Generic Medicine

A generic product is a product that is essentially similar to a currently registered product in Malaysia. However, the term generic is not applicable to Biologics.

 Scheduled Poison
 (Known as Controlled Medicine/ Controlled Poison) Products containing poisons as listed in the First Schedule under Poisons Act 1952.

 Non-scheduled Poison
(Known as Non-Poison or “Over-the-Counter”, OTC) Products containing active ingredients which are not listed in the First Schedule under Poisons Act 1952; and is excluding active ingredient which is categorized under health supplements or natural products or cosmetics.

Recent Updates, Directives & Circulars


  • Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Generic Medicine
  • Directives & Circulars Related to Generic Medicine

Product Registration Process

Step I : Preparation

Product classification, Token Configuration, Payment Mode, Patent and Data Exclusivity status and Ensure key documents availability.

Pre-submission of Application (Preparation)

Step I : Preparation

Step 2 : Submission

Key-in, upload documents and submit your application (Part I, Part II, Part III & Part IV)

Product Validation, Part I, Part II, Part III & Part IV

Step 2 : Submission

Step 3 : Regulatory Outcome

Evaluation of Application & Drug Control Authority (DCA) decision.

Evaluation of Application & Drug Control Authority (DCA) decision.

Step 3 : Regulatory Outcome

Step 4 : Post-registration Process

Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities

Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities

Step 4 : Post-registration Process

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: Friday 14 December 2018, 08:46:08.
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