Adding a Product to a NAFDAC Registration Certificate — Before a food or drug product can be manufactured, imported, exported, advertised, sold or distributed in Nigeria, it must be registered with the National Agency for Food and Drug Administration and Control (NAFDAC), which is the agency in Nigeria responsible for the registration of food and drugs products.
Generally, a Registration Certificate issued by NAFDAC is for one product only. This is because a unique number is ascribed to each certificate on successful completion of the evaluation process. However, manufacturers who intend to market the same product in different pack sizes or as variants must apply to the NAFDAC for permits for pack size extension. NAFDAC will scrutinize the application in order to determine whether or not the products active ingredients are the same scientifically and physically.
Under what circumstances must you register a product as a fresh product?
If there is a change in the active ingredient, then you must register the product as a fresh product with the NAFDAC. Again, if there is a change in concentration of the active ingredient or change in formulation, you must register the product as a fresh product with the NAFDAC.
Where there is a change in the primary package of a product, is a fresh application for registration of the product required by the NAFDAC?
No, a fresh application to the NAFDAC is not required. However, where there is a change in the primary package of a product requiring size extension, a laboratory evaluation by the NAFDAC is usually conducted to ensure that the product quality is not compromised but this does not amount to a fresh registration application.
This means that if the product contains the same active ingredient in the same concentration but in different volumes or pack size, a new application for registration is not required but the manufacturer must seek approval from the NAFDAC for the additional pack size.
What happens in cases where the new product contains the same active ingredient as a previously registered product but there is a variant i.e. different flavors or odours?
In cases like this, a new registration will be required and as such, an application must be made to the NAFDAC for approval of the new flavor.
This article is intended to provide general information about the subject matter – Adding a Product to a NAFDAC Registration Certificate. Professional legal advice should be sought about specific circumstances.