Variation Application For Biological Products

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16.1.3 VARIATION APPLICATION FOR BIOLOGICAL PRODUCTS

Variation application for biologics shall be done according to the Malaysian Variation Guidelines for Biologics (MVGB).

Reference: Directive No. 2, 2017. BPFK/PPP/07/25(7)Jld.1: Direktif Untuk Melaksanakan Malaysian Variation Guideline for Biologics (MVGB) (15 February 2017) 

 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.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor 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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