Section A Combination Products
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
Application shall be accompanied with fees as specified to Fifth Schedule of Medical Device Regulation 2012.
|
Medical Device-Drug Combination Product (RM) |
Drug-Medical Device Combination Product (RM) |
|
|
Application Fee |
Registration Fee |
Administration Fee |
|
750 |
5000 |
100 |
FEES IMPOSED BY CAB
Refer Circular Letter of Medical Device Authority No.2 Year 2014.