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 Checksums eCTD Questions & Answers Biosimilars SAHPRA South African Health Products Regulatory Authority Registration of MEDICINES Table of Contents: Guidelines and Forms May 2018 Page 2 of 7 Fixed Dose Combination Products for HIV/Aids, Tuberculosis, and Malari

1.01 Index to Guidelines and Forms 2 Human Medicines 2.01 General information 2.02 Pharmaceutical and Analytical 2.03 Alcohol content of medicines*

Loading..

Information

Related search queries