FEES FOR REGISTRATION OF COMBINATION PRODUCTS
Every application for registration shall be accompanied with a fee imposed by the respective agencies as specified in the table below.

Any payment made shall NOT be REFUNDABLE once the application has been submitted and payment confirmed.

Applications without the correct fees will not be processed.
FEES IMPOSED BY NPRA

Under the CDCR 1984, Regulation 8(3): The Authority may charge any applicant such costs as it may incur for the purpose of carrying out any evaluation or investigation prior to the registration of any product.


No.

Category of Product

* Processing Fees

Analysis Fees

Total Fees

Drug-Medical Device Combination Product

1.

Pharmaceutical

a.    New Drug Products

b.    Biologics

RM 1,000.00

Single active ingredient :

RM 3,000.00

RM 4,000.00

Two or more active ingredients :

RM 4,000.00

  RM 5,000.00

2.

Pharmaceutical

a.  Generic (Scheduled Poison)

b.  Generic (Non-Scheduled Poison)

RM 1,000.00

Single active ingredient :

RM 1,200.00

RM 2,200.00

Two or more active ingredients:

RM 2,000.00

  RM 3,000.00

FEES IMPOSED BY MDA

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

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Jumaat 19 Julai 2019, 16:49:18.
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