Animal Drug Registration Permit (approval for changing the registration number of animal drugs)
UMKU Pharmaceutical Industry Details
Parameter: All
Authority: Minister/Head of Agency
Requirements:
-
Change in composition, factory location, production process, shelf life, administration route, target animals, and/or packaging materials
- Approval from the Head of the Center for Veterinary Medicinal Products (PPOH) for technical documents (dossier) of veterinary drugs
- Letter of registration number for veterinary drugs
- Certificate of quality testing results from the National Quality Testing and Certification Center for Veterinary Drugs (BBPMSOH)
-
Changes in indications and/or withdrawal times of the drug
- Approval from the Head of the Center for Veterinary Medicinal Products (PPOH) for technical documents (dossier) of veterinary drugs
- Letter of registration number for veterinary drugs
-
Changes in product name, factory name, container/packaging size, and/or packaging volume
- Approval for technical documents (dossier) of veterinary drugs
- Letter of registration number for veterinary drugs
-
Changes in label/label design
- Letter of registration number for veterinary drugs
- Justification for the label/label design changes
Obligations
Sector: Agriculture
Status: Available
Belongs to:
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