Imported animal vaccine must be registered

About applying for a permit to import animal vaccines

You may only import, distribute or sell vaccines for use in animals in South Africa once they have been registered in terms of the Fertilizers, Farms Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

If you want to import a registered vaccine for use in animals, you must also obtain a veterinary import permit from the Directorate Animal Health. This import permit is valid for a limited period and for one consignment only. There are veterinary import protocols in place. As the health requirements change often, please contact the Directorate Animal Health (Tel 012 319 7507/7684/7700/7673/7456, Fax 012 329 6892) to obtain the latest requirements.

If you want to import an unregistered vaccine for a trial in South Africa, you need two permits. One permit is from the Registrar of Act 36 of 1947 and the other from the Directorate Animal Health. The application for the permit from the Registrar of Act 36 of 1947 must be accompanied by the complete proposed trial protocol.

The Directorate Animal Health issues an import permit only once they receive a copy of the permit issued by the Registrar of Act 36 of 1947. A vaccine imported for a trial may not be sold. In an emergency situation where an outbreak of a disease occurs and no registered vaccine is available in the country, it may be a necessary to use an unregistered vaccine. Then you, as a prospective importer, must apply to the Medicines Control Council for a Section 21 exemption in terms of the Medicines and Related Substances Control Act (Act 101 of 1965, as amended by Act 90 of 1997).

You also need, from the Directorate Animal Health, an import permit for the vaccine to enter the country. They issue this import permit only once you have obtained approval from the Medicines Control Council and submitted proof to them. In this case, the unregistered vaccine may be sold for a limited period until registration has been obtained.

What you should do

• You must first obtain registration or permission from the Registrar of Act 36 of 1947, or exemption in terms of Section 21 of Act 101 of 1965, to import the animal vaccine.
• When you receive the import permit from the Registrar of Act 36 of 1947, or exemption in terms of Section 21 of Act 101 of 1965, send a copy of it with your application for a veterinary import permit to the Directorate Animal Health.
• If the vaccine is already registered for use in South Africa in terms of Act 36 of 1947, you need only one import permit, from the Directorate Animal Health. Send a copy of the registration in terms of Act 36 of 1947 with your application.
• Complete the application form Application for a permit to import vaccines into the Republic of South Africa application. Contact the Directorate Animal Health if you are not sure which form to complete.  
• The state veterinarian at the Directorate Animal Health will contact you if further information is required and will do a risk assessment to consider your application.
• You must pay R120 for the permit.
• Deposit the permit fee into the Department’s bank account:
  Name of bank: Standard Bank of South Africa
  Name of account holder: National Department of Agriculture
  Account No: 011219556 International Band
  Branch: 010845
  IB brand 0001982 Centre Code
  Swift Code: SBZA-ZAJJ
  Name of the branch: Arcadia
  Important notice: Reference must be the importer’s name and surname
• You may also pay by cheque made payable to the Director-General: Department of Agriculture, Forestry and Fisheries.
• Payments can also be made at the offices of the Department of Agriculture, Forestry and Fisheries.
  Send the completed form and proof of payment to:
  The Director: Animal Health
  Import Export Policy Unit
  Private Bag X138
  Pretoria
  0001
  South Africa
  or Fax to 012 329 8292
• Please state on the application form whether the permit will be collected or mailed to you.
• Following receipt of the completed application form and proof of payment, a Veterinary Import Permit will be issued and sent directly to you.
• You are responsible for bank charges as well as the Foreign Bank charges; the Department will not issue a permit if the full fee of R120 is not received.
  
• In cases where you are applying on behalf of someone else, please make sure that you pay in the name of that person or company’s name.
  
  Note: No application will be processed without proof of payment. Proof of the deposit must be faxed to: 012 329 8292 for attention: Ina Labuschagne.

How long does it take

Once the state veterinarian at the National office has approved the importation, it takes three to five working days to process the application and issue the veterinary import permit.

How much does it cost

R120 for veterinary import permit

Forms to complete

(Forms are provided in PDF format. To open PDF documents, you need to have Adobe Acrobat Reader 4 or higher installed on your computer.)

• Application for a permit to import vaccines into the Republic of South Africa IMP.VAC00

Who to contact

Contact list