These guidelines are for the interest of the general public and in particular pharmaceutical, herbal and cosmetics industries in Nigeria.

It is necessary to emphasize that, no drug and related products should be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of ACT CAP F33 LFN 2004 (formerly decree 19 of 1993) and the accompanying guidelines.

A manufacturer who intends to register a drug or related product in Nigeria should first have the factory inspected by the Establishment Inspection Directorate of NAFDAC and be assigned a Certificate of Recognition as a manufacturer before an application to register the product can be made.