Change of holder shall be submitted online via Quest 3+. The requirement can be viewed in Appendix 8 in Registration Guideline of Veterinary products (REGOVP).

The fee is RM 1000 per product.

To refer Appendix 8 in Registration Guideline of Veterinary products (REGOVP).

All supporting documents shall be produced in ORIGINAL copies.

For documents that is required to be a Certified true copy (i.e Company/ Business Registration Certificate of proposed new Product Registration Holder) and documents that require to be notarized or require a statutory declaration from the Commisioner for Oaths (i.e Letter of Authorisation (LOA) issued by Product Owner, Latest document indicating details of director/s and shareholder/s of local Product Owner/existing Product Registration Holder) must bear the original stamp and signature of the signatories.

Only the existing Product Registration Holder may submit the application for the Change of Product Registration Holder. The application can be made through the online QUEST 3+ system.

All Board of Directors/Partners will have to sign and give their consent to the Change of Product Registration Holder.

 

Once NPRA deems the application is complete, the outcome of the change of PRH application shall be decided by the Drug Control Authority within forty five (45) working days.

No. PRH are required to submit for variation before the submission of Change of Holder.

It is the responsibility of PRH to ensure all the information relevant to change of holder i.e. Product owner should be inline with the Quest 3+ system.