Animals

1.1.1. Diagnostic and screening tests for controlled and notifiable animal diseases.

Requirements according to the Animal Diseases Act (Act 35 of 1984), R527, Regulation 12B (Registration for diagnostic testing for controlled and notifiable animal diseases) of the Department of Agriculture, Land Reform, and Rural Development (DALRRD):

  • Get DALRRD approval for veterinary laboratories performing diagnostic or screening tests for controlled and notifiable animal diseases. Test results must be reported to the Director
    • Certificate is valid for 2 years
  • Specific pathway for the importation of new diagnostic test kit or reagents – register facility and complete a specific form. Apply for a veterinary import permit as well

 

1.1.2. Activities with biological products for animals

This section deals with the following:

  • Any investigation, experiment, or research with any vaccine, serum, toxin, anti-toxin, antigen, or other biological product which consists or originates wholly or partially of, or from, any micro-organism, or of or from the glands, organs, fluids, or any other part, of an animal or parasite (excluding any substance that is controlled under the Medicines and Related Substances Control Act (Act 101 of 1965))
  • Manufacturing or evaluation of a product or remedy used for or intended to be used at or for the testing, diagnosis, prevention, treatment, or cure of any animal disease or parasite, or for the maintenance or improvement of the health, growth, production, or working capacity of an animal, use any vaccine, serum, toxin, anti-toxin, antigen or other biological product
  • For the purposes of any investigation, experiment, or research referred to:
    • Infect or contaminate any animal or any other thing with any animal disease or parasite
    • Introduce into or collect in the Republic, or have in their possession, or remove or transport from the place where it is normally found or kept, any controlled animal or thing, or any protozoon, bacterium, virus, fungus, parasite, other organism or agent which can spread any animal disease or parasite

Requirements according to Animal Diseases Act (Act 35 of 1984) Section 20:

  • Apply for a permit to:
    • Conduct any investigation, experiment, or research with animals or other listed substances
    • Manufacture or evaluate any product or remedy for testing, diagnosing, preventing, or curing any animal disease or parasite
    • Infect or contaminate any animal with a disease or parasite, introduce or transport any animal or thing that can spread animal disease or parasite
  • Apply for a recommendation report or certificate of compliance for BSL2, BSL3, Animal quarantine (BSL3), Biobank, or vector-protected facilities (Procedure manual available)
  • Each research project must apply for a separate Section 20 permit. Risk assessment to determine suitable biosafety level
    • Section 20 permit has a maximum validity of 3 years; after that, researchers must apply for an extension and/or amendment

 

1.1.3. Import or export pathology specimens and raw materials (e.g., pathogenic bacteria) for laboratory or pharmaceutical use

Requirements according to Animal Diseases Act (Act 35 of 1984) Section 20:

  • Apply for an import or export permit after the Section 20 permit has been issued
    • Include a copy of the Section 20 permit and data or specification sheets to import the product or culture
  • Locally produced Bovine Serum Albumin (BSA) and Foetal Bovine Serum (FBS): No permit is required if collected from carcasses in an abattoir inspected and passed as fit for human consumption. A certificate of origin should be available to confirm
  • Local production of monoclonal antibodies: Section 20 permit is required, and the facility may be inspected

 

1.1.4. Animals used for scientific purposes

Animal Ethics Committees should ensure that all animal care and use within the institution comply with this standard and will inspect animal housing and laboratory areas.

Requirements according to the South African National Standard (SANS) 10386:2021: The care and use of animals for scientific purposes

  • Apply for a permit to import animals and obtain veterinary health certificates from the DALRRD, the Chief Directorate of Veterinary Services and Livestock Improvement, and the Department of Animal Health
  • Crates for transporting all domestic and wild animals by air shall comply with the International Air Transport Association (IATA) Live Animal Regulations for air transport and the requirements specified by the relevant provincial nature conservation authority

 

Additional Information:

Marna Laing: Control Veterinary Technologist; Sub-Directorate: Epidemiology; Directorate: Animal Health; Department of Agriculture, Land Reform and Rural Development. 

Tel: 012 319 7442 | E-mail: [email protected].

Import and export permit applications submitted to: [email protected]

1.2.1. Research with animals

Requirements according to the Veterinary and Para-Veterinary Professions Act (Act 19 of 1982) as amended: Rules relating to the practicing of veterinary professions. Rule 32: Animal Research Facilities:

  • Register Animal Research Facilities with the South African Veterinary Council (SAVC)
    • Facilities will be inspected to ensure compliance with the minimum standards for facilities and that veterinary services are rendered at the required standards
    • A compliance certificate is issued once compliance with minimum standards is met
    • Facilities are inspected on a six-year cycle

 

1.2.2. Unregistered persons who perform any veterinary procedures with animals

Requirements according to the Veterinary and Para-Veterinary Professions Act (Act 19 of 1982):

  • Apply to the SAVC for authorisation of unregistered persons to render the procedures, functions, or services of the profession of a veterinarian or para-veterinary professional

 

Additional Information:

Import, manufacture, produce, or sell stock remedies or vaccines for use with domestic animals, livestock, poultry, fish, or wild animals to:

  • Prevent, treat, and cure unhealthy conditions
  • Maintain, grow, produce, and improve their health

Requirements according to the Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies Act (Act 36 of 1947):

  • Apply for registration of stock remedies, veterinary biologicals, and vaccines
    • You can only apply for registration if your company is registered in South Africa, or you are a legal body registered in South Africa

 

Additional Information: