FAQs : GMP Inspection
| Document Name | Download | Updated |
|---|---|---|
| Soalan-soalan lazim berkenaan pemeriksaan APB dan AEB oleh NPRA semasa pandemik COVID-19 | DOWNLOAD | Aug 2021 |
| Frequently Asked Questions on GMP and GDP Inspections By NPRA during COVID-19 Pandemic | DOWNLOAD | Aug 2021 |
| Frequently Asked Questions (FAQs) : Good Manufacturing Practice (GMP) Inspection | DOWNLOAD | Mar 2026 |
| Frequently Asked Questions (FAQs) : Foreign Good Manufacturing Practice (GMP) Inspection | DOWNLOAD | Dec 2025 |
1) WHO SHOULD APPLY?
As defined under the Control of Drugs and Cosmetics Regulations 1984, Regulation 12(1):
- Manufacturer’s Licence / Lesen Pengilang
Manufacturers are required to apply for a Manufacturer’s Licence in order to manufacture registered products in their premises and to sell by wholesale or supply the registered products.
- Import Licence / Lesen Mengimport
Importers are required to apply for an Import Licence in order to import and sell by wholesale or supply registered products from their premises.
- Wholesaler’s Licence / Lesen Pemborong
Wholesalers are required to apply for a Wholesaler’s Licence in order to sell by wholesale or supply registered products from their premises.
2) WHAT IS A REGISTERED PRODUCT?
A registered product is a drug that is approved by the Drug Control Authority (DCA) for sale/use in Malaysia. This drug has been evaluated and tested for its efficacy and safety. Every registered product is given a registration number, which must be printed on its label or package. All product registration numbers start with ‘MAL’, for example MAL12345678A.
3) WHY SHOULD YOU APPLY FOR A LICENCE?
As defined under the Control of Drugs and Cosmetics Regulations 1984, Regulation 7(1):
- ….., no person shall manufacture, sell, supply, import, possess or administer any product unless -
(a) the product is a registered product; and
(b) the person holds the appropriate licence required and issued under these Regulations.
6) CAN A LICENCE APPLICATION BE REFUSED?
As defined under the Control of Drugs and Cosmetics Regulations 1984, Regulation 14:
The Director of Pharmaceutical Services may, if he thinks fit and without assigning any reason, refuse any application for a licence.
9) CAN THE STORES BE IN A DIFFERENT STATE THAN THE BUSINESS/MANUFACTURING PREMISE?
No. All the stores must be in the same state as the business/ manufacturing premise. Exception is only for Selangor and Wilayah Persekutuan Kuala Lumpur. For example, if the business/ manufacturing premise is located in Selangor while the store is in Wilayah Persekutuan Kuala Lumpur, it is permissible.
10) HOW MUCH IS THE PROCESSING FEE?
As defined under the Control of Drugs and Cosmetics Regulations 1984, Regulation 13:
- The processing fee of an application for a Manufacturer’s Licence is RM1000.00 and RM500.00 for an Import Licence or a Wholesaler’s Licence.
- The processing fee shall not be refundable.
- Online banking account (Personal or Business) or credit card is required to conduct payment transactions via FPX (Financial Process Exchange).
11) HOW LONG IS THE LICENCE VALID FOR?
Manufacturer’s Licence/ Import Licence/ Wholesaler’s Licence is valid for one (1) year starting from 1 January to 31 December of the same year.