Guidelines for the Establishment of the Qualified Person for Pharmacovigilance

The Pharmacy and Poisons Board as the National Medicines Regulatory Authority in Kenya has the responsibility of ensuring quality, safety and efficacy of medical products and health technologies. This guideline describes the obligations of the Marketing Authorization Holder to set up a pharmacovigilance system master file through establishment of a 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 authorization to put medical products and health technologies into the Kenyan market.

MAH will be required to have a QPPV person at his disposal who will meet specific required qualifications as stipulated in the guideline. The QPPV will be the contact person between the Board and MAH and hence will perform all the roles of a QPPV. From time to time as will be stipulated in the Good Pharmacovigilance Practice Guidelines, the Board will 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 will depend on whether the non-compliance will be critical, major or minor.