A : Table of Contents

A table of contents for the filed application should be provided.

B : Safety Documentation
B1 : Pharmacology
B2 : Toxicology
B3 : Studies of Other Effects
B4 : User Safety
B5 : Environmental Risk Assessment (Environmental Safety)
B6 : Key Literature
C : Residue Documentation (Human Food Safety)(For a product intended for use in Food-Producing Animal Species)
C1 : Formulation Used in Residue Studies
C2 : Residue Studies
C3 : Analytical Method(s)

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


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