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Guidelines for Establishment of the Qualified Persons for Pharmacovigilance

The Pharmacy and Poisons Board, as the National Regulatory Authority in Kenya, has the responsibility of ensuring the quality, safety, and efficacy of HPTs. Marketing Authorization Holders/Manufacturers, as owners of these products in Kenya, have a shared responsibility of ensuring that their products in the Kenyan market meet the highest standard of quality, safety, and efficacy. The Pharmacovigilance and Post-Marketing Surveillance Rules, 2022, contain the roles and responsibilities of the MAH towards ensuring the safety and efficacy of their products in the market.

Key Responsibilities of MAHs

• Establish a Pharmacovigilance System Master File:
  • Maintain a centralized document describing the pharmacovigilance system.
  • Ensure the system complies with Kenyan regulations.
• Appoint a Qualified Person for Pharmacovigilance (QPPV):
  • The QPPV must meet specific qualifications as detailed in this guideline.
  • Act as the main liaison between the PPB and the MAH.
• Compliance with Reporting Requirements:
  • Collect, collate, and evaluate data on adverse drug reactions and quality issues.
  • Submit reports as required under the Pharmacovigilance and Post-Marketing Surveillance Rules, 2022.
• Facilitate Pharmacovigilance Inspections:
  • Be prepared for routine and ad hoc inspections by PPB at MAH or outsourced offices.

Non-Compliance and Regulatory Sanctions

Sanctions will apply in cases of non-compliance by the MAH, local representative, manufacturer, or QPPV. The three main types of non-compliance include;

• Critical Non-Compliance:Serious lapses impacting public safety.
• Major Non-Compliance:Significant violations requiring corrective action.
• Minor Non-Compliance:Low-risk issues needing attention.

The PPB will evaluate and enforce sanctions based on the severity of non-compliance.

This guideline, therefore, lays down the obligations of the Marketing Authorization Holders to set up a pharmacovigilance system master file through the establishment of qualified persons for pharmacovigilance to ensure they collect, collate, and evaluate information about suspected adverse reactions and quality problems of products it puts into the Kenyan market.

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