MCC Structure
MRA Structure
MRA Contact Details
Documents under section:
Guidelines for Medicine Registration
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GENERAL INFORMATION ON GUIDELINES FOR REGISTRATION OF MEDICINES IN SOUTH AFRICA (zipped PDF 420Kb)
6/16/2003 7:27:30 AM
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GUIDELINE FOR APPLICATIONS TO AMEND THE REGISTRATION DOSSIER OF A MEDICINE – Revised (zipped PDF 212Kb)
6/16/2003 7:28:38 AM
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GUIDANCE DOCUMENT: GOOD MANUFACTURING PRACTICE FOR MEDICINES IN SOUTH AFRICA (zipped PDF 610Kb)
6/16/2003 7:30:43 AM
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GUIDELINES FOR CLINICAL REQUIREMENTS (zipped PDF 306Kb)
6/16/2003 7:32:00 AM
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GUIDE TO COMPLETING CLINICAL TRIAL APPLICATION FORM (zipped PDF 183Kb)
6/16/2003 7:32:54 AM
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GUIDELINES FOR PHARMACEUTICAL AND ANALYTICAL REQUIREMENTS (zipped PDF 238Kb)
6/16/2003 7:34:09 AM
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ADDENDUM 1-ALCOHOL CONTENT (zipped PDF 131Kb)
6/16/2003 7:34:55 AM
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ADDENDUM 2-VALIDATION PROTOCOLS AND VALIDATION REPORTS (zipped PDF 175Kb)
6/16/2003 7:35:49 AM
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ADDENDUM 3-POST-IMPORTATION IDENTIFICATION AND TESTING OF MEDICINES (zipped PDF 154Kb)
6/16/2003 7:36:41 AM
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ADDENDUM 4-STABILITY STUDIES (zipped PDF 183Kb)
6/16/2003 7:37:34 AM
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ADDENDUM 5 – BIOAVAILABILITY AND BIOEQUIVALENCE DATA REQUIRED AS PROOF OF EFFICACY (zipped PDF 321Kb)
6/16/2003 7:38:44 AM
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ADDENDUM 6-DISSOLUTION TESTING (zipped PDF 217Kb)
6/16/2003 7:39:38 AM
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GUIDELINES FOR RECALL OF MEDICINES (zipped PDF 188Kb)
6/16/2003 7:41:12 AM
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REPORTING ADVERSE DRUG REACTIONS IN SOUTH AFRICA (zipped PDF 242Kb)
6/16/2003 7:42:21 AM
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GUIDELINES FOR THE DESTRUCTION OF SCHEDULE 5 – MEDICINES AND SUBSTANCES (zipped PDF 155Kb)
6/16/2003 7:43:59 AM
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GUIDELINE FOR COMPLETION OF ANNUAL RETURNS FORM (zipped PDF 99Kb)
6/16/2003 7:46:02 AM
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GUIDELINES FOR MEDICINE DONATIONS TO SOUTH AFRICA (zipped PDF 176Kb)
6/16/2003 7:47:27 AM
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GUIDELINES FOR AEROSOL MANUFACTURING (zipped PDF 64Kb)
6/16/2003 7:48:37 AM
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GUIDELINES FOR ISOLATOR TECHNOLOGY (zipped PDF 104Kb)
6/16/2003 7:49:57 AM
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GUIDELINES FOR PENICILLIN MANUFACTURING (zipped PDF 71Kb)
6/16/2003 7:50:44 AM
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GUIDELINES FOR RADIOPHARMACEUTICAL MANUFACTURING (zipped PDF 72Kb)
6/16/2003 7:51:54 AM
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GUIDELINE FOR PARALLEL IMPORTATION OF MEDICINES IN SOUTH AFRICA (zipped PDF 107Kb)
6/16/2003 7:53:02 AM
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GUIDELINE ON GENERIC SUBSTITUTION (NON-SUBSTITUTABLE)(zipped PDF 64Kb)
6/16/2003 7:54:16 AM
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GUIDELINE FOR GOOD WHOLESALING PRACTICE FOR WHOLESALERS, DISTRIBUTORS and BONDED WAREHOUSES (zipped PDF 106Kb)
6/16/2003 7:56:27 AM
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GUIDELINE FOR ELECTRONIC SUBMISSION OF APPLICATIONS FOR REGISTRATION OF MEDICINES – PILOT PROJECT (zipped PDF 82Kb)
6/16/2003 7:57:33 AM
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GUIDELINES FOR THE DESTRUCTION OF SCHEDULE 6 MEDICINES AND SUBSTANCES (PDF 280Kb)
9/3/2003 1:50:21 AM
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GUIDELINES FOR PREPARATION OF SITE MASTER FILE (zipped WS-Word 134Kb)
9/3/2003 2:36:50 AM
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GUIDELINES FOR PREPARATION OF SITE MASTER FILE (zipped PDF 111Kb)
9/3/2003 2:37:35 AM
