Malaysian Variation Guideline for Pharmaceutical Products (second edition, July 2022)

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This Malaysian Variation Guideline concerns the variation applications submitted by the PRH for pharmaceutical products for human use only. It is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a pharmaceutical product. 

 

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National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof 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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