June 27, 2023,
Dear Esteemed Client,
This is to inform all Certificate of Product Registration Holders for human medicines that NAFDAC has developed a Guideline for the preparation of Summary of Product Characteristics (SmPC). The NAFDAC Drugs and Related Products Registration Regulations and NAFDAC Drugs and Related Products Labelling Regulations require that drug product registration application include labelling information in accordance with extant provisions prescribed in the respective regulations. Summary of Product Characteristics (SmPC) forms an intrinsic and integral part of product information provided in drug registration application for the regulatory authority and healthcare professionals.
As a result, all Certificate of Product Registration Holders for human medicines would be required to develop SmPCs in compliance to the Guidelines for the preparation of Summary of Product Characteristics (SmPC) for all drug products. The SmPC would be uploaded as part of documentation requirement for product registration and must be updated throughout the life cycle of the product as new data emerge, however changes are only made upon approval by NAFDAC.
The Guidelines for Summary of Product Characteristics (SmPC) is available in the link below or visit the NAFDAC website for Guidelines for the Preparation of Summary of Product Characteristics (SmPC) for drug products in Nigeria.
Please take note for compliance.
NAFDAC…Customer focused; Agency minded