Licensing (Manufacturer, Importer and Wholesaler)

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According to the Controls of Drugs and Cosmetics Regulations 1984, any company that want to manufacture, import or wholesale any registered products need to have Manufacturer’s Licence, Import Licence or Wholesale Licnese. Licencing unit, Centre for Compliance and Licensing (CCL) involves in the activity of issuance of Licence.

Type of Licenses

Type of Licenses  Activity 
Manufacturer’s Licence 

Licensed Premises is allowed to: Manufacture registered products and to sell by wholesale or supply their products.

Import Licence

Licensed Premises is allowed to: Import and sell by wholesale or supply registered products.

Wholesaler’s Licence

Licensed Premises is allowed to: Sell by wholesale or supply registered products.

Note: For license application, please submit via online application through Quest3+. Borang BPFK-413: Application for Licence for Registered Products (Manufacturer’s Licence, Import Licence, and Wholesaler’s Licence) only applicable for government agencies.

Additional List of Licence for Registered Products

Additional list of Licence are issued based on the application submitted when the products are newly registered, changing of manufacturer or importer or any registered left out products from the products list of Manufacturer’s License and Import Licence. 

When submitting the application form for Additional List of Licence for Registered Products the documents that should be attached together are a copy of Manufacturer’s Licence/Import Licence, a copy of DCA Approval Letter/DCA Meeting Result. 

For company would like to apply for adding new registered products/left out registered products into the Manufacturer’s Licence/Import Licence, please use Borang Senarai Keluaran (Tambahan) Lesen Keluaran Berdaftar.

For application forms related to licensing, please visit Compliance and Licensing section at the Application Forms page.

For further enquiries, please visit Frequently Asked Questions (FAQs) : Licensing

 

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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  • Last Modified: Wednesday 12 December 2018, 16:48:53.
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