UMKU Pharmaceutical Industry Details

Parameter: All

Authority: Minister/Head of Agency

Requirements:

1. Specifically for domestically produced veterinary drugs:
   • Good Manufacturing Practices for Veterinary Drugs (CPOHB) certificate according to the scope of the registered veterinary drugs
   • Statement expressing the commitment to implement CPOHB and obtain the CPOHB certificate no later than 1 year after the first registration number for veterinary drugs is issued

   Timeframe: -

2. Must have a business permit as an importer and/or manufacturer of veterinary drugs

   Timeframe: -

3. Approval from the veterinary drug registration assessor (PPOH) and/or the veterinary drug commission (KOH) for the technical documents (dossier) of veterinary drugs

   Timeframe: -

4. Certificate of environmental safety from the Genetic Engineering Product Safety Commission, for veterinary drugs originating from genetically modified organisms (GMO)

   Timeframe: -

5. Certificate of quality testing results from the National Quality Testing and Certification Center for Veterinary Drugs (BBPMSOH)

   Timeframe: -

6. Specifically for imported veterinary drugs:
   • Certificate of Origin issued by the authorized agency in the country of origin
   • Certificate of Free Sale issued by the authorized agency in the country of origin
   • Good Manufacturing Practices (GMP) certificate or equivalent certificate issued by the authorized agency in the country of origin
   • GMO/Non-GMO Certificate for probiotic, enzyme, amino acid, and biological products issued by the competent authority in the country of origin
   • Registration Certificate issued by the competent authority in the country of origin
   • In case a Registration Certificate is not issued by the government of the country of origin, a Veterinary Health Certificate or equivalent document stating that, based on the regulations in that country, the product is not required to be registered, and the government of the country of origin oversees the quality, efficacy, and safety of the product, issued by the government of the country of origin

   Timeframe: -

7. Letter of Appointment from the principal

   Timeframe: -

8. Letter of compliance review for the application of Good Manufacturing Practices (On-site review) for veterinary drugs that are registered for the first time, have a new dosage form, and/or originate from a manufacturer/factory that has never supplied the dosage form to be registered.

   Timeframe: -

9. Specifically for contract veterinary drugs (toll manufacturing):
   • CPOHB certificate for the recipient contract manufacturer that is still valid according to the dosage form of the contracted veterinary drug
   • Contract agreement for toll manufacturing

   Timeframe: -

10. Specifically for licensed veterinary drugs:
    • Domestic veterinary drug manufacturer
    • License agreement between the licensor and licensee
    • Good Manufacturing Practices (GMP) certificate for the licensor of veterinary drugs that is still valid according to the dosage form of the licensed veterinary drug
    • CPOHB certificate for the licensee of veterinary drugs that is still valid according to the dosage form of the licensed veterinary drug

    Timeframe: -

Obligations