These Guidelines are for the interest of the public and in particular Importers of Pharmaceuticals for Human and Veterinary use in Nigeria. It is necessary to emphasize 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.
NAFDAC will not entertain new application for the registration of imported regulated products on the Federal Government Import Prohibition List, NAFDAC Ceiling List and Banned formulations. To initiate the registration process for a drug product, the Applicant is required to submit a Dossier of the drug product for screening. (See Dossier Submission Guide). Dossier Screening clearance is a prerequisite for submission of applications for pharmaceuticals for human use.
 The Application for the registration of all drug products should be processed on the NAFDAC Automated Product Administration and Monitoring System (NAPAMS) portal – https://registration.nafdac.gov.ng. For more information see the NAPAMS User Manual. A separate application form shall be submitted for each product. See detailed guidance here
