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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.

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.

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