UMKU Pharmaceutical Industry Details

Parameter: All

Authority: Minister/Head of Agency

Requirements:

1. Environmental safety certificate from the Genetic Engineering Product Safety Commission, for veterinary drugs originating from genetically modified organisms (GMO).

2. CPOHB (Good Manufacturing Practices for Veterinary Drugs) certificate, according to the scope of the registered veterinary drugs.

3. Domestic veterinary drug manufacturer

4. 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.

5. Field trial proposal.

6. 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