Veterinary Drugs Control Act Article 12

To apply for product registration and license to manufacture or import veterinary drugs, one shall submit documents (about ingredients, functionality, essential manufacturing process, assay, and relevant information or certificates) along with samples (of the label, package insert and drug) and fees (for the license and testing) to the central competent authority. One must not begin to manufacture or import the veterinary drug until the license is issued.Regulations for product registration, review process, license-related matters (the change, renewal, reissuance, replacement, annulation, and other items to comply with thereof), and rules to follow as referred to in the preceding paragraph shall be prescribed by the central competent authority.The central competent authority may cite Good Manufacturing Practice (GMP) for veterinary drugs as a criterion for the issuance or renewal of manufacture/import licenses. The Good Manufacturing Practice (GMP) for veterinary drugs is to be prescribed by the central competent authority.The review criteria and procedure for a made-for-export-only manufacture license may be simplified and made less onerous; however, the veterinary drug thus produced must not be sold domestically or used for other purposes.Before a new veterinary drug is approved for product registration , it shall be subject to safety and efficacy tests conducted by the central competent authority itself or an accredited agency delegated by the said authority; the applicant for product registration shall bear the cost of such tests; the testing methodology is to be prescribed by the central competent authority.