NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs)
Ministry of Industry, Trade and Investment, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines are for the interest of the general public and in particular importers of Pharmaceutical and Veterinary drugs in Nigeria. The document emphasizes that no drug shall be manufactured, imported, exported, advertised, sold distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislations and the accompanying guidelines. It outlines the guidelines for application for registration of the imported drug, import permits, submission of samples for laboratory analysis and labelling of imported drugs.
Process Flow
Department of Registration and Regulatory Affairs ⬤
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 Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs) Current Version
January 2022
These guidelines are for the interest of the general public and in particular importers of Pharmaceutical and Veterinary drugs in Nigeria. The document emphasizes that no drug shall be manufactured, imported, exported, advertised, sold distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislations and the accompanying guidelines. It outlines the guidelines for application for registration of the imported drug, import permits, submission of samples for laboratory analysis and labelling of imported drugs.
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