Regulations on Importing Veterinary Drugs

For importing veterinary drugs into Japan, the provisions for conventional medicinal products, quasi-drugs, medical devices and medical products for regenerative medicine are applied in the same way.  However, unlike pharmaceuticals, the Ministry of Agriculture, Forestry and Fisheries has jurisdiction over this topic.

1 Importation as a Business

In the case of importing veterinary medicinal products as a business:

  1. The importer is required to obtain a license from the Minister of Agriculture, Forestry and Fisheries for manufacturing and sales. 
  2. For those who manufacture veterinary medicinal products in a foreign country, certification and registration as a foreign manufacturer is required for each manufacturing site. 
  3. The business operator in Japan that manufactures label replacements will need to obtain a manufacturing license and registration.
  4. Approval and certification are required for each veterinary drug product imported.

2 Import other than business purposes

In principle, importation by person without a manufacturing and sales license is prohibited.  However, there are certain exceptions, such as for the purpose of testing and research.   In the case of importation based on such exceptions, import verification is required. 

In addition, import verification is not required in the case of:

  1. the owner of an animal other than the subject animal (dog/cat) may import No more than two boxes or two months’ supply of one pharmaceutical product as a portable product for use with the animal;
  2. a veterinarian or the operator of an animal care facility may import no more than two boxes or two months’ worth of each item of veterinary medicine as a portable product for his/her own use for the purpose of diagnosis, treatment or prevention of disease; and
  3. a veterinarian for his or her own medical treatment, where the animals to be used are other than the subject animals, and where the quantity of veterinary drugs to be imported is six boxes or less for each item

3 Prohibition of Importation

The import of illicit veterinary drugs is prohibited.

4 Prohibition of Advertising

Advertising for unapproved and uncertified drugs, medical devices, and regenerative medicine products is prohibited.


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