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GUIDELINES FOR SUBMITTING APPLICATION FOR …
1 GUIDELINES FOR SUBMITTING APPLICATION FOR REGISTRATION OF A MEDICINE 2007 2 TABLE OF CONTENTS i. ABBREVIATIONS ii. FOREWORD iii. INTRODUCTION iv. GLOSSARY 1. APPLICATION FORM FOR REGISTRATION AND MARKETING OF A MEDICINE IN THE SADC REGION 1 2. GUIDELINES FOR SUBMITTING applications GENERAL INFORMATION 1. Applicants 14 2. APPLICATION forms 14 3. APPLICATION fees 14 4. Confidentiality 15 5. Same / Separate applications 15 PART I PART IA: ADMINISTRATIVE INFORMATION 1. Details of applicant 17 2. Details of responsible person 17 3. Details of manufacturer 17 4. Source (manufacturer) of active Pharmaceutical Ingredient(s) 17 5. Product information 17 6. Registration Status 18 7. Proposed Indications 19 8.
4 ABBREVIATIONS: API Active pharmaceutical ingredient(s) ATC Anatomical therapeutic classification BA Bioavailability BE Bioequivalence
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