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Guideline for Submission of Variation Applications for Registered Human Vaccines

Issued by the Pharmacy and Poisons Board (PPB), this guideline outlines the process for submitting variation applications for registered human vaccines in Kenya. It specifies the conditions that must be met and the required documentation before a proposed change can be approved. The guideline ensures that all modifications to approved vaccines continue to uphold the highest standards of safety, quality, and efficacy.

Scope

Covers all types of variations to registered vaccines, including:Administrative changes (e.g., labeling, packaging), Quality-related updates (e.g., manufacturing process, formulation) and safety and efficacy changes including those that may require new evaluations or approvals.

This Guideline is only applicable to human vaccines.

Main content

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

• Annual Notification (AN): Minor changes with no significant impact, reported within 12 months of implementation.
• Immediate Notification (IN): Minor changes with minimal impact, that may be implemented within 30 days of reporting.
• 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

Certain changes are considered so fundamental that they alter the terms of the approved dossier. As such, they cannot be treated as variations and must be submitted as new marketing authorization applications.

Some variations may require submission of additional consequential variations..

Grouping of variations is permitted only when the changes are directly related and consequential to each other.

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