Regulatory Affairs · NAFDAC Registration

How to Register a Drug with NAFDAC: Step by Step Process for 2026

Who can apply, what happens at each of the six stages from NAPAMS to the Certificate of Registration, how long it really takes, and the faster reliance routes for products approved elsewhere.

By MedNova Lifesciences Last updated: October 2026 ~9 min read Step-by-Step Guide

Reviewed for regulatory accuracy by the MedNova Lifesciences regulatory affairs team · This article summarises publicly available NAFDAC registration requirements for educational purposes. Requirements should be confirmed against the current guidelines and tariff before submission.

Quick answerTo register an imported drug with NAFDAC, a Nigerian incorporated company applies on NAFDAC's NAPAMS portal, one application per product. The dossier is screened, documents and labels are reviewed, NAFDAC issues a permit to import registration samples, the samples are analysed, the manufacturing site's GMP status is confirmed, and the Food and Drug Registration Committee approves the product. NAFDAC then issues an electronic Certificate of Registration valid for five years. NAFDAC's guideline sets 240 working days from acceptance of a submission to issue of the registration number, with the clock stopping while queries are open. Products already approved by a stringent regulatory authority or prequalified by WHO can use reliance routes with a 60 working day decision target.
Regulatory noteThis guide follows NAFDAC's Guidelines for Registration of Imported Drug Products in Nigeria (Doc. Ref. DR&R-GDL-005-03, effective 20 March 2025). Locally manufactured products follow separate NAFDAC guidelines.

Before you start: who can apply

NAFDAC registers products through a Nigerian applicant, not directly through a foreign manufacturer. Under the imported drugs guideline:

  • The applicant must provide evidence of incorporation with the Corporate Affairs Commission in Nigeria
  • Where the applicant does not own the brand, it needs a Power of Attorney from the manufacturer
  • Where the applicant owns the brand and a third party manufactures it, it needs a Contract Manufacturing Agreement, notarised in the country of manufacture and signed by both parties
  • A separate application is required for each product

The Power of Attorney has specific requirements. It must be signed by the manufacturer's Managing Director, General Manager, Chairman or President, name the products covered, state the authority to register the products with NAFDAC, state who owns the brand, be notarised in the country of manufacture, and be valid for at least five years.

Getting these documents right before applying avoids the most common early delays. Our registration preparation guide and market entry and compliance overview cover the groundwork, and our article on selling medicines in Nigeria without local regulatory support explains why the local applicant matters.

The NAFDAC registration process, step by step

Every imported drug passes through the same six stages. The overview below links to each one.

  1. 01NAPAMS & screening
  2. 02Document & label review
  3. 03Samples & lab analysis
  4. 04GMP inspection
  5. 05Committee approval
  6. 06Certificate issued
Step 1

Apply on NAPAMS and pass dossier screening

Applications are made on NAFDAC's NAPAMS portal at registration.nafdac.gov.ng. For human medicines, screening clearance of the dossier is a prerequisite before the application moves forward. The applicant uploads the required documents, including the corporate documents, the Power of Attorney or Contract Manufacturing Agreement, and an invitation letter for the GMP inspection of the overseas manufacturing site.

At screening, NAFDAC also places the dossier in a risk tier under its risk categorisation guideline (Doc. Ref. DR&R-GDL-033-01). Low risk dossiers receive screening, medium risk dossiers an abridged review, and high-risk dossiers, such as new molecules or products from new manufacturers outside stringent regulatory authority regions, a full review. The tier largely decides how deep and how long the review will be.

Step 2

Document and label review, and the sample import permit

NAFDAC reviews the documents and the proposed labels. When both are satisfactory, it issues a Permit to Import Registration Samples, which allows the applicant to bring in the samples needed for analysis.

Step 3

Sample submission and laboratory analysis

The applicant submits the samples with a sample submission letter, evidence of payment of the processing fee, a Certificate of Analysis on the testing laboratory's letterhead, and a copy of the sample permit. NAFDAC's laboratories analyse the product against its specifications.

Step 4

GMP inspection of the manufacturing site

NAFDAC must be satisfied with the GMP status of the manufacturing site. For overseas factories, the applicant supplies the invitation letter at Step 1, and the inspection itself is handled by NAFDAC's Drug Evaluation and Research Directorate.

TipSchedule the inspection early. It is often the longest wait in the process.

Step 5

Approval by the Food and Drug Registration Committee

Once the dossier review, GMP status and laboratory analysis are satisfactory, the product goes to the Food and Drug Registration Committee for approval.

Step 6

Issue of the Certificate of Registration

Approved products receive an electronic Certificate of Product Registration. The certificate is valid for five years, and NAFDAC may revoke, suspend or vary it during that time.

How long does NAFDAC registration take?

NAFDAC's imported drugs guideline states that registration takes 240 working days from acceptance of a submission to issue of the registration number.

240working days
Standard route, from acceptance of a submission to issue of the registration number
90working days
Maximum time to answer a query before the application closes automatically
60working days
Decision target under the reliance and WHO collaborative routes

Three rules shape the real timeline:

  • The clock stops whenever NAFDAC issues a compliance request, and restarts when the applicant responds
  • Queries must be answered within 90 working days, or the application closes automatically
  • The risk tier from screening affects how much review the dossier receives

In practice, the total time depends most on how complete the dossier is at submission, how quickly GMP inspection can be scheduled, how long sample analysis takes, and how fast the applicant answers queries. A complete, consistent dossier is the single biggest factor within the applicant's control.

Faster routes: reliance and collaborative registration

NAFDAC operates reliance pathways for products already assessed by trusted authorities. Its reliance procedure guideline (Doc. Ref. DR&R-GDL-035-00) covers drugs, vaccines and in vitro diagnostics confirmed by a stringent regulatory authority or by partners such as WAHO and the AMRH programme, and sets a registration decision within 60 working days, approximately 90 calendar days. The product must be the same as the one the reference authority approved: same manufacturing chain, specifications, product information and indications. Applicants submit complete, unredacted assessment reports, and NAFDAC keeps the final decision.

WHO prequalified products have a parallel route through NAFDAC's Collaborative Registration Procedure guideline, also with a 60 working day decision target. Our comparison of WHO prequalification and NAFDAC registration explains when that route applies, and our article on the African Medicines Agency covers continental reliance.

Labelling requirements

NAFDAC's guideline sets out what labels must carry. Key requirements include:

  • The brand name where applicable, with the generic name conspicuous and directly under it
  • The manufacturer's name and full address
  • Provision for the NAFDAC registration number
  • Batch number, manufacturing date and expiry date
  • Dosage form, strength, and active ingredients listed quantitatively per unit dose
  • Net content, storage conditions and adequate warnings
  • A Patient Information Leaflet, and prescribing information for prescription only products
  • An English translation on the label and leaflet where the original is in another language

Labels that resemble already registered products are not eligible.

Special cases

New chemical entities

Require clinical trial reports from the relevant population.

Generics

Bioequivalence reports or biowaiver data are submitted in CTD format.

Combination products

Need documented evidence of clinical advantage over the single drugs.

Advertising

Registration does not include permission to advertise. Advertising needs a separate NAFDAC application.

Filing is not registrationSubmitting an application or paying a fee does not give a product registered status.

Why applications stall

  • A Power of Attorney missing a required element, such as product names or the five year validity
  • Documents not notarised in the country of manufacture
  • Labels that don't meet the labelling requirements or resemble an existing product
  • Late scheduling of the GMP inspection
  • Samples imported without the permit, or submitted without a matching Certificate of Analysis
  • Queries left unanswered until the 90 working day limit closes the file
  • Missing bioequivalence data for generics

After registration

Registration starts a new set of obligations. The certificate must be renewed before it expires (NAFDAC publishes separate renewal guidelines), and changes to the product, manufacturing site or labels need variations.

The Certificate of Registration Holder also takes on pharmacovigilance duties, including a Qualified Person for Pharmacovigilance resident in Nigeria and a Pharmacovigilance System Master File, which is submitted with the registration application. Our complete guide to pharmacovigilance in Nigeria covers those duties, our guide to the QPPV in Nigeria explains the role, and our comparison of in-house and outsourced QPPV models helps companies decide how to resource it.

Registration readiness checklist

Work through this list before opening an application on NAPAMS.

NAFDAC registration readiness

  • Nigerian applicant incorporated with the Corporate Affairs Commission
  • Power of Attorney or Contract Manufacturing Agreement meeting every NAFDAC requirement
  • NAPAMS account set up, one application per product
  • Dossier complete, consistent and in CTD format
  • GMP inspection invitation letter for the manufacturing site
  • Labels and Patient Information Leaflet checked against NAFDAC's labelling rules
  • Plan for importing and submitting registration samples
  • Bioequivalence or clinical data where required
  • Reliance eligibility checked if the product holds stringent authority approval or WHO prequalification
  • Pharmacovigilance arrangements, QPPV and master file ready for submission

Want a second pair of eyes on your dossier? Talk to our regulatory team before you submit.

Frequently asked questions

How do I register a drug with NAFDAC?

Through a Nigerian incorporated applicant on NAFDAC's NAPAMS portal. The steps are dossier screening, document and label review, a permit to import samples, laboratory analysis, GMP confirmation, approval by the Food and Drug Registration Committee, and issue of the Certificate of Registration.

How long does NAFDAC registration take?

NAFDAC's guideline states 240 working days from acceptance of a submission to issue of the registration number. The clock stops while queries are open. Reliance routes set a 60 working day decision target.

Can a foreign manufacturer register directly with NAFDAC?

No. Registration goes through a company incorporated in Nigeria, authorised by a Power of Attorney or, where the applicant owns the brand, a Contract Manufacturing Agreement.

What portal does NAFDAC use for drug registration?

NAFDAC processes drug registration applications on its NAPAMS portal at registration.nafdac.gov.ng.

How long is a NAFDAC registration valid?

Five years, after which it must be renewed. NAFDAC may revoke, suspend or vary a certificate during its validity.

What happens if I don't answer a NAFDAC query?

Queries must be answered within 90 working days. If they are not, the application closes automatically.

Is there a faster route for products approved elsewhere?

Yes. NAFDAC's reliance procedure and its Collaborative Registration Procedure for WHO prequalified products both set a decision target of 60 working days, provided the product is the same as the one the reference authority approved.

Does NAFDAC registration allow me to advertise the product?

No. Advertising requires a separate application to NAFDAC.

Do I need a QPPV to register a drug in Nigeria?

The Pharmacovigilance System Master File, which records the QPPV, is submitted with the registration application, and the Certificate of Registration Holder must have a QPPV resident in Nigeria.

How MedNova supports NAFDAC registration

MedNova Lifesciences provides regulatory affairs support in Nigeria covering the full registration process: applicant and document readiness, NAPAMS submissions, CTD dossier preparation, label review, sample import, GMP inspection coordination, query responses, reliance submissions, renewals and variations. Because we also provide pharmacovigilance services, including local QPPV representation, a product's registration and safety obligations can be handled by one partner. We also support clinical development. See our capability statement.

Related reading: our NAFDAC product registration guide, the regulatory affairs primer, ICH guidelines compared with NAFDAC requirements, and the resources library.

Next step: contact our team to plan your NAFDAC registration.

Planning a NAFDAC registration?

MedNova Lifesciences prepares dossiers, manages NAPAMS submissions, coordinates GMP inspections and answers NAFDAC queries, with pharmacovigilance and QPPV cover from the same team.

Contact MedNova Lifesciences

Related resources

NAFDAC Registration Documents Checklist for Imported Drugs NAFDAC Product Registration in Nigeria NAFDAC Registration Preparation Guide WHO Prequalification vs NAFDAC Registration Can You Sell Medicines in Nigeria Without Local Regulatory Support? The African Medicines Agency and NAFDAC NAFDAC Registration Services

References

  1. National Agency for Food and Drug Administration and Control. Guidelines for Registration of Imported Drug Products in Nigeria, Human and Veterinary Drugs (DR&R-GDL-005-03). nafdac.gov.ng
  2. National Agency for Food and Drug Administration and Control. Guidelines for Registration and Related Activities of Drugs, Vaccines and In Vitro Diagnostics Using the Reliance Procedure (DR&R-GDL-035-00). nafdac.gov.ng
  3. National Agency for Food and Drug Administration and Control. Revised Guidelines for Risk Categorization of Product Dossiers for the Registration of Drug Products for Human Use (DR&R-GDL-033-01). nafdac.gov.ng
  4. National Agency for Food and Drug Administration and Control. Guidelines for Registration of Drugs, Vaccines and IVDs under the WHO Collaborative Registration Procedure (R&R-GDL-O17-OO). nafdac.gov.ng
  5. National Agency for Food and Drug Administration and Control. Guidelines for Renewal of Certificate of Registration for Imported Drug Products. nafdac.gov.ng
  6. National Agency for Food and Drug Administration and Control. NAPAMS registration portal. registration.nafdac.gov.ng
  7. National Agency for Food and Drug Administration and Control. Regulatory resources and guidelines index. Use this page to confirm the current edition of any guideline referenced above.
  8. MedNova Lifesciences. Pharmacovigilance services, Nigeria and Africa. mednovalife.com/pv.html
  9. MedNova Lifesciences. Regulatory affairs services, Nigeria and Africa. mednovalife.com/regulatory.html