16.1.3 VARIATION APPLICATION FOR BIOLOGICAL PRODUCTS

Variation application for biologics shall follow the Malaysian Variation Guidelines for Biologics (MVGB) as stated in the directive issued by Director of Pharmaceutical Services under Regulation 29, CDCR 1984; Directive No. 2 Year 2017. Ref: BPFK/PPP/07/25(7)Jld.1: Direktif Untuk Melaksanakan Malaysian Variation Guideline For Biologics (MVGB)

The MVGB will serve as a main document for all variation applications.  The MVG will serve as a secondary document for all administrative changes.  If there are variations that are not covered in both MVGB and MVG, the PRH should determine the classification of change based on a change-specific risk assessment using the principles and examples that have been set out in the MVGB.  Please refer to section 3.0 (General Considerations) of the MVGB for further details.

 All applications submitted either via the QUEST3+ system or manually shall be accompanied by a cover letter, of which the content of the cover letter shall be in accordance to 4.1.2 and 4.1.3 of the MVGB.