NAFDAC permits for unregistered medicines in Nigeria

Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) starts from a simple rule: a medicine is registered before it is imported, sold or distributed. When a hospital needs a medicine that has no NAFDAC registration, the only lawful way in is a NAFDAC permit that covers the specific product, quantity and consignee, issued before the goods leave the exporting country.

This guide explains the permit types that exist, who applies, the order of the steps, the documents and the 2026 trade measures that affect medicines. The Nigeria import guide has the country summary, and how named-patient supply works explains the general model.

How NAFDAC controls medicine imports

NAFDAC regulates the registration, import, distribution and export of medicines. It works with the Nigeria Customs Service at the ports, and clearance of regulated imports runs online through its Ports Inspection system, PIDCARMS. A consignment shipped before the right permit is issued risks detention or re-export.

NAFDAC has warned publicly against parallel imports of unregistered prescription medicines. Two consequences follow for anyone sourcing from India:

• A product that is registered in Nigeria by another company is normally imported by, or with the authority of, the registration holder.
• A product that is not registered needs its own permit, and the permit type should be agreed with NAFDAC before an exporter books freight.

Permit types for products outside full registration

The Drug and Related Products Registration Regulations allow NAFDAC to grant a permit to import a drug outside full registration for defined purposes, including samples for registration, clinical trials, the Service Drug Scheme, emergency use during disease outbreaks and humanitarian donations. The import must follow the conditions written on the permit.

The Service Drug Scheme

Under the Service Drug Scheme, use is limited to the receiving premises named on the permit. That makes it the closest published fit for a teaching hospital or specialist centre that needs a specific unregistered medicine for its patients. Because NAFDAC does not publish a named-patient guideline, the hospital or its licensed importer should confirm in writing that this is the right permit before the exporter issues final documents.

Personal use

Some secondary guides describe a NAFDAC permit for an individual patient's personal use, based on a prescription from a Nigerian practitioner. It was not found in a NAFDAC guideline reviewed for this article, so treat it as unconfirmed and ask NAFDAC first. A patient or family member should ask the treating physician or hospital to request the medicine through a licensed importer.

How a hospital request usually runs

1. The treating physician documents the need. A prescription and a letter explain the diagnosis and why no NAFDAC-registered alternative is suitable.
2. The hospital or licensed importer contacts NAFDAC. It confirms the permit type and the documents NAFDAC will expect for that product.
3. The exporter prepares the dossier. A supplier in India issues a proforma invoice and provides the certificate of analysis, GMP certificate and a certificate of pharmaceutical product or proof of registration in the country of origin.
4. The applicant files for the permit. The application goes in with the proforma and product documents, and the importer opens Form M, the Nigerian import declaration, through an authorised bank.
5. NAFDAC issues the permit. The permit fixes the product, quantity and consignee, and its conditions bind the import.
6. The exporter clears Indian controls and ships. Medicines that are unapproved or new in India need a CDSCO export no objection certificate, explained in Indian export rules buyers should know.
7. NAFDAC inspects and releases at the port. The clearing agent presents the permit and documents through PIDCARMS, and the goods move to the hospital.

Documents and timeline

A typical consignment carries the NAFDAC permit issued to the Nigerian consignee, the prescription and physician letter, the proforma invoice, commercial invoice and packing list, a certificate of analysis for each batch, the GMP certificate, the certificate of pharmaceutical product, Form M and the air waybill. Donations also carry the certificate of donation. The document checklist builds the list for a given product.

Total: roughly 4 to 10 weeks from request to delivery, most of it waiting for the permit. These are planning estimates, not published service times. The lead-time estimator shows how each step adds up.

Controlled medicines and donations

NAFDAC's narcotics guideline requires an import permit and, separately, a permit to clear for narcotic drugs, psychotropic substances and precursors, and it limits applications to the holder of the product's certificate of registration. On the Indian side, the Narcotics Commissioner's export authorisation requires the importing government's original import certificate, covers one consignment and cannot be amended or extended (Central Bureau of Narcotics).

For donations, NAFDAC deals with the Nigerian recipient organisation, not the donor. The recipient applies before the products are imported, with a certificate of donation or evidence of the arrangement. NGOs supplying programmes funded by international donors should also check product eligibility, as covered in WHO prequalification and donor-funded tenders.

2026 trade measures, duties and taxes

• Import restrictions. Nigeria's 2026 Fiscal Policy Measures restrict some medicaments from outside ECOWAS from 1 April 2026. Press reports name paracetamol, metronidazole, cotrimoxazole and chloroquine products among them. Specialty and orphan medicines were not named in the reports reviewed.
• Duty. World Bank WITS data shows 0 percent ECOWAS tariff duty on HS 3004 medicines, although some lines such as antimalarials are reported at 20 percent under the 2026 measures.
• VAT and levies. Medical and pharmaceutical products are zero-rated for VAT under the Nigeria Tax Act 2025 from 1 January 2026. The 0.5 percent ECOWAS levy and a 1 percent CISS fee are reported to apply, and the landed cost calculator includes them.
• Shipping. Most air freight from India to Lagos or Abuja connects through a hub such as Dubai, Doha, Addis Ababa or Nairobi, then waits for NAFDAC inspection. Cold-chain lots need packaging qualified for extra hold time, and CIP or DAP terms suit a consignee that holds the permit.

Practical tips for hospitals and importers

• Agree the permit type with NAFDAC before the exporter books freight, and share the permit with the exporter before dispatch.
• Keep the product name, strength, pack size and quantity identical across the permit, invoice, packing list and air waybill.
• Ask the importer what remaining shelf life NAFDAC port inspection will accept, since no published rule was found.
• Arrange cold-room space with the clearing agent for temperature-sensitive lots, because inspection and release can take several days. The cold-chain transit checker helps size the packaging.
• Ask the exporter for the manufacturer's batch documents and the supply chain from manufacturer to export, which the guide on avoiding falsified medicines explains.