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

Em Kenya
Última Atualização: 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?

Respostas de Advogados

BEGI'S LAW OFFICES & CHAMBERS

BEGI'S LAW OFFICES & CHAMBERS

Oct 31, 2025
Melhor Resposta
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.
FAZER PERGUNTA GRATUITA

Gratuito • Anónimo • Advogados Especialistas

Precisa de Ajuda Jurídica Pessoal?

Conecte-se com advogados experientes na sua área para aconselhamento personalizado sobre a sua situação específica.

Gratuito e sem compromisso.

Especialistas Jurídicos Relacionados

Obtenha ajuda personalizada de advogados especializados nesta área

Desde 2021
7 advogados
15 minutes Gratuito
Banca e Finanças Família Energia, Meio Ambiente e ESG +1 mais
Ligar Agora
Desde 2013
7 advogados
Banca e Finanças Emprego e Trabalho Energia, Meio Ambiente e ESG +1 mais
Ligar Agora
Desde 2021
10 advogados
15 minutes Gratuito
Banca e Finanças Litígios e disputas Negócios +1 mais
Ligar Agora

Todos os advogados são profissionais verificados e licenciados com historial comprovado