Ministry of Health - Importation of Medicines

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Registration for Medicinal Products

Application Forms
ADMINISTRATIVE DATA AND PRODUCT INFORMATION (PART 1: SECTION 1) QUALITY REQUIREMENTS FOR DRUG PRODUCT (PART II: SECTION 1) QUALITY REQUIREMENTS FOR DRUG PRODUCT (PART II: SECTION 2) APPEAL FOR REGISTRATION OF REJECTED MEDICINAL PRODUCTS

Guidelines
GUIDE TO APPLICATION FOR REGISTRATION OF MEDICINAL PRODUCTS

Checklist CHECKLIST FOR SUBMISSION OF APPLICATION FOR REGISTRATION OF MEDICINAL PRODUCTS (PART 1) QUALITY REQUIREMENTS FOR DRUG SUBSTANCE (PART II: SECTION 1) QUALITY REQUIREMENTS FOR DRUG SUBSTANCE (PART II: SECTION 2) REQUIREMENTS FOR NON-CLINICAL (PART III) REQUIREMENTS FOR CLINICAL (PART IV)

Log Forms
LOG FOR APPLICATION FOR REGISTRATION OF MEDICINAL PRODUCTS I) LOG FOR ABRIDGED ROUTE (LOA-P /2_/ A_) II) LOG FOR GENERICS & NCES (LOA-P /2_/ GN_) III) LOG FOR NCES (LOA-P /2_/ N_) LOG FOR THE SUBMISSION OF UPDATED DOCUMENTS FOR APPLICATION FOR REGISTRATION OF MEDICINAL PRODUCTS

Guidelines for Forensic Classification of Medicinal Products

Guidelines
GUIDE ON FORENSIC CLASSIFICATION OF PARACETAMOL GUIDE ON FORENSIC CLASSIFICATION OF FOLIC ACID

Variations

Guidelines
GUIDELINE ON APPLICATION FOR VARIATION TO REGISTERED MEDICINAL PRODUCT

Application Forms APPLICATION FORM FOR MINOR VARIATION NOTIFICATION (MiV-N) TO REGISTERED MEDICINAL PRODUCTS (FIRST EDITION - SEPT 2020) APPLICATION FORM FOR VARIATION NOTIFICATION TO REGISTERED MEDICINAL PRODUCTS (FOURTH EDITION - SEPT 2020) PRODUCTS

Log Forms
LOG FOR THE APPLICATION FOR MINOR VARIATION NOTIFICATION (MiV-N) TO REGISTERED MEDICINAL PRODUCTS LOG FOR THE SUBMISSION OF UPDATED DOCUMENTS FOR APPLICATION OF VARIATION TO REGISTERED MEDICINAL PRODUCTS LOG FOR THE APPLICATION FOR VARIATION TO REGISTERED MEDICINAL PRODUCTS

Renewal

Guidelines

GUIDELINE ON APPLICATION FOR RENEWAL OF REGISTRATION OF MEDICINAL PRODUCTS (SECOND EDITION - SEPT 2020)

Checklist

CHECKLIST FOR SUBMISSION OF APPLICATION OF RENEWAL OF REGISTRATION OF MEDICINAL PRODUCT

Application Form
APPLICATION FORM FOR RENEWAL OF REGISTRATION OF MEDICINAL PRODUCTS (THIRD EDITION - SEPT 2020)

Log Form
LOG FOR THE APPLICATION FOR RENEWAL OF REGISTRATION OF MEDICINAL PRODUCTS (SECOND EDITION - SEPT 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

Manufacturing License

Guideline GUIDE ON APPLICATION FOR A LICENCE TO MANUFACTURE OR ASSEMBLE MEDICINAL PRODUCTS GUIDE ON APPLICATION TO AMEND MANUFACTURING LICENCE OF MEDICINAL PRODUCTS

Application Forms
APPLICATION FORM FOR A LICENCE TO MANUFACTURE OR ASSEMBLE MEDICINAL PRODUCTS APPLICATION TO AMEND MANUFACTURING LICENCE OF MEDICINAL PRODUCTS

Application of Medicinal Products for Personal Use (Infographics)

APPLICATION PROCESS OF MEDICINAL PRODUCTS FOR PERSONAL USE (INFOGRAPHICS)

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