The National Agency for Food and Drug Administration and Control (NAFDAC) is the equivalent in Nigeria of the US FDA. Established by Decree 15 of 1993 as amended by Decree 19 of 1999 and now Cap N1 of the Laws of the Federation of Nigeria (LFN) 2004.
NAFDAC undertakes registration of food, drugs, medical devices, cosmetics, agrochemicals and other similar products in Nigeria. At the end of the process, a registration number is given to the product and a registration certificate is issued to the applicant.
NAFDAC registers products to give marketing authorisation and boost consumer confidence. This registration process is essential before sales and distribution of NAFDAC regulated products in Nigeria.
NAFDAC Registration Number
This is a unique number assigned to a particular product by NAFDAC in Nigeria. This effectively grants the holder of the registration certificate marketing authorization. This number when affixed on a product confers consumer confidence in the quality/efficacy of the product. The registration number which consists of a prefix and a suffix is maintained by the product as long as the registration is renewed on expiration.
Validity of NAFDAC Registration in Nigeria
The full product registration usually remains valid for five (5) years. However for certain reasons a product may be listed which has a validity of 2 years. The reasons for listing include insufficient data on the product, herbal formulations and drugs on which local clinical trials have not been conducted.
NAFDAC Registration Process
The Registration process is considered a cumbersome procedure by all applicants. In theory, it should take two months. In reality however some registrations have gone on for more than a year. The challenge is usually documentation. A careful consideration of all the documentation requirements and an effort to obtain the documents before the initial application for Registration will make the process easier.
Steps to be taken
Step 1 – Documentation
The documents required include Power Of Attorney, Certificate of Manufacture and Free Sale or Certificate of Pharmaceutical Product, Comprehensive Certificate of Product Analysis, Certificate of Business Incorporation, Certificate of Registration of Brand Name/ Trademark, Completed Application Form, Application Letter for Import Permit.
Step 2 – Import Permit
The import permit authorizes the applicant to import samples for registration.
Step 3 – Product Vetting
The products to be registered are submitted for vetting with the following documents: letter of invitation to inspect the factory, copy of the permit to import samples and receipt of payment for the permit, certificate of analysis and three well labelled vetting samples.
Step 4 – Laboratory Analysis
The products are submitted for analysis once they have been successfully vetted, accompanied by proof of receipt of vetting samples and the payment of the necessary charges.
Step 5 – Product Approval
The product with all the documents passes through a series of approval meetings at the end of which a NAFDAC Registration number is assigned to it.
Product registration by NAFDAC in Nigeria ensures that genuine importers are issued NAFDAC Registration numbers for their products which in turn enhances consumer confidence. The process need not be confusing or frustrating
Breakdown of Statutory Fees
The fees to be paid are processing fees and fees for the issuance of the registration certificate. The processing fee is made up of charges for the issuance of permits to import registration samples and charges for laboratory analysis.
Payable fees vary according to the category of products.