Interactive Utilities

Regulatory Tools & Compliance Resources

Navigate pharmaceutical regulations across East and Southern Africa using our interactive compliance utilities.

PPB Fees & Retention Calculator

Calculate registration, annual retention, and GMP inspection fees charged by the Pharmacy and Poisons Board (PPB) in Kenya. Supports imported and locally manufactured categories.

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PPB Variation Classifier

Determine whether post-approval changes to your registered products represent Major Variations, Minor Variations, or Notifications, and see the required dossier checklists.

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Premium Resource

PPB Dossier Submission Checklist & Template

A comprehensive checklist for Module 1, Module 3 (Quality), and Module 5 (Clinical/BE) dossiers required by the Pharmacy and Poisons Board in Kenya. Compiled by our senior regulatory consultants to guarantee compliance.

✓ Complete Administrative Module requirements
✓ GMP inspection prep details
✓ Bioequivalence parameters for generics

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