Guidelines for Establishment of the Qualified Persons for Pharmacovigilance

The Pharmacy and Poisons Board as the National Medicines Regulatory Authority in Kenya has the responsibility of ensuring the quality, safety and efficacy of Health Products and Health Technologies. This guideline describes the obligations of the Marketing Authorization Holder to set up a pharmacovigilance system master file through the establishment of qualified persons for pharmacovigilance in order to ensure they collect, collate and evaluate information about suspected adverse reactions and quality problems of products it puts into the Kenyan market. These guidelines apply to all entities that have the authorization to put Health Products and Health Technologies into the Kenyan market.

MAH shall be required to have a QPPV person at his disposal who shall meet specific required qualifications as stipulated in the guideline. The QPPV shall be the contact person between the Board and MAH and hence shall perform all the roles of a QPPV. From time to time, as shall be stipulated in the Good Pharmacovigilance Practice Guidelines, the Board shall carry out pharmacovigilance inspections at the MAH offices and at the outsourced offices in order to ensure compliance with the law and this Guideline.

Regulatory sanctions shall be applied to the MAH, local representative, manufacturer, and/or the QPPV in the case of non-compliance to the regulations in these guidelines.

The sanctions shall depend on whether the non-compliance shall be critical, major, or minor.

This guideline should be read and used alongside the Guidelines on the Safety and Vigilance of Health Products and Technologies and the Pharmacovigilance and Post Marketing Surveillance Rules 2022