Requirement to Register a Product with NAFDAC

Getting a product into the Nigerian market legally is impossible without NAFDAC registration. The requirement to register a product with NAFDAC is not just a formality. It is a strict legal process that ensures safety, quality, and compliance. Any product that falls under food, drugs, cosmetics, medical devices, chemicals, or packaged water must meet the NAFDAC requirements for product registration before it can be sold. Failing to comply means facing penalties, seizures, or outright business closure.

NAFDAC doesn’t take shortcuts. The requirement for registering a product with NAFDAC covers everything from production standards to packaging. Businesses must follow the NAFDAC requirements for registration to protect consumers and gain market access. Whether you’re a local manufacturer or an importer, the requirement for NAFDAC registration applies. Understanding the process is the first step to success.

See also: Steps to Follow in Getting a NAFDAC Registration for Your Business

Products Requiring NAFDAC Registration

Not all products need NAFDAC registration, but most consumer goods do. The agency regulates:

• Food products (processed and packaged)
• Pharmaceuticals (prescription and over-the-counter drugs)
• Herbal and natural supplements
• Medical devices
• Cosmetics and beauty products
• Packaged water and beverages
• Chemicals (industrial and consumer use)

If your product falls into any of these categories, you must meet the NAFDAC requirement for registration before selling or distributing it.

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General Requirement to Register a Product with NAFDAC

The NAFDAC requirement for product registration are strict and comprehensive. Businesses must meet all conditions before their products can be approved for sale in Nigeria. Below are the key requirements:

1. Company Registration with CAC

Before applying for NAFDAC registration, a business must be registered with the Corporate Affairs Commission (CAC). Below are the steps involved:

• Choose a Business Name – Check for availability on the CAC portal and reserve the name.
• Complete the CAC 1.1 Pre-Registration Form – Provide company details, business objectives, and shareholder information.
• Prepare Required Documents – This includes the Memorandum and Articles of Association (MEMART), Statement of Share Capital, Particulars of Directors, and valid means of identification for directors/shareholders.
• Pay Registration Fees – Make the required payment based on the business structure.
• Submit Application Online – Upload all documents and complete the registration process via the CAC portal.
• Receive Certificate of Incorporation – Once approved, CAC issues the Certificate of Incorporation, a mandatory requirement for NAFDAC registration.

See also: Business Registration with CAC

2. Good Manufacturing Practice (GMP) Compliance

For locally manufactured products, the production facility must meet Good Manufacturing Practice (GMP) standards before NAFDAC registration can be approved. This ensures that products are consistently produced and controlled according to quality standards.

Steps to Meet GMP Compliance:

• Ensure Proper Facility Setup – The production site must have adequate space, ventilation, and hygiene measures.
• Implement Quality Control Measures – Establish standard operating procedures (SOPs) for production, testing, and record-keeping.
• Provide Proper Equipment and Storage – Machines and storage areas must be suitable for safe production and preservation.
• Train Personnel – Staff involved in production must be well-trained in hygiene, safety, and quality control.
• Prepare for NAFDAC Inspection – NAFDAC officials will conduct a site inspection to verify compliance.

Failure to meet GMP standards can lead to delays or rejection of the NAFDAC registration application.

3. Certificate of Free Sale (For Imported Products)

For imported products, NAFDAC requires a Certificate of Free Sale from the regulatory authority in the country of origin. This document confirms that the product is legally sold and approved in its home country.

Steps to Obtain a Certificate of Free Sale:

• Request from Regulatory Authority – The manufacturer or exporter must obtain this document from the relevant health or food safety agency in the country of origin.
• Authenticate the Document – It should be notarized or certified by the issuing authority.
• Submit to NAFDAC – The Certificate of Free Sale must be included in the product registration application for imported goods.

Without this certificate, NAFDAC will not process the registration of imported products.

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4. Laboratory Testing and Quality Assurance

NAFDAC mandates laboratory testing to confirm product safety and quality before issuing a registration number.

Steps for Laboratory Testing:

• Submit Product Samples – The applicant must provide samples to a NAFDAC-approved laboratory for testing.
• Conduct Required Tests – These may include microbiological, chemical, heavy metal, and stability tests based on the product type.
• Obtain Certificate of Analysis – The laboratory issues a test report detailing the product’s compliance with safety standards.
• Submit Test Results to NAFDAC – The Certificate of Analysis is a key document for product registration.

If a product fails laboratory testing, NAFDAC will reject the application until necessary corrections are made.

5. Product Labeling and Packaging Compliance

NAFDAC has strict guidelines on product labeling and packaging to ensure consumer safety and proper identification.

Steps for Labeling Compliance:

1. Ensure All Required Information is on the Label – This includes:
   • Product name and brand
   • Ingredients list
   • Net weight or volume
   • Manufacturer’s name and address
   • Batch number, manufacturing date, and expiry date
   • NAFDAC registration number (after approval)
   • Usage instructions and precautions
2. Translate to English (If Necessary) – Imported products must have an English translation on the label.
3. Meet Packaging Standards – Packaging must be durable, tamper-proof, and suitable for the product type.

Failure to comply with NAFDAC labeling requirements can result in application rejection or product seizure.

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6. Payment of Prescribed Fees

NAFDAC does not process any application without full payment of registration fees. The requirement to register a product with NAFDAC includes paying the prescribed fees based on product type.

Steps to Pay NAFDAC Registration Fees:

• Obtain the Fee Schedule – Check NAFDAC’s official website or office for the applicable fees.
• Make Payment – Pay through the designated bank or online portal as instructed by NAFDAC.
• Collect Payment Receipt – NAFDAC issues a receipt as proof of payment.
• Attach Receipt to Application – Without proof of payment, the application will not be processed.

Failing to complete this requirement for NAFDAC registration can lead to delays or outright rejection.

7. Power of Attorney (For Foreign Manufacturers)

For imported products, the NAFDAC requirements for product registration demand a Power of Attorney authorizing a Nigerian representative to act on behalf of the foreign manufacturer.

Steps to Obtain a Power of Attorney:

• Draft a Legal Document – The manufacturer must issue a formal Power of Attorney assigning a Nigerian agent.
• Notarize the Document – The document must be notarized in the country of origin.
• Submit to NAFDAC – The authorized representative must include this in the registration application.

Without this document, foreign manufacturers cannot meet the requirements for registering a product with NAFDAC.

See also: Legal Requirements For Entrepreneurs When Starting A Business

8. Product Dossier Submission

A comprehensive product dossier is a critical NAFDAC requirement for registration. It provides detailed information about the product’s composition, safety, and production process.

Steps to Prepare a Product Dossier:

• Compile Product Information – Include the product formula, ingredient list, and method of manufacture.
• Include Stability and Safety Reports – Provide test results proving the product’s quality and shelf life.
• Ensure Compliance with NAFDAC Standards – Format the dossier according to NAFDAC guidelines.
• Submit with Registration Application – A complete dossier speeds up the approval process.

Without a complete dossier, NAFDAC will not approve the application, making it impossible to fulfill the NAFDAC requirements for registration.

9. Import Permit (For Regulated Imported Products)

Importers of regulated products such as pharmaceuticals, food, and chemicals must obtain an Import Permit before bringing goods into Nigeria. This is a mandatory requirement for NAFDAC registration for imported products.

Steps to Obtain an Import Permit:

• Apply to NAFDAC – Submit an application detailing the product type and country of origin.
• Provide Supporting Documents – Attach the Certificate of Free Sale, Power of Attorney, and Product Dossier.
• Make the Required Payment – Pay the official import permit fees.
• Receive Approval – Once granted, the import permit allows the product to enter Nigeria legally.

Without an import permit, customs authorities will seize the product, making it impossible to complete the NAFDAC requirements for product registration.

See also: Mini Importation – How To Start Mini Importation Business In Nigeria

10. Appointment of Technical Officer (For Pharmaceutical Companies)

Pharmaceutical companies must appoint a Technical Officer to oversee regulatory compliance, a strict requirement to register a product with NAFDAC.

Steps to Appoint a Technical Officer:

• Hire a Qualified Professional – The officer must have a degree in Pharmacy, Biochemistry, Microbiology, or a related field.
• Submit Credentials to NAFDAC – Provide copies of the officer’s academic and professional certifications.
• Ensure Ongoing Compliance – The Technical Officer must monitor production standards and regulatory updates.

Without a qualified Technical Officer, NAFDAC requirements for registration will not be met, and the application will be denied.

11. Submission of Completed Application Form

The NAFDAC requirement for product registration includes submitting a fully completed application form, providing detailed product and company information.

Steps to Complete the Application Form:

• Download the Application Form – Obtain the form from the NAFDAC website or office.
• Fill in Product and Company Details – Include information such as product name, manufacturer details, and intended use.
• Attach Required Documents – Ensure the application includes all required supporting documents such as certificates, test results, and fees.
• Submit the Application – Submit the form and all documents to NAFDAC via their online portal or office.

Incomplete applications or missing documents will delay the registration process and result in non-compliance with NAFDAC requirement for registration.

12. NAFDAC Inspection of Manufacturing Facility

For locally produced goods, NAFDAC requires an inspection of the manufacturing facility to ensure compliance with Good Manufacturing Practice (GMP) standards before registration is approved.

Steps for Facility Inspection:

• Request an Inspection – After submitting the application, request a facility inspection by NAFDAC.
• Prepare for Inspection – Ensure that the facility complies with cleanliness, safety, and quality standards.
• Schedule a Visit – NAFDAC will conduct an on-site inspection to assess compliance.
• Provide Necessary Documentation – Have records ready, including equipment maintenance logs, production samples, and employee training certifications.

Failure to pass the inspection means NAFDAC will not approve the registration until corrections are made.

See also: How to Get a Business License in Nigeria For Entrepreneurs

13. NAFDAC Review and Approval

Once you submit all documents and inspections are complete, NAFDAC reviews the application. This is the final step before receiving approval.

Steps for NAFDAC Review:

• Wait for Evaluation – NAFDAC evaluates the application, product samples, test reports, and facility inspection results.
• Respond to Queries (If Any) – NAFDAC may request additional information or clarification.
• Receive Approval or Rejection – If everything meets regulatory standards, NAFDAC issues the registration number. If there are issues, the application is rejected until corrections are made.

Once approved, the business can legally sell the product in Nigeria. Without meeting these NAFDAC requirements for product registration, approval is not granted.

Post-Registration Compliance and Monitoring

Once a product is registered, businesses must continue to meet NAFDAC requirements for registration through ongoing compliance and monitoring.

Steps for Post-Registration Compliance:

• Renew Registration – Product registration is valid for a set period, after which you must renew it.
• Monitor Product Quality – Ensure products continue to meet safety and quality standards.
• Report Adverse Effects – If a product causes health issues, a report must be made to NAFDAC.
• Follow-up Inspections – NAFDAC may conduct random inspections to verify continued compliance.

Failure to comply with these post-registration requirements can result in penalties, product recall, or cancellation of the registration.

Key Takeaways from Requirement to Register a Product with NAFDAC

• NAFDAC Registration is Mandatory: The requirement to register a product with NAFDAC is a legal obligation for all food, drug, cosmetic, medical, and chemical products in Nigeria. Without registration, businesses cannot legally sell these products.
• GMP Compliance is Critical: Locally manufactured products must comply with Good Manufacturing Practice (GMP) to meet NAFDAC requirements for product registration.
• Documents are Essential: To fulfill the NAFDAC requirements for registration, businesses must submit a variety of documents, including laboratory test reports, a certificate of free sale (for imported products), and a comprehensive product dossier.
• Labeling and Packaging Standards: All products must meet NAFDAC requirements for product registration in terms of labeling and packaging, ensuring clear, accurate, and legally compliant product information.
• Import Permits and Power of Attorney: For imported goods, an Import Permit and a Power of Attorney from the manufacturer are necessary to comply with NAFDAC requirements for registration.
• Continuous Compliance: After registration, businesses must maintain compliance through renewal, quality monitoring, and reporting adverse effects, in line with NAFDAC’s ongoing requirements.

Conclusion

Registering a product with NAFDAC is a vital process for ensuring that only safe, high-quality products reach consumers in Nigeria. The requirement to register a product with NAFDAC is non-negotiable for any product whether it is for sale or distribution. By following all the necessary steps and meeting the NAFDAC requirements for product registration, businesses can avoid legal challenges, ensure public health safety, and enjoy smoother market access. Understanding and meeting these regulatory requirements is essential for business success in the Nigerian market.

FAQs on Requirement to Register a Product with NAFDAC

Why is NAFDAC registration important for my product?

NAFDAC registration ensures that your product meets Nigerian safety and quality standards. Without registration, your product is illegal to sell or distribute in Nigeria. It also builds trust with consumers, ensuring them that your product is safe.

What products require NAFDAC registration?

The NAFDAC requirements for registration apply to all food products, pharmaceuticals, medical devices, cosmetics, packaged water, chemicals, and herbal products.

Can I sell my product without a NAFDAC number?

No, selling an unregistered product is illegal in Nigeria. The requirement for NAFDAC registration is mandatory for all products in regulated categories.

How long does it take to register a product with NAFDAC?

The process typically takes several months, depending on the type of product, the completeness of your application, and NAFDAC’s inspection and evaluation timelines.

What happens if my product fails NAFDAC inspection or testing?

If your product fails the inspection or lab tests, NAFDAC will request corrective actions. You will need to address the issues and resubmit your application.

How much does it cost to register a product with NAFDAC?

The cost varies based on the type of product and its category. Check NAFDAC’s fee schedule for specific pricing details related to your product type.