NAFDAC Good Pharmacovigilance Practice Guidelines 2016
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines apply to all entities that have the authorization to put medicinal products into the Nigerian market. These guidelines are intended to help all stakeholders comply with the provisions of the GVP regulations. They provide detailed guidance for marketing authorization holders on establishing and maintaining a pharmacovigilance system including its quality management, pharmacovigilance system master file, adverse reaction reporting, risk management, post-authorization safety studies, risk communication and pharmacovigilance audit.
You are viewing a previous version. Click here to view the current version.
Read in full screenProcess Flow
Department of Pharmacovigilance and Post Marketing Surveillance ⬤
Office of the Director General NAFDAC ⬤
Office of the Permanent Secretary, Ministry of Health ⬤
Office of the Minister of State for Health ⬤
Office of the Minister of Health ⬤
Federal Executive Council ⬤
NAFDAC Good Pharmacovigilance Practice Guidelines 2016 Current Version
January 2022
These guidelines apply to all entities that have the authorization to put medicinal products into the Nigerian market. These guidelines are intended to help all stakeholders comply with the provisions of the GVP regulations. They provide detailed guidance for marketing authorization holders on establishing and maintaining a pharmacovigilance system including its quality management, pharmacovigilance system master file, adverse reaction reporting, risk management, post-authorization safety studies, risk communication and pharmacovigilance audit.
Thank you for requesting an expert analysis
A member of our team will review your request and reply back to the email address on file.