NAFDAC Good Pharmacovigilance Practice Guidelines 2016
Ministry of Health, National Agency for food and Drug Administration and Control
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.