Starting a food or drug-related business in Nigeria comes with a few challenges, one of which is NAFDAC registration. Many business owners shy away from it, thinking it’s overly complicated or costly. Others, unfortunately, try to bypass it, hoping to save time or money. But if you’re serious about growing a legitimate business in this space, NAFDAC certification isn’t something you can skip.
In fact, not getting NAFDAC certification could lead to massive set back in your business: Like fines, your products being confiscated, or even having your business shut down entirely. Not to mention, consumers won’t trust a brand without that little NAFDAC number on the package.
But don’t stress out yet! Yes, the process involves a few steps, but I’m here to break it down for you in a way that’s easy to understand and, most importantly, doable.
Why Do You Need NAFDAC Certification?
The National Agency for Food and Drug Administration and Control (NAFDAC) was set up to make sure that the food, drugs, and other consumables we use daily in Nigeria are safe. Unfortunately, there’s a long history of fake drugs and substandard products circulating in the country, which led to severe public health issues. The tipping point came in 1990 when over 100 children died after taking contaminated paracetamol syrup. This event prompted the creation of NAFDAC in 1992.
Since then, NAFDAC has been the gatekeeper, ensuring that the consumables produced, imported, or distributed in Nigeria meet safety and quality standards. So, if you’re selling anything that falls into these categories, NAFDAC registration isn’t just a requirement—it’s a way to build trust with your customers and protect them from harm.
Step-by-Step Guide to NAFDAC Registration for Your Business
Let’s get into the process and what you need to get started:
1. Prepare the Required Documents
Before you even think about starting the NAFDAC registration process, you need to gather some important documents. The type of documents you need will depend on whether your business is micro-scale, small-scale, or larger. But in any case, here’s a breakdown:
For Micro-Scale Businesses:
- CAC Registration: Make sure your business is officially registered with the Corporate Affairs Commission (CAC). Without this, you can’t proceed with NAFDAC registration.
- Site Use Agreement: If you don’t own the space where your product is manufactured, you’ll need an agreement that allows you to use the site.
- Trademark Approval: It’s not a must, but it’s strongly recommended. If you want to protect your brand identity, getting your trademark approved is a good move.
- Product Samples & Labels: Submit at least three labels of your product and a sample for evaluation.
- Fumigation Certificate: This proves that your production space is pest-free, which is a crucial part of NAFDAC’s Good Hygiene Practices (GHP).
- Health Certificates for Production Staff: This is where things get a bit technical. Every staff member involved in handling your products must undergo basic health checks (sputum, stool, urine, Hepatitis B, Widal tests) to ensure they’re fit for the job. Their medical fitness certificates must be part of your submission.
For Small-Scale Businesses:
You’ll need everything listed above for micro-scale businesses, plus a few more documents:
- Standard Operating Procedures (SOPs): NAFDAC needs to see detailed written instructions on how you manage quality assurance, how you clean your equipment, and how you handle packaging materials.
- Certificates of Analysis: This applies to both your raw materials and your finished products. It’s a way of proving that everything you use—and everything you sell—meets NAFDAC standards.
Once you have all these documents in hand, you’re ready to start the actual application.
2. Getting the NAFDAC Registration Form
This part is Simple. Go to the NAFDAC website and download the registration form and guidelines. You can also visit any NAFDAC state office if you prefer to pick up the form in person.
3. Submitting Your Documents
When submitting, make sure you include all the following documents:
- Evidence of your CAC Registration.
- Your Site Use Agreement, if applicable.
- Trademark Approval (recommended but not compulsory).
- A sample of your product and three labels for evaluation.
- A Fumigation Certificate.
- The Health Certificates of your production staff.
At this point, it’s a good idea to request payment advice from a NAFDAC desk officer to know exactly how much you’ll be paying. NAFDAC fees depend on your product and scale, so getting the payment details right is crucial.
You’ll make your payment through Remita, and NAFDAC’s Accounts Department will give you the receipt. Make sure you Hold on to that— you’ll need it later!
4. Facility Inspection & Sampling
Once you’ve submitted your documents and made the necessary payments, NAFDAC will schedule an inspection of your production facility. This is the most important part because they’ll check if you’re adhering to Good Manufacturing Practices (GMP) and Good Hygiene Practices (GHP). These practices ensure your facility is clean, safe, and efficient.
During the inspection, NAFDAC will also collect product samples for laboratory testing. If your facility passes the inspection and your samples meet their standards, you’re almost at the finish line!
5. Product Approval and Certification
After your product passes both the facility inspection and laboratory analysis, NAFDAC will notify you that your registration certificate is ready for collection. From the time you submit your documents, the entire process usually takes about 90 working days.
It’s important to remember that this isn’t just a formality—getting NAFDAC certification shows that your products are safe and meet Nigeria’s standards for quality and consumer protection.
What Should Be On Your Product Label?
NAFDAC takes labeling seriously and for a good reason. Your product label isn’t just about branding—it’s about giving consumers the information they need. Here’s what your label needs to include:
- The product name, net weight/volume, and batch number.
- The manufacturing and best-before dates.
- A space for the NAFDAC registration number.
- Allergy cautions, if necessary.
- Storage conditions, ingredient list, and your company’s details.
Getting these details right on your label is crucial, as NAFDAC won’t approve your product without it.
NAFDAC Registration Fees
Let’s talk money. The fees you’ll need to pay depend on your product and the services required. Here’s a quick look at some of the common fees:
- Single Product Registration: ₦15,000
- Product Variants (per medium or concept): ₦5,000
- 2-5 Products: ₦29,700
- More than 5 Products: ₦103,950
- Certified True Copy of NAFDAC Documents (per page): ₦5,000
For product variants
- Food/Cosmetics: ₦22,000
Clinical trial fees
- Application Fee: ₦250,000
- Inspection Fee: ₦350,000
- Self-Funded Individual Trials (Local): ₦50,000
- Institutional Grant Aided Trials: ₦300,000
- Extension of Study: ₦50,000
Conclusion: Why NAFDAC Is Key to Your Business’ Success
The NAFDAC registration process might seem difficult, but it’s necessary if you’re serious about building a reputable and safe business in Nigeria. From protecting consumers to avoiding legal troubles, NAFDAC certification is your ticket to a trustworthy brand that consumers can rely on.
So, take a deep breath, gather your documents, and start the process. It might take a little time, but once you’re certified, you’ll be setting your business up for long-term success in Nigeria’s competitive market.