Regulatory Licensing

NAFDAC / SON Product Registration Services in Nigeria

Registration support for food, pharmaceutical, cosmetic and manufactured products under NAFDAC and the Standards Organisation of Nigeria.

Services

What the firm provides

  • 1.NAFDAC & SON product pre-registration consultations.
  • 2.Product trademark & NOTAP registration services.
  • 3.Product manufacturing agreement preparation / drafting & vetting.
  • 4.Power of Attorney documentation for foreign manufacturers needing a legal representative to interface with NAFDAC and SON.
  • 5.Ensuring notarization of all documentary filings needed for NAFDAC & SON registration.
  • 6.Securing NAFDAC advertisement approvals.
  • 7.Importer of Record / local agent representation services for international businesses without a physical structure in Nigeria.
FAQs

Frequently Asked Questions

What are the requirements for NAFDAC registration of food, pharmaceutical drugs and cosmetic products?

NAFDAC maintains separate registration requirements for every unique product formulation or size before it can be marketed, manufactured, imported or distributed in Nigeria. Applications are filed via the NAPAMS online portal, and generally require company incorporation documents, proof of trademark registration, a certified Fumigation Certificate, and a valid factory tenancy or site ownership agreement (such as a certificate of occupancy). For imported goods, foreign brands must provide an authenticated Power of Attorney appointing a local representative, a Certificate of Manufacture and Free Sale, and an official letter of invitation for NAFDAC to execute overseas Good Manufacturing Practice (GMP) inspections.

Food products additionally require: Food Handlers' Medical Certificates for all kitchen/factory personnel (validated negative test results for Sputum, Stool, Urinary, Widal/Typhoid and Hepatitis B); comprehensive written Standard Operating Procedures covering production, cleaning, water purification, personal hygiene and product recall protocols; and label specifications showing brand name, full ingredient list, manufacturing/expiry dates, batch number, net weight and space reserved for a future NAFDAC number. Applications in this category typically take 90 working days.

Cosmetics require INCI-formatted ingredient listing (vague groupings are automatically rejected), detailed batch formulation documentation, and laboratory testing for heavy metals confirming the absence of mercury, hydroquinone or unauthorized corticosteroids. Applications typically take 90–120 working days.

Drugs carry the highest level of scrutiny: a signed Certificate of Pharmaceutical Product (COPP) endorsed under WHO guidelines; a comprehensive certificate of analysis from an accredited laboratory; clinical trial and stability study data (including Zone IVB hot/humid climate performance); and an application driven by a superintendent pharmacist registered with the Pharmacy Council of Nigeria (PCN). New chemical entity registrations can take up to 240 working days.

What are the product registration requirements of the Standards Organisation of Nigeria (SON)?

SON has regulatory jurisdiction over the quality and safety of manufactured goods, industrial materials and consumer products not covered by NAFDAC. Registration is split between MANCAP (local manufacturing) and SONCAP (international imports), commenced via the SON e-Product Registration Portal.

MANCAP (local manufacturing) requires: CAC incorporation documents; proof of tax registration; proof of trademark registration; detailed SOPs covering raw material testing, manufacturing and packaging workflows; internal testing/calibration and daily batch quality records; documentation of staff technical qualifications; and a mandatory physical factory audit by SON inspectors, with samples taken for laboratory testing.

SONCAP (imports) is a two-stage process. Stage 1 — Product Certificate (PC): obtained before cargo leaves the country of origin from a SON-approved Independent Accredited Firm (e.g. Cotecna, SGS, Intertek, Bureau Veritas), via one of three routes — Route A (infrequent importers: per-shipment inspection), Route B (regular importers: 1-year Registered status after type-testing), or Route C (high-volume/licensed manufacturers: 1–3 year Licensed status after a full factory audit). Stage 2 — SONCAP Certificate (SC): once the PC is issued, the importer opens a Form M on the Nigeria Trade Single Window portal, then submits the final commercial invoice, packing list and Bill of Lading to the IAF to secure the SC, mandatory for customs clearance.

Post-importation: after clearing customs, the importer must register on the domestic SON e-Product Registration Portal before retail distribution, requiring the CAC certificate, trademark certificate or distribution franchise agreement, Power of Attorney or Manufacturer's Representation Agreement, clear digital photographs of packaging, copies of the PC and SC, and a Remita payment receipt (RRR).

What is the regulatory fee range (minus legal & other fees) for NAFDAC & SON product registration?

NAFDAC — Local MSME manufacturing (Cottage/Micro scale): Food products ₦36,000–₦50,000 per product · Cosmetics ₦50,000 per product · Packaged/sachet water ₦150,000–₦350,000 (includes borehole analysis and facility inspection).

NAFDAC — Large-scale local & imported products: Pharmaceuticals/human drugs ₦70,000 per product · Medical devices ₦30,000 per product · Household chemicals/disinfectants ₦40,000 per product · Imported foreign products $1,000–$1,500 per product (covers import permit, laboratory analysis and certificate processing).

SON — MANCAP (valid 3 years, tiered by company size, 1–5 products): Cottage/Micro ₦7,500 · Small-scale ₦37,500 · Medium-scale ₦97,500 · Large-scale ₦195,000.

SON — SONCAP (dollar-denominated, paid to accredited inspection firms): Product Certificate — Unregistered/Route A $500 (6 months, per-shipment inspection); Registered/Route B $1,000 (1 year); Licensed/Route C $2,000 (1 year, after offshore factory audit). SONCAP Certificate $350 per cargo shipment. System add-ons: $350 for a new product line, $120 for an extra model on an active certificate.

Please note: This page and its contents neither constitute legal advice nor prohibited advertising as prescribed by the Rules of Professional Conduct for Legal Practitioners in Nigeria.

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