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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