What steps and deadlines apply if the regulator rejects my new medicine's product registration in Kenya?

In Kenya
Last Updated: Oct 31, 2025
I'm preparing to register a new medicine with the Kenyan regulator, but they say the submission lacks required data and may be rejected. What rights do I have to appeal or re-submit, what processes are involved, and what timelines and costs should I expect in a regulatory review?

Lawyer Answers

BEGI'S LAW OFFICES & CHAMBERS

BEGI'S LAW OFFICES & CHAMBERS

Oct 31, 2025
Best Answer
In the case of a decision of refusal to register your medicine by the Kenya Pharmacies and Poisons Board, our advice is that you consider filing a motion for judicial review at the High Court Judicial Review Division. A decision to reject registration is usually administrative in nature and is subject to supervision by the court through judicial review. First step involves getting leave of court which takes about 2 weeks and the substantive motion takes about 3 months to complete. Kind regards. Elvis Abenga. Begi's Law Offices & Chambers.
BEGI'S LAW OFFICES & CHAMBERS

BEGI'S LAW OFFICES & CHAMBERS

Oct 31, 2025
In the case of a decision of refusal to register your medicine by the Kenya Pharmacies and Poisons Board, our advice is that you consider filing a motion for judicial review at the High Court Judicial Review Division. A decision to reject registration is usually administrative in nature and is subject to supervision by the court through judicial review. First step involves getting leave of court which takes about 2 weeks and the substantive motion takes about 3 months to complete. Kind regards. Elvis Abenga. Begi's Law Offices & Chambers.
BEGI'S LAW OFFICES & CHAMBERS

BEGI'S LAW OFFICES & CHAMBERS

Oct 31, 2025
In the case of a decision of refusal to register your medicine by the Kenya Pharmacies and Poisons Board, our advice is that you consider filing a motion for judicial review at the High Court Judicial Review Division. A decision to reject registration is usually administrative in nature and is subject to supervision by the court through judicial review. First step involves getting leave of court which takes about 2 weeks and the substantive motion takes about 3 months to complete. Kind regards. Elvis Abenga. Begi's Law Offices & Chambers.
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