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Regulatory & Compliance Guides

Navigate NAFDAC, SON, and product compliance requirements across Nigeria and Africa. Clear, practical guidance for manufacturers.

Key Regulatory Bodies

Understanding who regulates what is the first step to compliance.

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NAFDAC

National Agency for Food and Drug Administration and Control

Regulates

Food, drugs, cosmetics, medical devices, chemicals, packaged water

Key Requirement

All regulated products must be registered before commercial sale

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SON

Standards Organisation of Nigeria

Regulates

Industrial standards, quality assurance, product certification

Key Requirement

Products must meet NIS (Nigerian Industrial Standards) for labelling, quality, and safety

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NESREA

National Environmental Standards and Regulations Enforcement Agency

Regulates

Environmental compliance, waste management, emissions

Key Requirement

Manufacturing facilities must comply with environmental impact assessment requirements

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Regulations by Country

Detailed compliance information for key African markets.

Who needs to register

Any manufacturer or importer of food, drugs, cosmetics, medical devices, or chemicals intended for sale in Nigeria.

Registration steps

  1. Create an account on the NAFDAC portal
  2. Submit product dossier (formulation, lab analysis, packaging details)
  3. Pay registration fees (varies by product category)
  4. Facility inspection by NAFDAC officers
  5. Product evaluation and testing
  6. Certificate of Registration issued (valid for 5 years)
Estimated Timeline
3 – 6 months
Estimated Cost
₦50,000 – ₦500,000
Important: Manufacturing without NAFDAC registration is a criminal offence under Nigerian law.

What it covers

Product labelling, quality marks (NIS mark), mandatory conformity assessment for locally manufactured and imported products.

Key standards

  • NIS 106 Soaps and detergents
  • NIS 369 Cosmetics and personal care products
  • NIS 268 Paints and coatings
  • NIS 554 Packaged drinking water

Process

  1. Apply to SON for product certification
  2. Product testing at SON laboratory
  3. Factory audit by SON inspectors
  4. Certificate issued upon compliance

SONCAP (imported products)

For imported products, a SONCAP Certificate of Conformity is required before shipping goods to Nigeria.

When it applies

Manufacturers with chemical waste, emissions, or effluent discharge from their production processes.

Key requirements

  • Environmental Impact Assessment (EIA) before establishing a facility
  • Waste management plan for all manufacturing by-products
  • Effluent treatment systems for liquid discharge
Inspection Frequency
Annual or triggered by complaints

FDA Ghana

Food and Drugs Authority

  • Regulates food, drugs, cosmetics, and household chemicals
  • Registration via the FDA Ghana online portal
  • Estimated timeline: 2 – 4 months
  • Product dossier and labelling review required

GSA

Ghana Standards Authority

  • Sets product quality and labelling standards
  • GS mark certification for conforming products
  • Factory inspection and product testing required

KEBS

Kenya Bureau of Standards

  • Regulates manufactured goods quality and standards
  • Diamond Mark of Quality for certified products
  • Import Standardization Mark (ISM) for imports

PPB

Pharmacy and Poisons Board

  • Regulates pharmaceuticals and some cosmetics
  • Product registration required before sale
  • Good Manufacturing Practice (GMP) compliance

SAHPRA

South African Health Products Regulatory Authority

  • Regulates health products, cosmetics, and foodstuffs
  • Licensing and registration of health products
  • Facility inspections for GMP compliance

SABS

South African Bureau of Standards

  • Product quality and conformity marks
  • SABS mark of approval for certified products
  • Testing and certification services

NRCS

National Regulator for Compulsory Specifications

  • Mandatory product safety specifications
  • Letter of Authority required for regulated products
  • Covers electrical goods, chemicals, and consumer products

Your Compliance Checklist

Follow these steps to ensure your products meet regulatory requirements.

Identify your product category and applicable regulatory body

Prepare your product dossier (formulation, ingredients, lab tests)

Register your manufacturing facility

Apply for product registration or certification

Ensure labelling meets local standards (ingredients, batch number, expiry, manufacturer details)

Schedule facility inspection

Maintain records for audit and renewal

Plan for certificate renewal (typically every 3 – 5 years)

Frequently Asked Questions

Quick answers to common regulatory and compliance questions.

Yes. All cosmetics sold in Nigeria must be registered with NAFDAC. This applies to both locally manufactured and imported products. Selling unregistered cosmetics is illegal and may result in product seizure, fines, or prosecution.

Fees vary by product category. Food products, cosmetics, and household chemicals each have different fee schedules. Expect to pay between ₦50,000 and ₦500,000 depending on the category, plus costs for lab testing, facility upgrades, and professional consultants if needed.

No. Commercial sale before registration is complete is prohibited. You must wait until your Certificate of Registration is issued before distributing or selling the product. Selling unregistered products can lead to penalties and criminal charges.

NAFDAC officers will inspect your manufacturing premises to verify compliance with Good Manufacturing Practice (GMP) standards. They will review your production area, storage facilities, equipment, hygiene practices, quality control processes, and record-keeping. Ensure your facility is clean, well-maintained, and properly documented before the visit.

Yes. If exporting to other countries, you need to meet the destination country's regulatory requirements in addition to Nigerian standards. Each country has its own registration process. For example, exporting to Ghana requires FDA Ghana registration, while Kenya requires KEBS certification.

Our team can guide you through regulatory requirements, connect you with accredited laboratories for product testing, and help prepare your product dossier. We also provide formulation support that takes compliance into account from the start, so you can avoid costly reformulations later.

Need help navigating compliance?

Our team can guide you through the registration process, connect you with accredited labs, and help you get to market faster.