Variation Application For Pharmaceutical Products

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Variation application for pharmaceutical products shall follow Malaysian Variation Guideline (MVG) as stated in the directive issued by the Director of Pharmaceutical Services under Regulation 29, CDCR 1984.

Reference: (2) dlm BPFK/PPP/07/25.)

Arahan Pengarah Kanan Perkhidmatan Farmasi Bil 3 Tahun 2013: Direktif untuk melaksanakan Malaysian Variation Guideline (MVG) (29 April 2013) 

If deemed necessary, NPRA reserves the right to request for additional supporting documents and variation approval letters from other regulatory bodies for all categories of product. 

The registration of a product shall be reviewed for suspension or cancellation if changes that fall under Major Variation (MaV) and Minor Variation Prior Approval (MiV-PA) are implemented without prior approval of the Authority.

For drug substance that are yet to be regulated by NPRA, application for variations and supporting documents related to drug substance at Appendix 12 are still applicable until further notice.

  

MODE OF SUBMISSION 

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

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