Second Source and Replacement Products

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Second Source and Replacement Products (Effective August 2019)

  • All second source and replacement New Drug Product (NDP) products will be evaluated at NDP Section.
  • Requirement & fee will follow NDP.
  • Timeline: 210 working days.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400



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