Variation Application For Pharmaceutical Products

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Variation application for pharmaceutical products shall be done according to the Malaysian Variation Guideline (MVG).

Reference: Bil. (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)

For unregulated drug substance: Appendix 30: Conditions and Supporting Documents Required for an Application of Variation are still applicable for application for variations and supporting documents related to drug substance 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 (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

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Monday 29 November 2021, 16:44:41.
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