Directives
Second Source and Replacement Products
Written by Fatin Diyana Fauzi · 4 December 2019
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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.
2nd_source_and_replacement_products_effective_August_PDF.pdf