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 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.
Process 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 ⬤
Contacts
Fraden Bitrus
Deputy Director i/c
National Agency for Food and Drug Administration and Control (NAFDAC)
Moji Adeyeye
Director General
National Agency for Food and Drug Administration and Control (NAFDAC)
Mahmuda Mamman
Permanent Secretary
Ministry of Health
Adeleke O. Mamora
Honourable Minister of State
Ministry of Health
Osagie Ehanire
Honourable Minister
Ministry of Health
Muhammadu Buhari
President of the Federal Republic of Nigeria
NAFDAC Good Pharmacovigilance PrActice Guidelines 2016 Current Version
January 2022
These guidelines apply to all entities that have 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.
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