Transcription of MEDICINES CONTROL COUNCIL - mccza.com
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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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Medical Devices Division, Import, PORT QASIM ELECTRIC POWER COMPANY, PORT QASIM ELECTRIC POWER COMPANY (PRIVATE) LIMITED application, INTRODUCTION 10.1 PETROLEUM ACTS AND, INTRODUCTION 10.1 PETROLEUM ACTS AND THE RULES FRAMED THEREUNDER, Application, APPLICATION FOR REGISTRATION OF MOTOR, Hazardous Substances Act