Registration Of Product For Export Only (FEO)

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1. Refers to locally manufactured products for exporting purpose only and not marketed locally. This does not apply to imported products meant to be packed/repacked locally and to be re-export (the application falls under Regulation 7(2)(b), Control of Drugs and Cosmetic Regulations 1984. A separate application form may be obtained from the NPRA website).

2. Applications for registration of FEO products are only accepted in the following condition(s) and to be supported with evidence issued by the competent Authority of the importing countries (self-declaration is not accepted):

  • Countries which do not impose specific regulatory requirements as Malaysia (e.g. formulation with banned/ prohibited ingredients, zone IVB stability study, bioavailability/ bioequivalence study, API evaluation etc.); OR
  • Countries which have different requirements such as different formulation (e.g. colour or strength of ingredients), shape or manufacturing process, etc. as compared to a registered product; OR
  • Difference in classification category of the products (e.g. as food in the importing country) for health supplements and traditional products.

3. Applicant may apply for a Certificate of Pharmaceutical Product (CPP) for the registered FEO products.

4. For a registered product intended for exportation as well as to be sold in Malaysia:

  • New application for registration for export only will NOT be required if there is no change in the formulation and appearance of the registered product. 
  • Applicant may apply a CPP for the registered product and together with an explanation/ declaration letter of any difference(s) to the importing country (e.g. a product exported with a different product name).

5. For a registered product, now intended to be for export only and no longer for sale in Malaysia: 

  • Application for registration as a FEO product is required. 
  • The existing registration number (i.e. MAL number) will remain the same but with the addition of the administrative code E (For Export Only)

6. Applications for registration of FEO products are processed based on abridged evaluation. However, the additional following requirements must be filled for pharmaceutical products (not applicable to health supplements and traditional products):

  • Certificate of Analysis (COA) of finished product for at least 1 pilot batch; AND 
  • Minimum 6 months stability data (real time and accelerated stability study) for at least 1 pilot batch.

7. Application is via online submission in QUEST system.

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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