Free Regulatory Tool

Variation Classifier

Classify post-approval variations as Type IA, IB, or II and see what PPB documentation is required.

What's changing?

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Select a variation type

Disclaimer

This classifier is based on the EAC Harmonized / PPB post-approval variation guidelines and is for planning purposes only. Final classification depends on product context, the reason for change, and may differ for complex biologicals. Always confirm with PPB before submitting.

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What is a Post-Approval Variation?

A post-approval variation is any change made to a medicine after it has already received marketing authorisation from the regulator. Once a product is registered with the Pharmacy and Poisons Board (PPB) in Kenya, its approved details (the manufacturing site, the formulation, the pack size, the shelf life, the labelling and the safety information) become fixed conditions of that registration. If a marketing authorisation holder (MAH) or distributor wants to change any of those details, the change must be classified, documented and routed through the correct PPB pathway before or after implementation depending on its risk.

East African Community member states, including Kenya, follow the EAC harmonised guidelines for variations, which sort each change into three risk tiers. Type IA covers minor administrative changes that carry no measurable impact on quality, safety or efficacy, so they can be implemented and then notified to PPB. Type IB covers minor changes that still need a short regulatory review before they take effect. Type II covers major changes, such as a new manufacturing site or a change of primary packaging material, that require a full technical assessment and written PPB approval before the change reaches the market.

Getting the classification right matters because it sets the documentation burden, the timeline and the legal exposure. Filing a major change as a minor notification can lead to a rejected submission, a compliance query, or a product being treated as unregistered in its new form. This tool maps each common change to its likely Type IA, IB or II category and lists the dossier sections PPB will expect, so you can plan the submission before you start assembling evidence.

How to Use This Variation Classifier

1

Pick the Change

Scan the list of common post-approval changes and select the one that matches what you intend to vary on your registered product, from a name change to a new manufacturing site.

2

Read the Classification

The tool returns the likely variation type (IA, IB or II), the reason for that category, and the PPB route, whether it is do-and-tell, tell-wait-do, or prior approval.

3

Assemble the Dossier

Use the documentation checklist as your starting point for the variation application, then confirm the final list with PPB before you submit. Complex biologicals may need extra data.

Frequently Asked Questions

What is a post-approval variation?+
A post-approval variation is any change to a medicine that is made after it has received marketing authorisation. Because the manufacturing site, formulation, pack size, shelf life and labelling are all conditions of the original registration, any change to them must be classified and submitted to the regulator. In Kenya these changes are handled by the Pharmacy and Poisons Board under the EAC harmonised variation guidelines.
What is the difference between Type IA, IB and Type II variations?+
Type IA is a minor variation with no measurable impact on quality, safety or efficacy, so it can be implemented first and notified to PPB afterwards. Type IB is a minor variation that needs a short regulatory review before it takes effect, often described as tell-wait-do. Type II is a major variation, such as a new manufacturing site or a change of primary packaging, that requires a full technical assessment and written PPB approval before the change can reach the market.
Do I submit a variation before or after I make the change?+
It depends on the type. A Type IA minor change can be implemented and then notified to PPB, usually within 12 months of the change. A Type IB change is submitted and you wait for the review period to pass without objection before implementing. A Type II major change must be approved in writing by PPB before you make it, so the change cannot reach the market until the regulator signs off.
How long does PPB take to review a variation?+
Timelines vary by tier. Type IA notifications are accepted on a do-and-tell basis, so there is no waiting period before implementation. Type IB changes follow a tell-wait-do model with a defined review window. Type II major variations typically take several months because they involve a full technical assessment, and the published review periods can be extended if PPB raises queries that need a response.
What documents are required for a variation application?+
Every variation needs a cover letter, the completed variation application form, and a justification for the change. Beyond that, the supporting data scales with the risk tier, ranging from updated labels and specifications for minor changes to comparative stability data, process validation, GMP certificates and updated CTD Module 3 sections for major changes. This tool lists the typical documents for each change so you can prepare the dossier before submission.
Does this classifier apply to products registered in Kenya?+
Yes. The classifications follow the EAC harmonised variation guidelines that PPB applies to products registered in Kenya, and the documentation lists reflect the dossier sections PPB expects. The same harmonised framework is used across other East African Community member states, so the categories are broadly consistent in the region. Always confirm the final classification and document set with PPB, since product context can change the outcome.
Is this variation classifier free to use?+
Yes, the classifier is completely free and needs no sign-up or account. You can use it as many times as you like to plan variation submissions for any number of products. It runs entirely in your browser and does not store the changes you select.
Does this tool replace official PPB guidance?+
No. The classifier is a planning aid that helps you anticipate the likely variation type and documentation, but it is not a regulatory determination. Final classification depends on the specific product, the reason for the change, and may differ for complex biologicals or combination products. Always confirm the category and the required dossier with PPB before you submit.

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