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Guideline on Summary of Product Characteristics, Patient Information Leaflet and Labelling

Issued by the Pharmacy and Poisons Board (PPB), this guideline provides requirements for the format, content, and presentation of product information materials. It ensures that Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs),  and labeling are scientifically accurate, consistent, and user-friendly to support safe and effective use of medicines in Kenya.

Scope

This guideline applies to all medicines and health products requiring approved SmPC, PIL, and labeling as part of registration or renewal applications.

Main Content

• Summary of Product Characteristics (SmPC)– outlines the structure and format of the technical reference for healthcare professionals, covering indications, dosage, contraindications, warnings, pharmacology, and storage.
• Patient Information Leaflet (PIL)– outlines the structure and format of the plain-language guidance for patients, ensuring clarity, readability, and usability.
• Labelling Requirements– outlines the mandatory information to be included in the primary and secondarypackaging.

Objective

To provide a clear and consistent framework that guarantees healthcare professionals and patients have access to accurate, comprehensive, and accessible product information, thereby strengthening rational use and patient safety.

Attached Files