Private Import Support of Unapproved Veterinary Medicines, Veterinary Medical Devices, and Veterinary In Vitro Diagnostic Medicines
Veterinarians for their own medical practice, animal owners for the purpose of using on their own animals, and companies for research purposes are permitted to import unapproved veterinary medicines into Japan.
However, animal owners are not allowed to import veterinary medicines (such as regenerative medicine products) or vaccines for use on their own animals. Target animals, as defined in Article 24 of the Veterinary Medicines Control Regulation, include cattle, horses, pigs, chickens, quails, bees, and aquatic animals cultivated for food.
Furthermore, when owners of animals other than target animals such as dogs and cats individually import veterinary medicines that fall under the category of prescription medicines like heartworm preventives, a copy of the prescription or instruction issued by a veterinarian is required. AHRMS, Inc. provides assistance (private import) for the procedures of individually importing “unapproved” veterinary medicines and medical devices into Japan. Please contact us through the form below.
However, if the purpose of continuous import is to sell the products in Japan, as indicated under “Importing Veterinary Medicines for Business Purposes,” company’s business licenses and marketing authorization for each item are required. Please also refer to the Ministry of Agriculture, Forestry and Fisheries.
Importing Veterinary Medicines for Business Purposes
When a business entity with a manufacturing and sales permit or manufacturing permit under the Act on Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices (Pharmaceutical and Medical Device Act) imports veterinary medicines for manufacturing and sales, they must obtain a manufacturing and sales approval certificate, manufacturing and sales certification, or manufacturing and sales notification for the items to be imported. Each time they go through customs, they must present their business permit and the manufacturing and sales approval certificate for the imported items to the customs office to complete the customs procedures. For selling veterinary medicines as a business, a manufacturing and sales permit and manufacturing and sales approval for each item are required.