UMKU Pharmaceutical Industry Details

Parameter: All

Authority: Minister/Head of Agency

Requirements:

1. Approval for the Transfer of Veterinary Drug Registration Numbers:

   • Letter of registration number for veterinary drugs
   • Statement from the applicant as the owner of the registration number, willing to transfer the registration number
   • Statement from the recipient company of the registration number transfer, willing to accept the registration number transfer
   • Notary deed regarding the agreement for the transfer of registration numbers between the owner of the registration number and the recipient company of the registration number transfer
   • Certificate of quality testing results from the National Quality Testing and Certification Center for Veterinary Drugs (BBPMSOH) issued for veterinary drugs from the recipient company of the registration number transfer

2. Specifically for the transfer of registration numbers for domestic products:

   1. Veterinary drug master file (DMF)
   2. Statement from the recipient company of the registration number transfer that all veterinary drug master file documents and their production processes have not undergone any changes and still conform to the registered formulation

3. Specifically for the transfer of registration numbers for imported products:

   1. Statement from the principal company that it is no longer in cooperation with the owner company of the registration number, and the cooperation has been transferred to the recipient company of the registration number transfer
   2. Letter of appointment from the principal to the recipient company of the registration number transfer

4. Specifically for the transfer of registration numbers for imported products to domestic manufacturers:

   1. Veterinary drug master file (DMF)
   2. Statement from the recipient company of the registration number transfer that all veterinary drug master file documents and their production processes have not undergone any changes and still conform to the registered formulation. If there are changes in the manufacturing process, formulation, composition, and quality control, it must be registered as a new product
   3. Statement from the principal/manufacturer that it is no longer in cooperation with the owner company of the registration number, and the production of veterinary drugs has been transferred to the recipient company of the registration number transfer

Obligations