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: Posted By Seksyen Pelesenan & Pensijilan; 25 September 2026; Hits: 72528

Guideline on Application of Manufacturer’s License, Import License and Wholesaler’s License for Registered Products (5th Edition, September 2026)

User Rating: 4 / 5

Guidance Document	Updated
Guideline on Application of Manufacturer’s License, Import License and Wholesaler’s License for Registered Products (5^th Edition)	September 2026
Garis Panduan Permohonan Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong Keluaran Berdaftar (Edisi 5)	September 2026

: Posted By Seksyen Amalan Perkilangan Baik; 21 July 2026; Hits: 37253

Guidance Document Foreign GMP Inspection, 11th Edition

Document Name	Download	Updated
Guidance Document Foreign GMP Inspection, 11th Edition		June 2026

: Posted By Jauze; 16 January 2019; Hits: 48774

Template and Declaration Letter for API

User Rating: 4 / 5

Document Name	Download	Updated
Declaration Letter for an Approved API in New Product Registration Application		Dec-19
Declaration on GMP of API Intermediate		Aug-18
Declaration on Quality of Atypical API (Letter_AAPI_V1)		Oct-19
Template Cover Letter for DMF Submission		Dec-19
Facilitated Registration Pathway (FRP) Checklist for API Part		Aug-26

National Pharmaceutical Regulatory Agency (NPRA)

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

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