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Registration for Medicinal Products
Application Forms
  • APPLICATION FORM PART 1 - ADMINISTRATIVE DATA & PRODUCT INFORMATION - 3RD EDITION (JULY 2020)
  • (PART II) SECTION 1 QUALITY REQUIREMENTS OF THE DRUG SUBSTANCE
  • PART II SECTION 2 QUALITY REQUIREMENTS OF THE DRUG PRODUCT
  • APPLICATION FORM FOR APPEAL OF REJECTED MEDICINAL PRODUCTS
Guidelines
  • GUIDE TO APPLICATION FOR REGISTRATION OF MEDICINAL PRODUCTS (3RD EDITION, DEC 2012)
Checklist
  • CHECKLIST FOR SUBMISSION OF PART 1 - Administrative Data & Product Information - 4th Edition (July 2020)
  • CHECKLIST FOR PART II SECTION 1 - Quality Requirements of drug substance
  • PART II SECTION 2 - Quality Requirements of drug product
  • CHECKLIST PART III (NON CLINICAL DOCUMENT)
  • CHECKLIST PART IV (CLINICAL DOCUMENT)​
Log Forms
  • Log for Application for Registration of Medicinal Products - 3rd Edition (July 2020)
  • Log for Submission of Updated Documents for Application for Registration of Medicinal Products - 2nd Ed (July 2020)
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Variations

Guidelines
  • GUIDELINE ON APPLICATION FOR VARIATION TO REGISTERED MEDICINAL PRODUCTS
  • ASEAN VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS
Variation Codes
Checklist for submission of documents for application for Variation to Registered Medicinal Products
Application Forms
  •  APPLICATION FORM FOR VARIATION TO REGISTERED MEDICINAL PRODUCTS, 4TH EDITION (JULY 2020)
  • APPLICATION FORM FOR MINOR VARIATION (MIV-N) TO REGISTERED MEDICINAL PRODUCTS, 1ST EDITION (JULY 2020)
Log Forms
  • MINOR VARIATION NOTIFICATION, 2ND EDITION (JULY 2020)
  • UPDATED DOCUMENTS, 1ST EDITION (JULY 2020)
  • VARIATION, 2ND EDITION (JULY 2020)

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Renewal
Guidelines
  • GUIDELINE ON APPLICATION FOR RENEWAL OF REGISTRATION OF MEDICINAL PRODUCTS 2ND EDITION (JULY 2020)
Application Form
  • APPLICATION FORM FOR RENEWAL OF REGISTRATION OF MEDICINAL PRODUCTS, 3RD EDITION (JULY 2020)
Log Form
  • LOG FOR APPLICATION FOR RENEWAL OF REGISTRATION OF MEDICINAL PRODUCTS, 2ND EDITION (JULY 2020)

Consignment Basis
Guideline
  • GUIDELINE FOR SUBMISSION OF APPLICATION TO IMPORT A REGISTERED MEDICINAL PRODUCT BY NON-PRODUCT LICENCE HOLDER (ON CONSIGNMENT BASIS)
Checklist
  • CHECKLIST FOR SUBMISSION OF APPLICATION TO IMPORT A REGISTERED MEDICINAL PRODUCT BY NON-PRODUCT LICENCE HOLDER (ON CONSIGNMENT BASIS)
Application Form
  • APPLICATION TO IMPORT A REGISTERED MEDICINAL PRODUCT BY NON-PRODUCT LICENCE HOLDER (ON CONSIGNMENT BASIS)
Log Forms

  • LOG FOR THE APPLICATION TO IMPORT A REGISTERED MEDICINAL PRODUCT BY NON-PRODUCT LICENCE HOLDER (ON CONSIGNMENT BASIS)
Import License and Wholesaler License

Guideline
  • GUIDELINE ON APPLICATION FOR AN IMPORT LICENSE AND WHOLESALERS LICENCSE FOR MEDICINAL PRODUCTS (2017)
Application Forms
  • APPLICATION FORM FOR IMPORT LICENCE AND WHOLESALER’S LICENCE FOR MEDICINAL PRODUCTS
  • FORM A -  APPLICATION FORM FOR POISONS LICENSE
  • FORM B -  APPLICATION FORM FOR POISONS LICENSE
  • APPLICATION FORM FOR AMENDMENT TO AN IMPORT LICENCE AND WHOLESALE DEALER’S LICENCE FOR MEDICINAL PRODUCTS