Animal Drug Registration Permit (re-registration)
UMKU Pharmaceutical Industry Details
Parameter: All
Authority: Minister/Head of Agency
Requirements:
- Letter of registration number for veterinary drugs
Timeframe: -
- Statement from the company's leader that the re-registered veterinary drug has not undergone changes in composition, factory location, production process, shelf life, administration route, target animals, and/or packaging materials
Timeframe: -
- Certificate of quality testing results from the National Quality Testing and Certification Center for Veterinary Drugs (BBPMSOH)
Timeframe: -
- Specifically for domestically produced veterinary drugs: CPOHB (Good Manufacturing Practices for Veterinary Drugs) certificate according to the scope of the registered veterinary drugs
Timeframe: -
- Specifically for imported veterinary drugs: Letter of appointment from the principal
Timeframe: -
-
Specifically for licensed veterinary drugs:
- License agreement between the licensor and licensee
- Valid GMP (Good Manufacturing Practices) certificate for the licensor of veterinary drugs, in accordance with the dosage form of the licensed veterinary drug
- Valid CPOHB (Good Manufacturing Practices for Veterinary Drugs) certificate for the licensee of veterinary drugs, in accordance with the dosage form of the licensed veterinary drug
Timeframe: -
Obligations
Sector: Agriculture
Status: Available
Belongs to:
20223
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