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Guidelines for Suspension, Withdrawal, Withholding and Revocation of Marketing Authorization of Medical Products and Health Technologies in Kenya

This guideline, issued by the Pharmacy and Poisons Board (PPB), outlines the procedures and criteria for suspending, withdrawing, withholding, or revoking marketing authorisations (MAs) for medicines, vaccines, and other health products and technologies in Kenya. It provides a regulatory framework to protect public health by ensuring that only products meeting standards of quality, safety, and efficacy remain on the market.

Scope

The guideline applies to all health products and technologies granted marketing authorisation by the PPB in Kenya.

Main Content

• Grounds for Regulatory Action– includes product quality defects, safety concerns, efficacy issues, non-compliance with regulatory requirements, or failure to meet conditions of authorisation.
• Types of Actions:
  • Suspension– temporary halt of market authorisation pending resolution of regulatory issues regarding the quality, safety, and efficacy of a health product or technology.
  • Withdrawal–  the voluntary total removal of a Health Product and Technology by the marketing authorization holder
  • Withholding– the delay or pause the issuance of a marketing Authorization or processing of a marketing authorization application until suspected risks on quality, safety and efficacy linked to the application or similar applications are resolved.
  • Revocation– cancellation of marketing authorisation due to violation of the terms and conditions specified in CAP244, the Pharmacy and Poisons Rules, or a condition of the issued certificate.

Procedural Steps– notification to applicants/holders, timelines for corrective action, rights of response, decision-making processes and publishing of the list of all HPTs which apply to this procedure.

Objective

The guideline ensures a transparent, fair, and consistent process for regulatory enforcement, safeguarding public health by removing or restricting unsafe, ineffective, or poor-quality health products from the Kenyan market.

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