Borang mendapatkan lesen racun - Borang A

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Borang membaharui lesen racun - Borang B

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Application forms for Drug Registration:

• Part I: Administrative Data and Product Information
  (Form No: BDMCA/DPS/01)     updated on 18.02.2013 

• Part II: Section 1: Quality Requirements of the Drug Substance
  (Form No: BDMCA/DPS/02/A)     updated on 18.02.2013 

• Part II: Section 2: Quality Requirements of the Drug Product
  (Form No: BDMCA/DPS/02/B)     updated on 18.02.2013 
   

Application checklists for Drug Registration:

• Checklist for Submission of Application for Registration of Medicinal Products Part I Requirements (Administrative Data & Product Information)     updated on 18.02.2013 

• Checklist on Documents Submitted for Part II – Section 1: Quality Requirements for Drug Substance

• Checklist on Documents Submitted for Part II – Section 2: Quality Requirements for Drug Product

• Checklist for Submission of Application for Registration of Medicinal Products Part III Requirements (Non-Clinical Document)

• Checklist for Submission of Application for Registration of Medicinal Products Part IV Requirements (Clinical Document)
   

Application form for Appeal for Registration of Rejected Medicinal Products
(Form No: BDMCA/DPS/Appeal/01)     updated on 18.02.2013 

Application form for Variations to a Registered Medicinal Product
(Form No: BDMCA/DPS/Vartn/02)     updated on 18.02.2013 

Application Form for Renewal of Registration for Medicinal Product  
  updated on 18.02.2013 

Application Form for an Import Permit of a Medicinal Product on Consignment Basis

Checklist for Submission of Application for an Import Permit of a Medicinal Product on Consignment Basis

Application Form for a Licence to Manufacture or Assemble Medicinal Products

Application Form to Amend Manufacturing Licence of Medicinal Products