The National Agency for Food and Drug Administration and Control, NAFDAC is the body in Nigeria charged with the registration of food and drugs in Nigeria. This registration in effect grants marketing authorization to the licence holder.
For the first timer however, this process of granting marketing authorization by registration of the products presents as insurmountable consisting primarily of endless requests for information and supporting documents from various countries.
The ill-equiped applicant goes back and forth for months or sometimes years only to be asked for more data. However the Agency maintains a stringent process because of the very chaotic distribution network in Nigeria.Once an application is succesfull, people usually want to obtain marketing authorisation for more products.
How to add a product to a NAFDAC Registration Certificate
A Registration Certificate is for one product only as a unique number is ascribed to it on completion of processing. However, if you intend to market the same product in different pack sizes or as variants (ie with different flavours or odours, a permit for additional pack size or a fresh registration must be processed.
The decision as to whether the new product can be considered a variant or must be freshly registered resides with NAFDAC, however the following are important to know.
Registration as a fresh product in any of the following cases
- Change in an active ingredient (paracetamol tablets will have a different number from a tablet containing paracetamol and caffeine)
- Change in concentration of active ingredient (clobetasol 1% cream will have a different number from 2% cream)
- Change in formulation (paracetamol syrup and tablets have different numbers)
Processing approval for additional pack size
- The product contains the same active ingredient in the same concentration and same formulation but a different volume (paracetamol 5% syrup – 50ml and 70ml)
- The product contains the same active ingredient in the same concentration and same formulation but a different pack size (paracetamol 500mg 100’s and 200’s)
Processing approval for variants (this must be vetted by NAFDAC before approval)
- The same product and same active ingredient but a different flavour (orange lozenges vs lemon lozenges)
- The same active ingredient but different odoriferous substance (anti-perspirant – with different perfumes)
Adding a product to a NAFDAC Registration Certificate, in essence having more than one presentation of a product with the same NAFDAC number, can only happen after the application has been duly scrutinised by NAFDAC to ensure that the products are basically the same scientifically and physically and the necessary fees paid. In all other situations a fresh registration will have to be processed.
Source
NAFDAC www.nafdac.gov.ng
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