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.