Table Of Contents (TOC) for SOUTH AFRICA

SOUTH AFRICA

Authority

MCC: Medicines Control Council

website

www.mccza.com/

if any

DOSSIER REQUIRMENTS

Page

1

Part 1               Introduction

Part 1A            Administrative Data

Part 1B            Comprehensive Table of Contents

Part 1C            Labelling

Part 1D            Foreign Registration

2

  PART 2           BASIS FOR REGISTRATION AND OVERVIEW OF 
  APPLICATION

  Part 2A            Pharmaceutical and biological availability

  Part 2B            Summary basis for registration application (SBRA)

  Part 2C            Pharmaceutical expert report (PER)

  Part 2D            Pre-clinical expert report (PCER)

  Part 2E            Clinical expert report (CER)

3

   Part 3            Pharmaceutical and analytical requirements

Part 3A            Biological Medicine: Primary Production Lot/ Batch

Part 3B            Formulation

Part 3C            Specifications and Control Procedures for Pharmaceutical Ingredients

Part 3D            Containers and Packaging Materials

Part 3E            Manufacturing Procedure

Part 3F            Biological Medicine Final Filling Lot & Diluent

Part 3G            Stability Data of the Finished Pharmaceutical Product (FPP)

Part 3H            Pharmaceutical Development

4

Part 4   Pre-Clinical Studies

5

Part 5   Clinical Studies