that vaccination should happen solely inside formally accredited programmes. Unregulated vaccination could masks infections, weaken surveillance techniques, and delay the nation’s potential to regain its FMD-free standing underneath worldwide requirements set by the World Organisation for Animal Well being (WOAH).
“Our collaboration with SAHPRA displays the significance of partnerships in safeguarding animal well being. The South Africans farming neighborhood might be assured that each vaccine authorised to be used within the nation undergoes cautious analysis for security, efficacy, particularly towards domestically circulating strains and high quality and we’re optimistic that the illness can be contained” mentioned Dr Bothle Modisane, Chief Director for Animal Well being on the Nationwide Division of Agriculture.
SAHPRA stays dedicated to transparency and can proceed to replace stakeholders on developments associated to veterinary vaccine import authorisations for FMD management.
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