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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.
4 ABBREVIATIONS: API Active pharmaceutical ingredient(s) ATC Anatomical therapeutic classification BA Bioavailability BE Bioequivalence
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