Step 2 of 4 : Submission for New Product Registration

The following dossier shall be submitted by the applicant for the purpose of registering combination product:

 

Dossier Requirement for Drug Component

Dossier Requirement for Medical Device Component

Drug-Medical Device Combination Product

Refer to DRGD, Appendix 2: Requirements for Product Registration 

 

For product registration :

 

NCE

Biologics

Generic

 

Refer to Appendix 2: Ancillary Medical Device Dossier Requirement for Drug-Medical Device Combination Product

Medical Device-Drug Combination Product

Refer to Appendix 3: Ancillary Drug Dossier Requirement for Medical Device-Drug Combination Product

Refer to MDA/GD-04: Common Submission Dossier Template First Edition March 2014

 




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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