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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 for CTD CTD Implementation Road Map eCTD Ch
Registration of Medicines Table of Contents: Guidelines and Forms . 1.01_Contents_May18_v6.docx May 2018 . Page 2 of 7. 2.31 Fixed Dose Combination Products for HIV/Aids, Tuberculosis, and Malaria
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