DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)13.2 LICENSE APPLICATION FORM1. The license application for registered products (Manufacturer‟s License, Import Licenseand Wholesaler‟s License) shall be submitted by filling Borang BPFK-413 Application forLicense for Registered Product.2. Application form must be submitted with the following supporting documents.a) Company‟s Organization Chartb) Location Map of Premisec) Layout Plan of Premised) List of Storage Equipmentse) Details of other products (Non-medicinal) stored at the same premisef) A copy of Business License (Local Authority) for business premise or store (if any)g) A copy of Applicant‟s/License Holder‟s Identity Cardh) A copy of Annual Retention Certificate and/or Type A License (This document isnecessary if products manufactured/ imported/ wholesale are Scheduled Poison Aproducts or any other products that require a Pharmacist)i) A copy of previous license (For renewal application)3. An application shall only be processed if it is complete and payment has beenapproved.4. The processing fee shall not be refundable. The processing fee of an application for aManufacturer‟s License is RM 1,000.00 and RM 500.00 for an Import License or aWholesaler‟s License.5. Each license is valid for one (1) year.13.3 ADDITIONAL LIST OF LICENSE FOR REGISTERED PRODUCTS1. Additional list of License are issued based on the application submitted when theproducts are newly registered, changing of manufacturer or importer or any registeredleft out products from the products list of Manufacturer‟s License and Import License.2. When submitting the application form for Additional List of License for RegisteredProducts the documents that shall be attached together are a copy of Manufacturer‟sNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 103