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Guideline for submission of variation applications for registered biotherapeutic products

This guideline provides applicants with the necessary steps to submit variation applications for registered human products in accordance with Cap 244 of the Laws of Kenya to the Pharmacy and Poisons Board.

It aims to streamline the process for submitting post-approval changes. Applicants are advised to carefully review the document, paying close attention to the classification of variations, required conditions and documentations and should satisfy themselves that the category selected is suitable for the selected change.

Main content

Variations to registered human medicines are classified based on their impact on safety, quality, and efficacy. Applicants must ensure accurate classification and complete documentation. They include:

• •  Notification: Minor changes with no significant impact on quality, safety, or efficacy that should be notified to regulator
  • Minor Variation (Vmin): Changes with limited impact on quality, safety, or efficacy, requiring submission of documentation and approval.
  • Major Variation (Vmaj): Significant changes that may affect safety, efficacy, or quality, requiring prior approval before implementation

Some variations may require the submission of additional consequential variations. Grouping of variations is permitted only when the changes are directly related and consequential to each other.

The variation application form should then be submitted using the template in Annex 1.

Note: This guideline does not apply to variations for vaccines, biologics, or medical devices, which are covered by separate guidelines.

This is a dynamic document and will be updated periodically based on ongoing experience with variation.

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