Animal Drug Registration Permit (emergency use approval for animal drugs)
UMKU Pharmaceutical Industry Details
Parameter: All
Authority: Minister/Head of Agency
Requirements:
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Environmental safety certificate from the Genetic Engineering Product Safety Commission, for veterinary drugs originating from genetically modified organisms (GMO).
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CPOHB (Good Manufacturing Practices for Veterinary Drugs) certificate, according to the scope of the registered veterinary drugs.
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Domestic veterinary drug manufacturer
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Statement from the applicant, stating, among other things:
- The registered veterinary drugs are urgently needed to combat diseases that cause animal deaths in several regions where there is no adequate treatment alternative.
- Responsibility for the quality of veterinary drugs.
- Conducting field trials to ensure effectiveness and safety.
- Monitoring the side effects of veterinary drugs (MESOH).
- Reporting on the production and distribution of veterinary drugs during emergency use approval, as well as reporting the results of MESOH to the Director General of Livestock and Animal Health.
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Field trial proposal.
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Approval from the Head of the Center for Veterinary Medicinal Products (PPOH) and/or KOH (National Drug Commission) for the technical documents (dossier) of veterinary drugs and approval for points c and d.
Obligations
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