Legislation / Regulation

Other Legislation

Listed here, as a service, are the documents PIASA thought most relevant. The list is not exhaustive. Should you wish to search further you can access the Department of Health website: www.doh.gov.za

Botswana Addendum to GUIDELINES FOR REGISTRATION OF MEDICINE Final December 2010.pdf
Botswana Draft Conduct of Clinical Trials Guideline June 2009.pdf
Botswana Guidelines for Reporting Adverse Drug Events November 2008.pdf
Botswana PV Guidelines Nov 2009 2nd Edition.pdf
Botswana Regulatory requirements June 2009.pdf
Clinical Trials - Regulatory requirements SENEGAL, 2012.xlsx
Clinical Trials - Regulatory requirements SOUTH AFRICA, 2012.xlsx
Clinical Trials - Regulatory requirements UGANDA, 2012.xlsx
Clinical Trials - Regulatory requirements ZAMBIA, 2012.xlsx
Clinical Trials - Regulatory requirements ZIMBABWE, 2012.xlsx
Ethiopia Regulatory requirements.pdf
Ghana Guideline for conducting Clinical Trials.pdf
Ghana Guidelines for Product Safety Monitoring.pdf
Kenya Guideline for Pharmcovigilance February 2009.pdf
Kenya Registration New_Form_1.pdf
Kenya Registration of Drugs New_Drug_Reg_Guideline.pdf
Kenya Report form for ADR.pdf
Kenyan PPB-Medical Device Registration Guidelines.pdf
Kenyan SMS BASED DRUG ANTI-COUNTERFEITING SYSTEM.pdf
Madagascar Procedure_Enregistrement_2010.pdf
Madagascar Registration Requirements.pdf
Malawi Regulatory requirments September 2009.pdf
Namibia Medicines Recall Guideline, Aug 2011.pdf
Namibia Post Registration Amendments Guideline.pdf
Namibia Regulatory Requirements.pdf
Namibian GRN Notice 4756 - Veterinary medicines 15 July 2011.pdf
Nigeria Form for reporting suspected ADR.pdf
Nigeria Good Pharmacovigilance Practice 2009.pdf
Nigeria Guideline to reporting ADR.pdf
Reg Authorities in Africa.pdf
Rwanda Requirements for the supply of pharmaceuticals.pdf
Tanzania Guideline for Monitoring and Reporting ADR.pdf
Tanzania New Registration Fees 2011.pdf
Tanzania Report form for ADR.pdf
Zambia Adverse Drug Event Form.pdf
Zambia Clinical Trials - Regulatory requirements, 2012.xlsx
Zambia Regulatory requirements April 2006.pdf
Zimbabwe Clinical Trials - Regulatory requirements, 2012.xlsx
Zimbabwe Form for reporting ADR.pdf
Zimbabwe Guideline for Pharmacovigilance and Clinical Trials.pdf