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Guideline on Evaluation And Authorisation of Unregistered Health Products and Technologies

Introduction:

The Guideline on Evaluation and Authorization of Unregistered Health Products and Technologies (UHPTs), developed by the Pharmacy and Poisons Board (PPB), outlines the process for accessing unregistered medicines in Kenya that may be urgently required to address unmet patient medical needs.

It ensures that such authorizations are granted in compliance with the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, while safeguarding patient safety, product quality, and public health.

Scope:

This guideline applies to manufacturers, importers, healthcare providers, health institutions, and licensed dealers seeking authorization to use, import, or distribute (as prescribed by the Board) unregistered health products.

This guideline applies to unregistered medicines, vaccines, and other health products intended for human use in Kenya under exceptional circumstances. These include situations where registered alternatives are unavailable, unsuitable, or ineffective

It covers scenarios such as:

• Individual named-patient access where conventional therapies have failed, are unsuitable, or unavailable.
• Bulk stock authorization for health establishments, where urgent availability is necessary for emergency or critical care.
• Bulk stock for licensed dealers, in exceptional cases where centralized storage and rapid distribution is required.

Main Content

The guideline provides:

• Eligibility criteria and application process, including needs assessments, supporting documentation, and justification requirements.
• Evaluation process, detailing review timelines, decision-making, and conditions for authorization.
• Renewal procedures, record-keeping, and reporting obligations.
• Pharmacovigilance and safety monitoring, ensuring that adverse events and product quality issues are reported promptly.

Attached Files