Frequently Asked Question : Compliance & Licensing
FAQs : Licensing
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.
4) LAWS AND REGULATIONS
- Poison Act 1952 and Regulations (Act 366)
- Sale of Drugs Act 1952 (Act 368)
- Dangerous Drug Act 1952 and Regulations (Act 234)
- Control of Drugs and Cosmetics Regulations 1984
*Note: In addition to the above laws and regulations, Manufacturers are required to comply with the principles of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Meanwhile, Importers and Wholesalers are required to comply with the principles of Good Distribution Practice (GDP).
5) HOW TO APPLY?
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Online application can be made via https://www.npra.gov.my/index.php/industry
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An application will only be processed if it is complete and payment has been approved.
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Application form for government agencies is available from the National Pharmaceutical Regulatory Agency website on https://www.npra.gov.my/index.php/en/compliance-and-licensing-main-page.html
6) CAN A LICENCE APPLICATION BE REFUSED?
7) CAN A LICENCE BE REVOKED?
As defined under the Control of Drugs and Cosmetics Regulations 1984, Regulation 17:
The Director of Pharmaceutical Services may, at any time and without assigning any reason, revoke any licence issued under these Regulations and may amend the conditions to which such licence is subject to.
8) IF A COMPANY HAS A STORE(S) WHICH IS/ ARE LOCATED SEPARATELY FROM THE BUSINESS/ MANUFACTURING PREMISE, WHAT IS THE MAXIMUM NUMBER OF STORES ALLOWED IN A LICENCE?
The maximum number of stores allowed in a licence is three.
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:
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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.
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Online banking account (Personal or Business) or credit card is required to conduct payment transactions via FPX (Financial Process Exchange).
