The National Agency for Food, Drug, and Administration Control (NAFDAC) is in charge of overseeing and maintaining the distribution, transportation, advertisement, exportation, importation, manufacturing, and registration of products such as drugs, chemicals, consumable goods, cosmetics, biological, and medical services.
The NAFDAC’s requirements for manufacturing or importing food, drugs, or consumer goods in Nigeria vary depending on whether such items are manufactured locally or abroad.
According to the NAFDAC Act, it is illegal to market any drugs or consumable goods to the general public in Nigeria without first registering with the NAFDAC. If a company is established in Nigeria to import or manufacture food, drugs, or consumable products, all of its products must be registered with NAFDAC.
Before registering its company product with NAFDAC, a company involved in the production, manufacturing, and distribution of food, imported foods, drugs, semi-processed food, and cosmetics must register and establish a company with the Corporate Affairs Commission (CAC).
The registration of locally manufactured NAFDAC Regulated Products differs slightly from that of imported goods.
Understanding NAFDAC’s Role
NAFDAC is a powerhouse overseeing the control, distribution, advertisement, exportation, importation, manufacture, and registration of various products in Nigeria. From drugs and chemicals to consumable goods, cosmetics, biologicals, and medical services, NAFDAC ensures that products meet the necessary standards before reaching the public.
The Legal Imperative
Under the NAFDAC Act, it is a legal requirement to register any drugs or consumable goods in Nigeria before they can be marketed to the public. This applies to both locally produced and imported products.
Requirements for Locally Produced Items
Whether products are locally produced or imported, the NAFDAC requirements for producing or importing food, drugs, or consumable goods depend on their origin. Under the NAFDAC Act, it is imperative to register any drugs or consumable goods before marketing them to the public.
1. Certificate of Incorporation
Submit the Corporate Affairs Commission (CAC) certificate of incorporation to establish your company.
2. Certificate of Inspection
Include the certificate of inspection issued by NAFDAC for your product.
3. Power of Attorney
For imported products, provide the original copy of the power of attorney from the manufacturer.
4. Comprehensive Certificate of Analysis
Include a detailed certificate of analysis for the batch of the product submitted for registration.
5. Trademark Approval
Ensure trademark approval for your brand name.
6. Application to the Director
Forward a comprehensive application to the Director, stating the manufacturer’s name, brand name, and product.
7. Completed NAFDAC Application Form
Fill out the NAFDAC application form.
8. Samples for Analysis
Provide three samples of your product for quality analysis and inspection.
Requirements for Foreign Produced Items
For foreign products seeking entry into Nigeria, the NAFDAC Registration Number is crucial. Requirements include:
- Notarized Declaration filled and notarized by a Notary Public in Nigeria
- Power of Attorney or Contract Manufacturing Agreement
- Certificate of Free Sale authenticated by the Nigerian Embassy in the country of origin
- Comprehensive Certificate of Analysis
- Certificate of Business Incorporation of the Importing Company with the Corporate Affairs Commission in Nigeria
- Certificate of Registration of Brand Name with the Trademark Registry
- Application letter for Import Permit by the applicant (Local Agent)
- Duly completed Registration Form online
- Coloured Artwork/Label of the product and leaflet insert
- Evidence of GMP inspection by NAFDAC
- GMP Invitation letter from the manufacturer
How Long Does NAFDAC Registration Take?
- Food products: Not more than 90 days from the acceptance of the application.
- Drug products: Not more than 120 days from the acceptance of the application.
- Variation of product registration: Not more than 60 days.
Registration Processes With Timelines
- Submission of Application – 0 days
- Verification of Documents – 10 days
- Facility Inspection/Sampling – 10 days for Food, 20 days for Drugs
- Laboratory Analysis – 30 days for Food, 40 days for Drugs
- Final Vetting – 10 days
- Approval Meeting/Issuance of NAFDAC Registration Number – 20 days
Total number of days: 90 days for Food, 120 days for Drugs.
Conclusion
NAFDAC grants a registration number or certificate only after rigorous quality and standard tests. Successful registration empowers importers to bring in products in large quantities, provided they adhere to proper labeling to avoid unnecessary delays in the importation process.
FAQs About NAFDAC Registration
- Is NAFDAC registration mandatory for all products?
- Yes, according to the NAFDAC Act, any product for public consumption must be registered.
- What happens if my product fails the quality and standard test?
- If your product fails, necessary adjustments must be made before reapplying for registration.
- Can I import products without a NAFDAC registration number?
- No, all imported products must have a NAFDAC registration number.
- How often should imported products be inspected by NAFDAC?
- Inspection frequency may vary, but adherence to quality standards is crucial.
- Can I start importing products after obtaining the registration number?
- Yes, upon successful registration, products can be imported, ensuring proper labeling.
