The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water.
NAFDAC Permits cover two categories namely:
If a manufactured or imported goods fall within any of these two categories registration with the NAFDAC is important. Where the product is a foreign product, a power of attorney duly executed for a Nigerian representative of such product registered from the manufacturer and signed by the Company’s Managing Director, Chairman or President, authorizing the Nigerian agent to act in such capacity is required.
The registration process for NAFDAC Permit is in two general stages:
Application for Approval to Bring in Samples
For the purpose of registration, a foreign company needs to put forth samples of its product for inspection. However, this is impossible without proper approval to bring such samples into the shores of Nigeria. For this, NAFDAC grants special written authorization or import permit to enable importers to bring the samples of their products. Also, documents required for clearing and taking delivery of samples must be obtained from the Manufacturer and other appropriate bodies in the country of origin.
Application for Full Registration of Samples
First and foremost, an application form is required for each product as NAFDAC approval is granted for each specific product. After filling, this form is to be submitted to the registration division of NAFDAC agency.
The key requirements for the registration process are as follows:
The general requirements for the registration on either of the stages of the permit include the following:
However, it is worthy of note that the registration of a product does not automatically confer Advertising permit. A separate approval by the Agency shall be required if the product is to be advertised.
Once the registration process is concluded, NAFDAC would assign a unique number to all the registered products. The registration is usually valid for a period of 5 years and it must be renewed before the licensee can maintain the usage. Although how to renew NAFDAC permit also involves some documentation and payment of prescribed fee, but this is not as significant as filing a new application
Finally, the NAFDAC process can be concluded within one month to 3 months depending on how swift a company seeking registration is able to put its documents together for submission. The failure to obtain a NAFDAC approval or registration before distributing any drugs or processed food or food materials may lead to a complete seizure of such products by the government.
Written by Corporate & Commercial Law Department at Resolution Law Firm, Nigeria
NOTE: Resolution Law Firm assists and represents both Local and International clients for processing of NAFDAC Registration and Import Permit in Nigeria. The Firm can be contacted using the above details.