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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.

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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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