How to get a NAFDAC registration number for your product

Who needs NAFDAC registration

Under the NAFDAC Act, NAFDAC registers food, drugs, cosmetics, medical devices, bottled water and chemicals. Its guidelines are direct: no drug, and no regulated pre-packaged food, may be made, imported, exported, advertised, sold, distributed or used in Nigeria unless it is registered.

Each product needs its own application. NAFDAC's guidelines say a separate application form is submitted for each product.

NAFDAC publishes separate guidelines for each category on its guidelines page, including drugs made in Nigeria, pre-packaged food made in Nigeria, cosmetics, and herbal medicines and dietary supplements. Read the one for your product first. The steps below come from the drug and food guidelines.

Documents to prepare

You upload these on the portal. For pre-packaged food made in Nigeria, NAFDAC asks for:

• An application letter on your company letterhead, addressed to the Director-General of NAFDAC
• Evidence of business incorporation
• Your batch formulation, where it applies
• Evidence of payment
• A contract manufacturing agreement, if another company makes the product for you
• Evidence that your brand name is registered with the Trademark Registry in the Ministry of Industry, Trade and Investment, in the name of the brand owner
• Product labels or coloured artwork, in line with the Pre-packaged Food (Labelling) Regulations 2022
• Comprehensive certificates of analysis for the product

For drugs made in Nigeria, the list adds evidence of incorporation with the Corporate Affairs Commission (CAC), trademark registration in Class 5, the annual licence of your Superintendent Pharmacist, a Premises Retention Licence for the facility, and evidence of a satisfactory inspection or a GMP certificate. You also submit a product dossier for screening first, and NAFDAC may ask to see your original documents. For drugs for human use, dossier clearance comes before the application.

What your label needs

NAFDAC reviews your label as part of the application. For drugs made in Nigeria, the guidelines list these minimum label details:

• The generic name, and the brand name where you use one. The generic name must be clearly visible, directly under the brand name.
• The manufacturer's name and full address
• Space for the NAFDAC Registration Number
• Batch number, manufacturing date and expiry date
• Dosage form and strength, and the amount of each active ingredient per dose
• Net content, storage conditions and any warnings
• A patient information leaflet

NAFDAC will not consider a drug whose name or label closely resembles a product already registered. A label in a foreign language needs an English translation. For generic drugs, you submit a bioequivalence study or biowaiver data.

The registration process, step by step

Applications go through NAPAMS, the NAFDAC Automated Product Administration and Monitoring System, at registration.nafdac.gov.ng. The stages below follow the portal and NAFDAC's product registration page.

1. Create an account. On registration.nafdac.gov.ng, select Login, choose Login as a Client, and select Register as a New Client.
2. Sign in and complete an application for each product. Upload your documents.
3. Pay the fees on the portal. NAFDAC sets the amounts in its tariff.
4. NAFDAC verifies your documents.
5. NAFDAC inspects your facility and takes samples. Submit product samples when NAFDAC asks for them.
6. NAFDAC's laboratory analyses the samples.
7. Your application goes through final vetting and an approval meeting. For drugs, this is the Food and Drug Registration Committee.
8. NAFDAC issues a Certificate of Registration with your NAFDAC Registration Number. For drugs, the certificate is electronic.

To follow your application, open Applications on the portal and select Submitted Applications. For portal problems, NAFDAC asks you to email [email protected].

If NAFDAC finds a gap, it issues a compliance directive. The product registration page asks you to comply within 7 working days. The drug and food guidelines say an application is closed if you do not respond within 90 working days. Delays caused by the applicant do not count towards NAFDAC's timelines.

How long it takes

For drugs, NAFDAC gives 240 working days from acceptance of your application to the registration number. The product registration page splits this into 40 days for document verification, 50 for inspection and sampling, 60 for laboratory analysis, 68 for final vetting and 22 for the approval meeting and certificate.

For food, NAFDAC's documents give different figures. The product registration page lists 90 working days. The pre-packaged food guidelines effective from March 2026 give 180 working days. Ask the Food Registration and Regulatory Affairs Directorate which applies to your product.

NAFDAC's guidelines say that filing an application or paying the fee does not give a product registration status. Only the certificate does.

After you get your NAFDAC number

• Under the drug and food guidelines, a Certificate of Registration lasts five years. For food, a listing registration lasts two years.
• For food, you can start a renewal six months before the certificate expires.
• Print the NAFDAC Registration Number on your label. NAFDAC's drug labelling guidelines list it among the minimum label details, with the batch number, manufacturing date and expiry date.
• Registration does not include permission to advertise. Advertising needs a separate application and approval.
• NAFDAC can revoke, suspend or vary a certificate while it is valid.
• Submit your product information for the NAFDAC Greenbook. NAFDAC has asked marketing authorisation holders to do this.

Your NAFDAC number can be copied

A NAFDAC number is printed on every pack, and counterfeiters copy it. In Public Alert No. 023/2026, NAFDAC warned of counterfeit proguanil tablets carrying the registration number of Feroglobin B12 capsules from Vitabiotics Nigeria.

With Batach, you can protect your product with anti-counterfeiting methods that anyone can verify with a phone at batach.io/scan. Read more in how to protect your product from counterfeiters.

Who to contact at NAFDAC

• Drug registration: [email protected]
• Food registration: [email protected]
• NAPAMS portal problems: [email protected]
• General enquiries: 0700-1-NAFDAC (0700-1-623322)

NAFDAC's Drug and Food Registration Directorates are at the NAFDAC Office Complex, Isolo Industrial Estate, Apapa-Oshodi Expressway, Isolo, Lagos. NAFDAC's headquarters are at Plot 2032, Olusegun Obasanjo Way, Zone 7, Wuse, Abuja.