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Guidelines on Medicines and Vaccines Renewals

Issued by the Pharmacy and Poisons Board (PPB) under the Ministry of Health, Kenya, these guidelines define the requirements and procedures for the renewal of marketing authorizations for medicines and vaccines. They ensure continued compliance of registered products with standards of quality, safety, and efficacy throughout their life cycle.

Scope

The guideline applies to all registered medicines and vaccines seeking renewal of their marketing authorization in Kenya.

Main Content

• General and Administrative Information– documentation to be submitted, including  administrative information, QIS, proof of continued compliance with Good Manufacturing Practice (GMP), and evidence of post-marketing surveillance.
• Technical documentation requirements- offers guidance on the necessary active pharmaceutical ingredient(s), finished pharmaceutical product, clinical, and product information and labeling documentation to be submitted.
• Procedures - Guidance on submission of renewal applications, stages involved in processing of applications, and grounds for rejection of an application.

Objective

The guideline provides a transparent and consistent framework for the renewal of medicines and vaccines, ensuring that products on the Kenyan market remain safe, effective, and of assured quality, in line with international best practices.

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