3 Nov 2016
Enquiry: What Approval Documents are Required to Apply for Selling Pet Drugs to China?
Pet drugs are regarded as veterinary drugs in China. Registration at the administrative approval office of the Ministry of Agriculture shall be required for import of veterinary drugs.
Applicants should submit the following information:
- Two original copies of the Application Form for the Registration of Veterinary Drugs;
- A document certifying that the manufacture and sale of the drug were approved by competent veterinary authority of the country or territory wherein the manufacturer is based (notarised and verified);
- GMP certificate issued by competent veterinary authority of the country or territory wherein the manufacturer is based (notarised and verified);
- Authorisation Letter from the exporter, ID document or legal presence registration document of the applicant (photocopy);
- Samples, inspection and test records, and test reports of three consecutive lots;
- Materials of relevant seed bacteria (viruses, or insects) and cells, and their supporting documents, in case of application for exporting biological veterinary products to China;
- Supporting documents required by the Ministry of Agriculture in accordance with categories of veterinary drugs to be imported.