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Guidelines and Forms

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A focus on ZA CTD

Amended Documents

Forms

General Documents and Reports

Guidelines – Human Medicines

Guidelines – Miscellaneous

Guidelines – Veterinary Medicines

Index to guidelines and forms

Notification of Registration of a Medicine

Category List(s)

A focus on ZA CTD

2.21_ZA_eCTD_Module_1_Technical_v1(pdf)

2.22_eCTD_Validation_Criteria_v1(pdf)

2.23_Submission_in_eCTD_format_v1(pdf)

2.24_Guidance_General_Module_1_Jul12_v5 (pdf)

2.24_Guidance_General_Module_1_Jul12_v5_showing_changes (MSWord)

2.25_Pharmaceutical and Analytical_CTD_Aug14_v4(PDF)

2.25_Pharmaceutical and Analytical_CTD_Aug14_v4_showing_changes(PDF)

2.26_CTD_implementation_road_map_Oct14_v4(PDF)

2.27_eCTD_checksums_Feb13_v1(pdf_

2.28_eCTD_Questions_and_Answers_Apr13_v1(PDF

6.15_Screening_template_SA_Jun14_v8(MSWord)

6.15_Screening_template_SA_Jun14_v8_showing_changes(PDF)

6.16_Validation_template_eCTD_Jun14_v1(MSWord)

6.16_Validation_template_eCTD_Jun14_v1_showing_changes(PDF)

9.38_Implementation_of_CTD_Jun11_v1(pdf)

Application form Module_1.2.1_Jun14_v5(MSWord)

eCTD Test_submission (zip)

Module_1.2.1_Jun14_v5_showing_changes(PDF)

ZA_CTD_Jul12_v5 (MSWord)

ZA_util

Amended Documents

Forms

6.01_MRF1 application for registration of a medicine (Zip 39kb)

6.03_MRF4_May03_v1 (MSWord)

6.04_Adverse_drug_reactions_form_ARF1_May03_v3(MSWord)

6.05_Application to conduct clinical trials (Zip 36kb)

6.06_CTF2_May03_v1(MSWord)

6.07_Application for additional investigator(s) or change of investigator(s) and application for additional sites (Zip 36kb)

6.08_Application for registration of a veterinary medicine (Zip 65kb)

6.09_Application to amend the details of a parallel imported medicine (Zip 27kb)

6.10_Licence_Application_for_Manufacture_Feb04_v2(MSWord)

6.11_Licence_Application_to_Wholesale_Feb04_v2(MSWord)

6.12_Section_21_Application_Form_Feb04_v1_2(MSWord)

6.13 Guideline Comments Form Dec08 v1

6.14_Application for donation of medicine to South Africa May03_v2(MSWord)

6.15_Screening_template_SA_Jun14_v8(MSWord)

6.16_Validation_template_eCTD_Jun14_v1(MSWord)

6.20 Pre-registration Consultation Meeting Checklist_Jun14_v1(MSWord)

Application form Module_1.2.1_Jun14_v5(MSWord)

General Documents and Reports

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

Guidelines – Human Medicines

2.01_General_information_Jul12_v8 (pdf)

2.01_General_information_Jul12_v8_showing_changes (MSWord)

2.02_PA_Jun11_v6

2.03_Alcohol_content_Dec_03 – Alcohol content of medicines (zipped MS-Word 29kb)

2.04_Post-importation_testing_Dec_03_v1 – Post-importation testing (zipped MS-Word)

2.05_Stability_Jul12_v7_1 (pdf)

2.05_Stability_Jul12_v7_1showing_changes (MSWord)

2.06_Biostudies_Jun11_v5 (MS-Word)

2.07_Dissolution-Mar11_v4 – (MS-Word)

2.08_Amendments_Jul12_v6 (pdf)

2.09_Clinical_Dec_03_v1 – Clinical (zipped MS-Word)

2.10_Substitution_of_medicines_Jan10_v2(MSWord)

2.12_Completing_CT_applications_May03_v1_1(MSWord) – Guideline on completing clinical trial applications

2.13_Post-reg_Amend_Implement_Dec_03_ev1 – Implementation of the post-registration amendment guideline (Zip MS Word)

2.14_Patient Information Leaflets_Dec13_v4(PDF)

2.14_PIL_Dec13_v4_showing_changes(PDF)

2.15_Proprietary_Name_for_Medicines_Nov14_v5_showing_changes(PDF)

2.15_Proprietary_Names_for_Medicines_Nov14_v5(PDF)

2.16_Package Inserts_for_human_medicines_Dec13_v5(PDF)

2.16_PI_for_human_medicines_Dec13_v5_showing_changes(PDF)

2.17_SR-PINs_Mar14_v2(PDF)

2.17_SR-PINs_Mar14_v2_showing_changes(PDF)

2.20_Package Inserts_standardised_texts_Aug14_v3(PDF)

2.20_Package Inserts_standardised_texts_Aug14_v3_showing_changes(PDF)

2.30_Biosimilars_Aug14_v3(PDF)

2.30_Biosimilars_Aug14_v3_showing_changes(PDF)

2.31_FDCs_Jul12_v2 (pdf)

2.32_Wound_Dressings_Nov11_v1(pdf)

2.36_Scheduling_of_Medicines_Jun14_v1(PDF)

2.38_SI_ International Metric System_Jun11_v2(PDF)

2.39 Biological Medicines Pre-registration Consultation Meeting Jun14_v1(PDF)

5.07_Recalls_Dec08_v3 – Guidelines for Recall/Withdrawal of medicines (MS-Word)

7.01_Complementary Medicines – Quality Safety Efficacy_Dec13_v2_1(PDF)

Guidelines – Miscellaneous

5.01_Import_and_Export_May03_v1_1 (MSWord)

5.02_Guideline for parellel importation of medicines in South Africa (Zip 39kb)

5.03_Guideline for completion of annual returns forms (Zip 37kb)

5.05_Guidelines for the destruction of schedule 5 medicines and substances (Zip 64kb )

5.06_Guidelines for the destruction of schedule 6 medicines and substances (Zip 54kb)

5.08 Medicine donations to South Africa_May03_v2(PDF)

5.09_Lodging a complaint on a medicine (MS-Word 91kb)

7.02_Roadmap for Complementary Medicines_Dec13_v1

Guidelines – Veterinary Medicines

3.01_General Information-Jan04_v1 (Zip 121kb)

3.03_Bioavailability and Bioequivalence of veterinary medicines-Jan04_v1 (Zip 65kb)

3.04_Efficacy of and GCP for veterinary medicines-Jun03_v1 (Zip 35kb)

3.05_Guideline on preclinical safety studies for veterinary medicines-Jan04_v1 (Zip 35kb)

3.06_Efficacy of veterinary Biolologicals-Jan04_v1 (Zip 32kb)

3.07_MRLS and withdrawal periods-Jan04_v1 (Zip 75kb)

3.08_Safety of veterinary Biologicals-Jan04_v1 (Zip 35kb)

3.10_Veterinary Drug Recalls-Jan04v1 (Zip 32kb)

3.11_Section 21 applications for unregistered veterinary medicines-Jan04 (Zip 108kb)

3.13_Veterinary_Antimastitis_Medicines_Jun13_v1(PDF)

Index to guidelines and forms

1.01_Index to Guidelines and Forms_Apr13_v3

Notification of Registration of a Medicine

12.49_Notification of Registration Oct09_v1 (MS Word)

12.50_Notification of Registration Dec09-Jan10_v1 (MS Word)

12.51_Notification of Registration Mar10_v1 (MS Word)

12.52_Notification of Registration Apr10_v1 (MS Word)

12.53_Notification of Registration Jun10_v1 (MS Word)

12.54_Notification of Registration Jul10v1 (MS Word)

12.55_Notification of Registration Oct10 v1 (MS Word)

12.56_Notification of Registration Nov10_v1 (MS Word)

12.57_Notification_of_Registration_Feb11v1 (MSWord)

12.58_Notification_of_Registration_Apr11v1 (MSWord)

12.59_Notification_of_Registration_Jun11v1 (MSWord)

12.60_Notification_of_Registration_Aug11v1(pdf)

12.61_Notification_of_Registration_Sep11v1(pdf)

12.62_Notification_of_Registration_Nov11_v1(pdf)

12.63_Notification_of_Registration_Mar12_v1(MSWord)

12.64_Notification_of_Registration_Apr12_v1(MSWord)

12.65_Notification_of_Registration_May12_v1(pdf)

12.66_Notification_of_Registration_Jun12_v1(pdf)

12.67_Notification_of_Registration_Jul12_v1(pdf)

12.68_Notification_of_Registration_Sep12_v1(pdf)

12.69_Notification_of_Registration_Oct12_v1(PDF)

12.70_Notification_of_Registration_Dec12_v1(PDF)

12.71_Notification_of_Registration_Mar13_v1(PDF)

12.72_Notification_of_Registration_Apr13_v1(PDF)

12.73_Notification_of_Registration_Jun13_v1(PDF)

12.74_Notification_of_Registration_Aug13_v1(PDF)

12.75_Notification_of_Registration_Oct13_v1(PDF)

12.76_Notification_of_Registration_Dec13_v1(PDF)

12.77_Notification_of_Registration_Mar14_v1(PDF)

12.78_Notification_of_Registration_Apr14_v1(PDF)

12.79_Notification_of_Registration_Jun14_v1(PDF)

12.80_Notification_of_Registration_Jul14_v1(PDF)

12.81_Notification_of_Registration_Sept14_v1(PDF)

12.82_Notification_of_Registration_Oct14_v1(PDF)

12.83_Notification_of_Registration_Nov14_v1(PDF)

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)