NAFDAC Import Permit Application (Nigeria)

A NAFDAC Import Permit Application in Nigeria submits the applicant's details to the relevant authority for the approval it seeks.

Under Section 5(1) of the NAFDAC Act (Cap N1, LFN 2004), NAFDAC has exclusive authority to grant or refuse import permits for regulated products entering Nigeria. No person or company may import any regulated product without a valid NAFDAC import permit, and importation without a permit constitutes a criminal offence under Section 25 of the NAFDAC Act, attracting fines and imprisonment of not less than one year. The Nigeria Customs Service, acting under the Customs and Excise Management Act (Cap C45, LFN 2004), detains shipments lacking valid NAFDAC import permits at ports of entry including Apapa Port, Tin Can Island Port, and Murtala Muhammed International Airport (MMIA).

NAFDAC administers two categories of import permits: the Import Permit for Registered Products (for products that have received NAFDAC product registration certification bearing a NAFDAC registration number) and the Import Permit for Unregistered Products (a temporary permit for clinical samples, research materials, compassionate use drugs, or products awaiting registration under NAFDAC's Drug Evaluation and Research Directorate (DERD)). The standard import permit for registered products is valid for 12 months from the date of issue and covers a specified quantity and value of the product.

For pharmaceuticals (prescription drugs, over-the-counter medicines, and vitamins/supplements), NAFDAC applies the WHO Model Certificate of Pharmaceutical Products (CPP) requirement — imported drugs must be accompanied by a CPP issued by the regulatory authority of the country of manufacture. NAFDAC's Drug Evaluation and Research Directorate (DERD) handles pharmaceutical import permits, while the Food Safety and Applied Nutrition Directorate (FSAND) handles food import permits.

NAFDAC import permit applications are submitted through the NAFDAC online portal (nafdac.gov.ng) using the NAFDAC e-Submission system, introduced in 2021 as part of NAFDAC's digital transformation under Director-General Prof. Mojisola Adeyeye. Physical submissions are no longer accepted at NAFDAC headquarters in Abuja for most categories. Payments are processed through the Remita gateway of the Office of the Accountant-General of the Federation.

Importers must also register with the Corporate Affairs Commission (CAC) under the Companies and Allied Matters Act 2020 (CAMA 2020) and obtain a Tax Identification Number (TIN) from the Federal Inland Revenue Service (FIRS) as prerequisites for NAFDAC importer registration. The National Office for Technology Acquisition and Promotion (NOTAP) review may be required where the importation involves a technology transfer component. The Nigeria Data Protection Act 2023 (NDPA 2023), administered by the Nigeria Data Protection Commission (NDPC), applies to the processing of personal data during the application process. Disputes arising from NAFDAC permit decisions may be appealed to the Federal High Court of Nigeria, which has jurisdiction over federal regulatory bodies under Section 251 of the Constitution of the Federal Republic of Nigeria 1999 (as amended).

A NAFDAC Import Permit Application in Nigeria is required every time a company or individual imports a regulated product into Nigeria.

A NAFDAC Import Permit Application is needed when a pharmaceutical importer or distributor wishes to import drugs — including prescription medicines, over-the-counter products, antibiotics, antivirals, or vitamins — from manufacturers in India, China, Europe, or the USA. Nigeria is one of the largest pharmaceutical importers in Africa, and Apapa Port in Lagos handles the majority of pharmaceutical imports.

A NAFDAC Import Permit Application is required when a food importer seeks to bring processed food products, beverages, dietary supplements, or food additives into Nigeria. All packaged food items imported into Nigeria must bear valid NAFDAC registration numbers on their labels before they can be cleared at Nigerian ports of entry by the Nigeria Customs Service.

A NAFDAC Import Permit Application is needed when a medical device company seeks to import hospital equipment, diagnostic devices, surgical instruments, or in-vitro diagnostic (IVD) kits into Nigeria for sale to hospitals, clinics, and laboratories.

A NAFDAC Import Permit Application is required when a cosmetics company imports personal care products, skin care, hair products, or toiletries for distribution in Nigeria. Cosmetics imported without NAFDAC registration and import permit are subject to seizure and destruction at the port of entry.

A NAFDAC Import Permit Application is needed for importation of chemicals, including industrial chemicals, laboratory reagents, and agricultural chemicals, which fall under NAFDAC's regulatory scope for chemicals and allied products.

Parties in Nigeria should prepare a NAFDAC Import Permit Application (Nigeria) proactively rather than waiting for a dispute to arise. Courts interpret agreements based on the written terms rather than oral representations. Under Nigerian law, the Companies and Allied Matters Act 2020 (CAMA) regulates corporate entities through the Corporate Affairs Commission (CAC). The Labour Act (Cap L1 LFN 2004) and the National Industrial Court of Nigeria (NICN) govern employment disputes. The Nigeria Data Protection Regulation (NDPR) 2019 and the Nigeria Data Protection Commission (NDPC) protect personal data. The Federal Inland Revenue Service (FIRS) administers tax obligations under the Companies Income Tax Act. The Federal High Court and state High Courts have jurisdiction over civil matters. Where the transaction involves regulated activities, prior approval from the relevant authority may be required before execution.

A valid NAFDAC Import Permit Application in Nigeria must contain the following essential elements to satisfy Section 5 of the NAFDAC Act (Cap N1, LFN 2004) and NAFDAC Import Permit Guidelines (revised 2023).

Applicant Details: Full legal name of the Nigerian importer, Corporate Affairs Commission (CAC) registration number under the Companies and Allied Matters Act 2020 (CAMA 2020), existing NAFDAC importer registration number, Tax Identification Number (TIN) issued by the Federal Inland Revenue Service (FIRS) under the Companies Income Tax Act (Cap C21, LFN 2004) (CITA), and contact details of the responsible officer and the NAFDAC-registered Superintendent Pharmacist (for pharmaceutical importers under the Pharmacists Council of Nigeria (PCN) Act).

Product Information: Full product name and NAFDAC classification category (drug under the Pharmacy Act Cap P17 LFN 2004, food, cosmetic, medical device, chemical, or veterinary product), brand name, International Non-proprietary Name (INN) for drugs, active ingredients with concentrations, dosage form (tablets, capsules, syrup, injection), pack sizes, and the NAFDAC product registration number from the NAFDAC Trademarks, Patents and Registration Directorate. For food products, the Standards Organisation of Nigeria (SON) standard reference under the SON Act (Cap S9, LFN 2004) must be included.

Manufacturer Details: Full name and address of the foreign manufacturer, country of manufacture, WHO Certificate of Pharmaceutical Products (CPP) reference (mandatory for drugs under NAFDAC's Drug Evaluation and Research Directorate (DERD)), Good Manufacturing Practice (GMP) certificate reference from the manufacturer's national regulatory authority, and the NAFDAC-approved facility reference. For medical devices, compliance with ISO 13485 certification and the NAFDAC Medical Devices and Diagnostics Directorate (MDDD) registration must be confirmed.

Importation Details: Proposed quantity in units, kilograms, or litres; total value in USD and NGN equivalent at the Central Bank of Nigeria (CBN) official exchange rate; country of origin; designated port of entry (Apapa Port, Tin Can Island Port, Murtala Muhammed International Airport (MMIA) cargo terminal, Onne Port Rivers State, or Calabar Port Cross River State); Nigeria Customs Service (NCS) Bill of Lading reference; and proposed importation period within the 12-month permit validity.

Supporting Documents: Certificate of Analysis (COA) from the manufacturer's quality control laboratory, WHO CPP for pharmaceuticals, manufacturer's product Summary of Product Characteristics (SmPC) or product dossier, current NAFDAC product registration certificate, proof of NAFDAC import permit fee payment through the Remita gateway of the Office of the Accountant-General of the Federation (fees range from NGN 50,000 to NGN 500,000 by product category as of 2024), the importer's FIRS TIN confirmation letter, and — for pharmaceuticals — a Pharmacist's Declaration signed by a Superintendent Pharmacist registered with the Pharmacists Council of Nigeria (PCN).

Declaration, NDPA Compliance, and Governing Law: A signed declaration by the importer that all information is accurate, the products comply with NAFDAC standards under Section 5 of the NAFDAC Act (Cap N1, LFN 2004), and the importer undertakes to comply with all permit conditions. The Nigeria Data Protection Act 2023 (NDPA 2023) administered by the Nigeria Data Protection Commission (NDPC) governs personal data processed during the application. The NAFDAC e-Submission reference number from nafdac.gov.ng tracks the application status. Appeals against NAFDAC permit refusals lie to the Federal High Court of Nigeria under Section 251 of the Constitution of the Federal Republic of Nigeria 1999 (as amended). NAFDAC decisions are also subject to review under the Administrative Procedure Act principles as applied by Nigerian courts. Forms-legal.com provides this template as a starting point — applicants should verify current NAFDAC guidelines, FIRS fee schedules, and NCS import duty requirements before submission.