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PPB Variation
Dossier Classifier
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Tools Hub
Variation Classifier
Select Change Type
Select Post-Approval Change
Change of applicant / marketing authorization holder name
Change of finished product brand name
Change or addition of secondary packaging site
Change or addition of finished product manufacturing site
Change or addition of API (Active Ingredient) supplier
Change in product formulation (inactive excipients)
Change in active ingredient dose / strength
Extension of finished product shelf life
Change in storage conditions (e.g. temperature range)
Classification Result
PPB Variation Category
Minor Variation (MiV)
PPB Fee (USD)
$250
Timeline
90 Days
Required Dossier Documentation
Discuss Variation Dossier Prep →
