Introduction
The pharmacovigilance regulations and landscape in Kenya are rapidly changing.
In 2023, the Kenya Pharmacy and Poisons Board updated the Kenya guidelines for the establishment of qualified persons for pharmacovigilance.
This guideline describes the obligations of the Marketing Authorization Holders to set up a pharmacovigilance system master file through the appointment of qualified persons for pharmacovigilance.
The following major changes were introduced;
- Qualifications of QPPV: Expunged the requirement of a Master’s degree in pharmacoepidemiology and pharmacovigilance within 5 years from designation. The requirement to have a valid QPPV practice license replaced with a letter of designation as QPPV from PPB after his/her nomination by MAHs.
- QPPV Back Up: Back-up QPPV shall also reside in Kenya, and will have all the qualifications of the QPPV.
- Role and responsibilities of QPPV: Expunged the word establishing under bullet 1 to only have maintain the PSMF as the establishment is the role of MAH, added that QPPV shall act on MAH’s behalf including liaising with the Board Introduced the Roles and responsibilities of the appointed focal persons for PV (FPPV)
- Outsourcing of QPPV: Nominated QPPV shall be limited to not more than 5 companies.
Below is the implementation notification.
To access the full guideline, use this link
For any questions about the implementation process, contact us.
