Variation Application For Pharmaceutical Products- Malaysian Variation Guideline (MVG)

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Variation application for pharmaceutical products shall be done according to the Malaysian Variation Guideline (MVG).

Reference: Pekeliling Berkenaan Pengemaskinian Garis Panduan Malaysia Variation Guideline For Pharmaceutical Products (2nd Edition, July 2022)

 

For unregulated drug substances, kindly note that only the following sections are required and will depend on the type of variation being applied. This is applicable until further notice: 

  1. General Information (Nomenclature, Structure, General Properties) 
  2. Manufacturer Details 
  3. Specification of API 
  4. Batch Analysis 
  5. Certificate of Analysis (COA) from API manufacturer 
  6. Certificate of Analysis (COA) from finished product manufacturer 
  7. Justification of Specification 
  8. Certificates of Suitability (CEP) and its related sections  
  9. Drug Master File (DMF) and its related sections 
  10. Certificate of GMP for API Manufacturer 
  11. Other Supporting Documents 

  

MODE OF SUBMISSION 

Applicant shall submit the variation application through the current online system. 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 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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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 03 February 2023, 10:55:11.
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