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MEDICINES CONTROL COUNCIL - mccza.com

Registration of MEDICINES Table of Contents: Guidelines and Forms May 2018 Page 1 of 7 GUIDELINES and FORMS TABLE OF CONTENTS 1 Guidelines and Forms Index to Guidelines and Forms 2 Human MEDICINES General information Pharmaceutical and Analytical Alcohol content of MEDICINES * Post-importation testing* Stability * Biostudies Dissolution* Amendments* Clinical Substitution of MEDICINES Adverse Drug Reactions Reporting Completing clinical trial applications (to be updated) Implementation of the post-registration amendments guideline Patient Information Leaflet (PIL) Proprietary names for MEDICINES Package Inserts for human MEDICINES Safety-related Package Insert Notifications (SR-PINs) Package Insert standardised texts ZA eCTD Module 1 Technical eCTD Validation Criteria Submission in eCTD format Guidance for the Submission of the ZA CTD / eCTD General & Module 1 Pharmaceutical &Analytical

6.01 MRF1 Medicine Registration Application (Human) - replaced by ZA-CTD . 6.02 MRF2 Screening of Application* 6.03 MRF4 Package Insert Amendments*

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