The requirements set by National Agency for Food and Drug Administration and Control (NAFDAC) for production or importation of food, drugs or consumable goods in Nigeria depends on the location of production (whether such items are produced locally or abroad).
Under the law establishing the NAFDAC, it is unlawful and illegal to market any drugs or consumable goods in Nigeria without due registration and authorisation.
If any company is set up in Nigeria for the purpose of the importation or manufacturing of food or drugs or consumable products, all the products produced by such a company must be registered with the NAFDAC.
Documentary Requirements for NAFDAC Registration/Import License
The registration process for NAFDAC Permit is in two general stages:
- Application for approval to bring in samples – applicable to goods manufactured outside Nigeria.
- Application for full registration of product – applies whether the goods are locally manufactured or imported
Application for Approval to Bring in Samples (Import License)
For this, NAFDAC grants 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 (NAFDAC Registration)
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 general requirements for the registration on either of the stages of the permit include the following:
- A written application for product registration shall be made to the Director (Registration and Regulatory Affairs) stating the name of the manufacturer, the generic name (and brand name, if applicable) of product, product strength and indications.
- The applicant should obtain and fill the prescribed NAFDAC application form (Form D-REG/001).
- Certificate of Incorporation issued by the Corporate Affairs Commission.
- Comprehensive Certificate of analysis of the batch of the product for registration from the manufacturer stating name and signature of the analyst.
- Packs of the products samples.
- Evidence of pre-product inspection or Certificate of Recognition issued by NAFDAC.
- Notarized original copy of the duly executed Power of Attorney from the product manufacturer (imported product).
- 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 foreign import). Where there is no Nigerian mission, the British High Commission or an ECOWAS country Mission will authenticate.
- If contract-manufactured, Contract Manufacturing Agreement, properly executed and notarized by a Notary Public in the country of manufacture.
- Warehouse acquisition or premises acquisition(where applicable).
- Certificate of Trademark Registration of brand name with trademark registry in the Ministry of Commerce here in Nigeria.
- Letter of invitation from manufacturer to the Director General of the NAFDAC to inspect factory abroad, stating full name and location of the plant.
- Informative, clear and accurate labelling of the products.
- Payment of the prescribed fee.
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.
Cost of NAFDAC Registration and Import License
The cost of procuring and Import License and/or NAFDAC Registration varies and is dependent on the type of product.
If you’re interested in procuring NAFDAC Registration for your product, we can help you outline the fees and handle the process.