The National Agency for Food and Drug Administration Control which was established by Decree 15 of 1993, is the agency in charge of regulating and controlling the manufacturing, importation, exportation, distribution, advertisement, sale, and use of foods, drugs, cosmetics, chemicals, medical devices and packaged water. Before any item that falls under Drugs and Foods are imported into Nigeria, there are some prerequisites that must be met.
Decree No. 15 of 1993 was amended by Decree No. 19 of 1999 and is now the National Agency for Food and Drug Administration and Control Act Cap N1 LFN 2004.
WHAT ARE FOOD SUPPLEMENTS
Food Supplements are sources of nutrients that are in concentrated form. This includes concentrated levels of minerals, vitamins or some other sources that have nutritional or physiological effects. There are several ingredients which can be seen to be present in different kinds of food supplements, including, but not limited to amino acids, fatty acids, herbal extracts, minerals and vitamins.
The end goal of creating food supplements is to correct nutritional imbalances and lopsidedness. They are not drugs and are not used to treat or prevent diseases in humans. Their purposes are tilted towards the possible prevention of these diseases by infusing appropriate amounts of nutrients in the body. Food supplements can be packaged in the form of pills, capsules, or liquid.
IMPORTING FOOD SUPPLEMENTS INTO NIGERIA
- APPLICATION STAGE
The first thing to note is that importing food supplements into Nigeria without recourse to the regulatory framework of the National Agency for Food and Drug Control amounts to a direct contravention of the law. Food supplements in Nigeria are classified under Herbal Remedies/Dietary supplements. No Food supplement can be manufactured, imported, exported, sold, or even advertised in Nigeria unless it has been registered and approved by the National Agency for Food and Drug Control (NAFDAC).
An application equally has to be made to the Director-General of NAFDAC containing the generic name of the product, and the brand name. It is imperative to note that the brand names of each of the products intended to be registered with NAFDAC have to be trademarked. An online application form has to equally be purchased for each of the products intended to be registered.
- DOCUMENTATION STAGE
There are several documents which are required to be vetted by NAFDAC. A notarized declaration has to be submitted to NAFDAC. Where the manufacturer is outside Nigeria, the manufacturer has to execute a Power of Attorney in his home country. This Power of Attorney is to enable the declarant to undertake the registration of the food supplements here in Nigeria. The Power of Attorney has to state the names of the products to be registered. This Power of Attorney has to be notarized by a Notary Public in the Country of declaration too. However, where the applicant is the owner of the product, he has to prepare a Contract Manufacturing Agreement and sign it by himself.
A Certificate of Manufacture and Free Sale has to be presented to NAFDAC too. In this certificate, the Manufacturer is to show evidence that he is licensed to produce that product in his home country, and that the production of that food supplement is not a contravention of the Law. The Certificate of Free Sale has to be issued by the Health Regulatory Body in that jurisdiction, it has to include the name of the products, and has to be authenticated by the Nigerian Embassy in that jurisdiction. In the event that there is no Nigerian Embassy in that jurisdiction, any ECOWAS or Commonwealth country's authentication would suffice.
The Applicant also has to submit a Certificate of analysis. This certificate of analysis must be presented on the Letter-head paper of the laboratory where the analysis took place. It has to contain brand name, batch number, manufacturing and expiry dates of the product(s), and the name and designation of the analyst in question. This has to be accompanied by a coloured leaflet of the product(s) intended to be registered.
The Importing Company has to incorporate a local company in Nigeria and evidence of the incorporation has to be shown, and the evidence of the trademarking of all the brand names of the products equally has to be shown.
Usually, NAFDAC goes to inspect the laboratory where the products were manufactured, and thus, the applicant must send a letter of invitation to NAFDAC, inviting them to inspect the product. After all the supporting documents have been successfully checked and screened, NAFDAC would issue an Import Permit, after which all the products will be submitted for vetting.
- POST DOCUMENTARY STAGE
There are costs at this stage which would have to be borne by the applicant. Applicants will be informed about the costs by the agency as they proceed with the registration. To have an idea of the cost implications, the official NAFDAC website can be checked.
Tariff costs are usually dependent on whether or not the products were manufactured in an ECOWAS country or not. Applicants have to consult NAFDAC officials to be sure about the amount of Tariff which will apply to them.
Laboratory analysis will be conducted by NAFDAC, and for products which are approved, a notification of registration or listing will be issued to the applicant, while for products not approved, a compliance directive will be issued. Successful applicants will eventually be given a Certificate of Registration, which can be valid for five (5) years or two (2) years, depending on the product(s) in question.
It is important to note that registering a food supplement product does not in any way confer an advertising permit. A separate application has to be made to NAFDAC, which will in turn elect to approve or disapprove as to whether the product can be advertised. It is also important to note that the filing fees paid for application forms do not automatically confer registration status as NAFDAC reserves the right to reject any application for valid reasons.
For the manufacturing of any food supplement, regard has to be made to the regulatory authority of the National Agency for Food and Drug Control.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.