FAQ Vet - COH
- General/Regulatory
- Classification
- Change Of Product Registration Holder(COH)
- Change Of Site (COS)
- Variation
- Renewal
CHANGE OF PRODUCT REGISTRATION HOLDER(COH)
1.What is the procedure of Change of Holder?
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).
2.What is the fee for Change of Holder?
The fee is RM 1000 per product.
3.What are documents required for COH?
To refer Appendix 8 in Registration Guideline of Veterinary products (REGOVP).
4. Are original documents required for COH? Can photocopy documents be submitted?
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.
5. Who can submit the Change of Product Registration Holder application?
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.
6. Can the Resolution of Board of Directors be submitted without one or more of the Directors signatures?
All Board of Directors/Partners will have to sign and give their consent to the Change of Product Registration Holder.
7. What is the timeline for Change of Product Registration Holder application?
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.
8. Can the Change of Product Registration Holder application be submitted if product’s registration has less than 6 months before expiring?
The existing Product Registration Holder must first submit and obtain the product registration renewal approval before applying for the Change in Product Registration Holder.
9.Can variation process be done during a COH submission?
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.