NLIPW Trademarks Law Volume 1 Number 8
(Product Registration with NAFDAC)
The National Agency for Food and Drug Administration and Control (NAFDAC) is Nigeria’s equivalent of the U.S. Food and Drug Administration (FDA). NAFDAC is charged to protect the public health in Nigeria by assuring the safety of food, drugs, vaccines, medical devices, cosmetics, chemicals and pesticides, veterinary products, agrochemicals, herbal preparations and related products in Nigeria. In order for any business to legitimately manufacture and/or import food or drugs for trade in Nigeria, it must register its products with NAFDAC.
What is a NAFDAC registration number and how long is it valid?
A NAFDAC number is a unique number that is assigned by NAFDAC to a food or drug product that has been registered and approved for public distribution in Nigeria. This number is the consumers initial point of reference in determining whether or not a food or drug has been approved for distribution in Nigeria. The registration number is generally valid for five years but must be renewed in order to be maintained.
How long does it take to obtain a NAFDAC registration number?
The processing time for obtaining a NAFDAC registration number usually lasts between two months to two years depending on individual cases.
Briefly describe the application process.
The first step is the application for approval to procure samples into Nigeria: This step only applies in cases where the product is manufactured outside Nigeria. Because NAFDAC requires samples of the product as part of its examination process, a foreign company applying for a NAFDAC number must obtain a special authorization to import such samples. The application to bring in the samples must be made through a Nigerian-based representative of the foreign manufacturer who must provide proof of his authority to act on behalf of the manufacturer i.e. a Power of Attorney issued by the manufacturer. The company must also send a Certificate of Analysis issued by the manufacturer and Certificate of Manufacture and Free Sale issued by the appropriate regulatory authority in the country of origin.
The next step is for the applicant to submit the application form (for drug registration it is Form D-REG/001) for each product i.e. it is a single product application process.
- Next all products that are to be registered must be submitted for vetting. In addition, the applicant must submit a copy of the permit to import samples, five (5) copies of the product dossier, a letter of invitation to NAFDAC to inspect the factory outside of Nigeria, a comprehensive certificate of product analysis, three (3) packs as vetting samples that must conform to NAFDAC’s product labeling regulations, a certificate of manufacture issued by the competent health or regulatory authority in the country of origin and authenticated by the Nigerian Mission in that country (if it is a foreign import) and a certificate of registration of brand name with trademark registry in Nigeria.
- Next is the examination and laboratory analysis stage: 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.
- Next: product approval: During this step, the product together with all the documents mentioned above will pass through a series of approval meetings at the end of which a NAFDAC Registration number is assigned if everything is found to be satisfactory.
This article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances.