Regulatory Services

Botswana CTD Guidelines

N.B Suspension of Receiving Applications for Registration by MoHW
• Botswana Guideline in BA & BE April 2015
• Botswana Registration Quality Guideline April 2015
• Botswana CTD-Format July 2016
• Application form - May 2016
• Bioeq Trial Info Form April 2015
• Quality Overall Summary July 2016
• Applicant MRA Checklist February 2017
• Quality QIS August 2015
• BioWaiver-Additional Strengths Application Form April 2015
• BioWaiver-BCS Application Form April 2015
• Botswana Guideline on Renewal of Registration and Application of B Listed Medicines









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