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 6 in Registration Guideline of Veterinary products (REGOVP).

2.What is the fee for Change of Holder?
3.What are documents required for COH?
4. Are original documents required for COH? Can photocopy documents be submitted?
5. Who can submit the Change of Product Registration Holder application?
6. Can the Resolution of Board of Directors be submitted without one or more of the Directors signatures?
7. What is the timeline for Change of Product Registration Holder application?
8. Can the Change of Product Registration Holder application be submitted if product’s registration has less than 6 months before expiring?
9.Can variation process be done during a COH submission?

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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  • Last Modified: Wednesday 21 August 2019, 09:55:47.
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