If you want to sell any product people will consume, by taking it orally or applying it on their body, you must get NAFDAC approval. With it, your product is illegal if it hits the market.
The proof that you have approval from NAFDAC is your NAFDAC number. Contrary to what some manufacturers presume, getting NAFDAC number – and the entire NAFDAC product registration process – isn’t overly complex.
It may be rigorous but it’s nothing you can’t work out with the right information and by following due process. In this post, I’ll explain how to get NAFDAC number in Nigeria.
NAFDAC is a Nigerian federal agency that regulates food and drugs, under the Federal Ministry of Health. NAFDAC regulates the manufacture, import, export, distribution, advertisement, sale, and usage of food, drugs, cosmetics, medical devices, packaged water, chemicals, and detergents.
The 1988 World Health Assembly asked countries to assist combat counterfeit medications globally, which led to NAFDAC.
NAFDAC was created by Decree No. 15 of 1993 (January 1993) as revised by Decree No. 19 of 1999. However, the agency became a “Federal Ministry of Health parastatal” on January 1, 1994, and replaced the ineffectual Directorate of Food and Drug Administration and Control.
NAFDAC currently has offices in Abuja and Lagos.
NAFDAC Registration Procedure
NAFDAC registration involves just six major steps:
- You sign up on the NAFDAC website.
- You log in to the application portal.
- You complete the online application.
- You make payment for the application fee.
- You wait for your application to process.
- You get your NAFDAC certificate containing your NAFDAC number – if your application is approved.
That’s all. However, as you’d expect, each of the six steps also has sub-steps. Nevertheless, I’ll break them down.
Step 1: Signing Up
When you visit the NAFDAC website (www.nafdac.gov.ng), you’ll find a button asking you to “Register Here.” The registration process isn’t much different from that of other online platforms that you sign up for. However, you do have to provide a bulk of details as you’re not only registering, but you’re also creating a company profile with NAFDAC.
You’ll have to provide details like your company name, company type, TIN, RC number, address, phone number, email, and details of the company representative. If you’re producing a drug, you’ll have to provide your pharmacist license to practice. In addition, all applicants must upload their COI, among other relevant documents.
With all of these, it’s clear-cut that you can’t register a product with NAFDAC as an individual. You must be an incorporated company.
Step 2: Accessing The Application Portal
This step is straightforward. Simply visit the NAFDAC website, click on “Sign in,” and enter your email address and password. However, from this point, it gets a little bit intricate in terms of the details.
There’s a large variety of food and drug products that you may want to produce. If you’re making a food product, it could be solid or liquid. It could be for human or animal consumption. It could be for adult or children’s consumption.
If you’re making drugs, it could be to treat any part of the body. It could be taken orally, through the eye or ear (like drops), or applied on the skin.
Each of these different types of food and drug items have different application procedures. For some, you must seek pre-production approval via a written letter. You should check the official NAFDAC Guidelines for the specific procedure that applies to your type of product.
Step 3: Completing Your Applying
Irrespective of the application procedure you’re to take, you must complete it and provide all required documents for processing.
You’re to provide a quality information summary, product dossier, and summary of product characteristics, among others. Forms you’ll fill and submit include, but aren’t limited to, the NAFDAC BCS biowaiver, GMP compliance, CEP, and APIMF forms.
It’s important to note that the above isn’t exhaustive. The particular forms and documents you’ll submit to NAFDAC will depend on your type of product.
Step 4: Payment Of The Application Fee
Without paying your application fee, NAFDAC won’t process your registration request. Similar to supporting documents, the amount and different fees you’ll pay will depend on your type of product. You can check the NAFDAC Tariff Document to confirm the amount you are to pay. You’ll get instructions on how to pay from your application portal.
Step 5: Processing Stage
After submitting your supporting document and paying your processing fees, NAFDAC will begin processing your application. How long it takes will depend on your product type. Here’s a rundown of the processing times:
- Submission of Application: 0 days.
- Document Verification: 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(Certificate of registration): 20 days.
Therefore, in total, it’s about 90 days for Food and 120 days for Drugs. In other words, you will have to wait between three to four months after completing your application to get feedback.
Step 6: Getting Approval
If after processing your product meets all NAFDAC standards, the regulatory body will issue you a certificate. The certificate will contain your NAFDAC number – among other details – which you can now add to your products when you manufacture them.
Note that the NAFDAC registration number should be used exclusively for the product it was issued for. Using it for previously produced or subsequent products is against the law.