Transcription of GUIDELINES FOR SUBMITTING APPLICATION FOR …
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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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EVDAS training for Marketing Authorisation Holders, Arnicare Arnica 30c pillules NR, ARNICARE ARNICA 30C PILLULES, NR, Marketing authorisation, Addressing specific regulatory excipient, Marketing, PERSONAL NEW ACCOUNT APPLICATION FORM, November 2011, Public Assessment Report, Consumer protection act, PROVIDE INFORMATION ABOUT THE MEDICINAL PRODUCT