Regulatory 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 2018
• 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