NAFDAC Guidelines for Importation and Release of Investigational Medicinal Products
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
Investigational medicinal products, which are unregistered medicines, can only be brought into the country after a positive ethical opinion is obtained, the clinical trial application has been approved and a letter of authorization has been issued by NAFDAC. Therefore, this guideline applies to all investigational medicinal products, including vaccines, which do not have marketing authorization in the country of intended use. It provides information on the responsibilities of the sponsor, labelling and packaging, importation and documentation procedures.
Process Flow
Department of Investigation & Enforcement ⬤
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 for health ⬤
Federal Executive Council ⬤
NAFDAC Guidelines for Importation and Release of Investigational Medicinal Products Current Version
January 2022
Investigational medicinal products, which are unregistered medicines, can only be brought into the country after a positive ethical opinion is obtained, the clinical trial application has been approved and a letter of authorization has been issued by NAFDAC. Therefore, this guideline applies to all investigational medicinal products, including vaccines, which do not have marketing authorization in the country of intended use. It provides information on the responsibilities of the sponsor, labelling and packaging, importation and documentation procedures.
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