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Guidelines and Forms

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Forms

General Documents and Reports

Guidelines - Human Medicines (new)

Guidelines - Miscellaneous

Index to guidelines and forms

Notification of Registration of a Medicine

Category List(s)

Forms

Application for additional investigator(s) or change of investigator(s) and application for additional sites (zipped MS-Word 36kb)

Application for registration of a veterinary medicine (zipped MS-Word 65kb)

Application to amend the details of a parallel imported medicine (zipped MS-Word 27kb)

Application to conduct clinical trials (zipped MS-Word 36kb)

ARF1 - Adverse drug reactions reporting forM (zipped MS-Word 44kb)

MRF1 application for registration of a medicine (zipped MS-Word 39kb)

MRF2 - application for registration of a medicine - screening form (zipped MS-Word 50kb)

Section 21 application form (zipped MS-Word 39kb)

General Documents and Reports

Technical Report - Antimicrobial resistance congress (zipped MS-Word 94kb)

Guidelines - Human Medicines (new)

2.01 - General Information - V6 (zipped MS-Word 120kb)

2.03 - Alcohol content of medicines (zipped MS-Word 29kb)

2.05 - Stability (New - June 2009) (MS-Word 237kb)

2.06 - Biostudies - V3 (zipped MS-Word 67kb)

2.07 - Dissolution - V3 (zipped MS-Word 47kb)

2.08 - Post-registration amendments - V4 (zipped MS-Word 109)

2.09 - Clinical (zipped MS-Word 79kb)

2.10 - Generic substitution - V2 (subst of med) (zipped MS-Word 28kb)

2.12 - Completing clinical trial applications (zipped MS-Word 32kb)

2.14 - Guideline on the requirements for patient information leaflets (zipped MS-Word 45kb)

5.07 - Guidelines for Recall/Withdrawal of medicines (MS-Word 204kb)

9.08 - Process for handling dear health care professional letters and medicine safety alerts (Ms-Word 76kb)

Guidelines - Miscellaneous

9.07 - ADR terminology used in package inserts (MS-Word 53kb)

9.24 - Guidance to industry regarding submission of the screening copy of an application for registration of a medicine

9.24 - MCC and expert committees - meeting dates for 2009 (MS-Word 77kb)

Guideline for completion of annual returns forms (zipped MS-Word 37kb)

Guideline for electronic submission applications for registration of medicines - Pilot project (zipped MS-Word 31kb)

Guideline for parellel importation of medicines in South Africa (zipped MS-Word 39kb)

Guidelines for the destruction of schedule 5 medicines and substances (zipped MS-Word 64kb )

Guidelines for the destruction of schedule 6 medicines and substances (zipped MS-Word 54kb)

Guidelines for the importation and exportation of medicines (zipped MS-Word 64kb)

Lodging a complaint on a medicine (MS-Word 91kb)

Medicine donations to South Africa (zipped MS-Word 32kb)

Index to guidelines and forms

Index to Guidelines and Forms (MS-Word 58kb)

Notification of Registration of a Medicine

April 2003 (MS-Word 99kb)

April 2004 (MS-Word 52kb)

April 2005 (MS-Word 74kb)

April 2007 (Amended) (zipped MS-Word 29kb)

April 2008

April 2009 (MS-Word 115kb)

August 2009 (MS-Word 116kb)

August 2003 (MS-Word 48kb)

August 2006 (zipped MS-Word 36kb)

August 2007 (zipped MS-Word 31kb)

August 2008 (zipped MS-Word 35kb)

December 2003 (MS-Word 63kb)

December 2006 (zipped MS-Word 32kb)

December 2008 (zipped MS-Word 40kb)

February 2004 (MS-Word 53kb)

February 2005 (MS-Word 115kb)

February 2006 (MS-Word 142)

February 2007 (Amended) (zipped MS-Word 29kb)

February 2008(updated) (zipped MS-Word 35kb)

January 2003 (MS-Word 65kb)

July 2003 (MS-Word 66kb)

July 2004 (MS-Word 91kb)

July 2005 (zipped MS-Word 37kb)

July 2006 (zipped MS-Word 37kb)

June 2003 (MS-Word 79kb)

June 2005 (zipped MS-Word 39kb)

June 2007 (MS-Word 79kb)

March 2003 (MS-Word 75kb)

March 2005 (MS-Word 111kb)

March 2007 (zipped MS-Word 29kb)

March 2009 (MS-Word 94kb)

May 2003 (MS-Word 51kb)

May 2004(1) (MS-Word 62kb)

May 2004(2) (MS-Word 78kb)

November 2004 (MS-Word 86kb)

November 2005 (zipped MS-Word 52kb)

November 2007 (zipped MS-Word 34kb)

October 2003 (MS-Word 82kb)

October 2004 (MS-Word 46kb)

October 2006 (MS-Word 85kb)

October 2007 (zipped MS-Word 37kb)

October 2008 (zipped MS-Word 35kb)

September 2003 (MS-Word 108kb)

September 2004 (MS-Word 98kb)

September 2005 (zipped MS-Word 52kb)