MCC Structure
 MRA Structure
 MRA Contact Details
Documents under section: Guidelines - Human Medicines
 
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PHARMACEUTICAL AND ANALYTICAL (Zipped MS-Word 60Kb)
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ALCOHOL CONTENT OF MEDICINES (Zipped MS-Word 29Kb)
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POST-IMPORTATION TESTING (Zipped MS-Word 36Kb)
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BIOSTUDIES (zipped MS-Word 67Kb)
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GENERIC SUBSTITUTION (Zipped MS-Word 28Kb)
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REPORTING ADVERSE DRUG REACTIONS IN SOUTH AFRICA (Zipped MS-Word 49Kb)
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IMPLEMENTATION OF THE POST-REGISTRATION AMENDMENTS GUIDELINE (Zipped MS-Word 36Kb)
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DISSOLUTION (zipped MS-Word 47Kb)
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PHARMACEUTICAL AND ANALYTICAL (zipped MS-Word 77Kb)
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PHARMACEUTICAL AND ANALYTICAL (NEW JUNE 2007) (zipped MS-Word 77Kb)
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COMPLETING CLINICAL TRIAL APPLICATIONS (Zipped MS-Word 32Kb)
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GUIDELINE ON THE REQUIREMENTS FOR PATIENT INFORMATION LEAFLETS (Zipped MS-Word 45Kb)
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AMENDMENT TO PHARMACEUTICAL AND ANALYTICAL GUIDELINE (Part 3) (MS-Word 51Kb)
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CLINICAL (Zipped MS-Word 79Kb)
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STABILITY (Zipped MS-Word 60Kb)
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PHARMACEUTICAL AND ANALYTICAL (NEW jUNE 2007) (zipped MS-Word 77Kb)
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POST-REGISTRATION AMENDMENTS (MS-Word 615Kb)
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GENERAL INFORMATION (zipped MS-Word 120Kb)
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PACKAGE INSERTS FOR HUMAN MEDICINES (zipped MS-Word 55Kb)