Bot50

Regulatory Services

Drug Regulation Services

Regulates approves and and registers drugs and medicines to ensure that medicines used in Botswana meet set standards of safety, efficacy and quality. Authorize the import of medicines for use in clinical trials.

DRU Documents and Forms
Additional Requirement for Products Registered in Stringent Regulatory Authorities
DRU to switch from MH2048 to CTD - Notice (8 January 2015)
Pharmacovigilance Guidelines Nov_2009
Minimum requirements to operate a Pharmaceutical wholesale
Requirements for a Pharmaceutical Wholesaler
Bioanalytical Method Validation FDA 2001
Botswana Checklist for Variations 2009
Guidelines on Dossier Requirements for Variation 2013
Botswana Guidelines for Stability Studies 2009
Botswana Guidelines on Good Manufacturing Practices 2009
Botswana Variations Application Form 2009
Clinical Trial Guidelines
Exemption of Medicines from Registration - Application Form
Guidelines on Application for Registration of Complimentary Medicines June - 2014
Registration of Complimentary medicines - Application Form June 2013
Impurities of New Drug Product ICH 2006
Impurities of New Substances ICH 2006
MH 2050 (2)
Pharmaceutical Development ICH 2009
Qualification and Validation EMEA 2001
Botswana CTD Guidelines


For more information: dunit@gov.bw