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  • Guideline on Application of Manufacturer’s, Import and Wholesaler’s . . .
    Guidance Document: Updated: Guideline on Application of Manufacturer’s, Import and Wholesaler’s Licenses for Registered Products (3rd Edition) March 2025: Garis Panduan Permohonan Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong Keluaran Berdaftar (Edisi 3) Mac 2025
  • GUIDELINE - npra. gov. my
    GUIDELINE APPLICATION OF MANUFACTURER’S, IMPORT AND WHOLESALER’S LICENSES FOR REGISTERED PRODUCTS 3RD EDITION | MARCH 2025 Ministry of Health Malaysia National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Profesor Diraja Ungku Aziz 46200 Petaling Jaya, Selangor +603-78835400 | https: www npra gov my
  • Guide to NPRA Product Registration in Malaysia - Emerhub
    Imported products must be registered with the NPRA before distributing them to Malaysia 3 Retailers: Must ensure products are NPRA registered and obtained through licensed distributors 4 Distributors: Companies handling the sale and storage and distribution of products must hold NPRA licenses Registration Process for NPRA Certification in
  • Guidelines for Compliance Licensing
    Guidance Document: Verification for Traditional Medicines (TM) Health Supplements (HS) Manufacturers, Second Edition, May 2025 21 May 2025 Hits: 520 Guideline on Application of Manufacturer’s, Import and Wholesaler’s Licenses for Registered Products (3rd Edition, March 2025) 27 March 2025 Hits: 32148
  • Generic Submission - National Pharmaceutical Regulatory Agency (NPRA)
    Online application forms are available for different product categories in the QUEST system This submission guide is arranged according to several parts in QUEST3+ online form Applicant shall follow and comply with all requirements in the online application forms as well as any supplementary documentation requested by the Authority, whichever
  • Application Forms - National Pharmaceutical Regulatory Agency (NPRA)
    National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia Malaysia Drug Control Authority Document Name PDF MS Word Updated; Template for Declaration of Worldwide Registration Status (WWRS) E15-Download 3 2023: Download 10 2024: Screening Checklist for Generics Application
  • GUIDELINE - National Pharmaceutical Regulatory Agency (NPRA)
    GUIDELINE APPLICATION OF MANUFACTURER’S, IMPORT AND WHOLESALER’S LICENSES FOR REGISTERED PRODUCTS 2ND EDITION | JULY 2023 Ministry of Health Malaysia National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Profesor Diraja Ungku Aziz 46200 Petaling Jaya, Selangor +603-78835400 | https: www npra gov my
  • Step 1 of 4: Pre-submission of Application (Preparation)
    1 4 2 8 Bioequivalence (BE) Study Report for Generic Products (according to ASEAN Guidelines) In general, for a second source application of a generic product (immediate release, oral solid dosage form), BE study report from the actual manufacturing site must be submitted during the submission of application for registration
  • Guideline on Application of Manufacturer’s, Import and . . . - NPRA
    Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia Phone: +603-7883 5400 Guideline on Application of Manufacturer’s, Import and Wholesaler’s Licenses for Registered Products
  • Frequently Asked Questions (FAQs) : Licensing
    The processing fee of an application for a Manufacturer’s Licence is RM1000 00 and RM500 00 for an Import Licence or a Wholesaler’s Licence The processing fee shall not be refundable Online banking account (Personal or Business) or credit card is required to conduct payment transactions via FPX (Financial Process Exchange)
  • Guideline on Application of Manufacturer’s, Import and Wholesaler’s . . .
    National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia Malaysia Drug Control Authority English (UK) Guideline on Application of Manufacturer’s, Import and Wholesaler’s Licenses for Registered Products (3rd Edition, March 2025) Emel Kadar pengguna: 5 5 Sila beri kadar Guidance Document: Updated: Guideline
  • Guidelines for Compliance Licensing - npra. gov. my
    National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia Malaysia Drug Control Authority Portal Rasmi Bahagian Regulatori Farmasi Negara Guideline on Application of Manufacturer’s, Import and Wholesaler’s Licenses for Registered Products 12 July 2023 Hits: 31820 Site Master File Third Edition 2014





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