Guidelines and Forms

SOUTH AFRICA

Please visit the MCC webpage for latest information:

www.mccza.com/publications/index/1

www.mccza.com/publications/index/8

Downloads:

10 Licence Application for Manufacture Feb 04 v2

ADR reporting May 03 v1 2

Adverse drug reactions form ARF1 May 03 v3

Aerosol manufacturing Jun 03 v1

Alcohol content Dec 03

Application donated medicines May 03 v2

BA and BE Jan 04 v1

Biostudies Jun 15 v6 showing changes

Biostudies Jun 15 v6

CAMs QSE Dec 13 v2

CAMs ZACTD Mar 14 v2

CAMs ZACTD Mar14 v2 showing changes

Cephalosporin manufacture Jun 03 v1

Clinical Dec 03 v1

Conducta Clinical Trial CTF 1 May 03 v1

CTD implementation road map Feb16 v6

CTF 2 May 03 v1

CTF 3 May 03 v1

CAMs QSE Dec13 v2 1 showing change

eCTD checksums Feb13 v1

eCTD Validation Criteria v1

Efficacy and GCP Jun 03 v1

Efficacy of vetbiologicals Jan 04 v1

General Information Jan 04 v1

General information Jul12 v8 showing changes

Good wholesaling practice Jun 03 v1

Guideline Comments Form Dec 08 v1

Jun 11 v6 showing changes

Licence Application to Wholesale Feb 04 v2

Medical Device IVD Essential Principles Aug 14 v1 for comment

Module 1.2.1 Jun 14 v5 without field in footer

Module_1.2.1_Jun14_v5_showing_changes

MRF 1 Dec 03 v1

MRF 1 May 03 v1

MRF 2 Jun 07 v3

MRF4 May 03 v1

PIF 1 Jun 03 v1

Post importation testing Dec 03 v1

PRC Checklist Jun 14 v1

Pre clinical safety Jan 04 v1

Roadmap for CAMs Dec 13 v1

SA Guide to GMP Jun 10 v5

Screening template SA Jun14 v8 showing changes

Section 21 Application Form Feb 04 v1 2

solator technology Jun 03 v1

Stability Jul12 v7 1

Submission in eCTD format_v1

Substitution of medicines Jan 10 v2

Validation template eCTD Jun14 v1 showing changes

ZA eCTD Jul 12 v5

ZA eCTD Module 1 Technical v1

Information presented here is subject to change. Should you have additional inputs / insights to contribute please contact info@ipasa.co.za.