NAFDAC's online registration portal is NAPAMS, the NAFDAC Automated Product Administration and Monitoring System, at registration.nafdac.gov.ng. Applicants submit new product registration applications and renewals on it, with a separate application for each product. Through the portal an applicant uploads the required documents, pays fees, tracks the status of the application, responds to queries and obtains the electronic Certificate of Registration. The portal does not replace the regulatory steps: dossier screening, sample analysis, GMP confirmation and committee approval still apply.
What Is NAPAMS?
NAPAMS is the system NAFDAC uses to receive and process product registration applications. Its address is registration.nafdac.gov.ng. NAFDAC's imported drugs guideline states that applications are made on the NAPAMS portal, and its renewal guideline states that renewal applications are submitted and processed there too.
At a 2023 stakeholder meeting reported by Voice of Nigeria, NAFDAC officials explained that online registration, once limited to certain products, now covers all products NAFDAC regulates. They described a process in which an applicant registers the product online, pays, follows the status and stages of the application, and prints the certificate without visiting a NAFDAC office.
For companies outside Nigeria, this matters in two ways. First, the paperwork moves online, so the quality of scanned and uploaded documents now carries the weight that physical files once did. Second, the account belongs to the Nigerian applicant, not the foreign manufacturer, because NAFDAC registers products through a company incorporated in Nigeria.
What You Can Do on the Portal
- Submit applications for new product registration, one application per product
- Submit renewal applications for registered products
- Upload the supporting documents for each stage
- Pay the fees set out in NAFDAC's Tariff
- Follow the status and stage of each application
- Receive and respond to queries
- Obtain the electronic Certificate of Registration once a product is approved
Bioequivalence reports and biowaiver applications for generics are a separate case. NAFDAC's imported drugs guideline states they are submitted on DMS in CTD dossier format. The full registration sequence, from screening to approval, is set out in our guide on how to register a drug with NAFDAC.
Before You Log In: What to Prepare
Most problems on NAPAMS begin before the first click. The portal accepts what is uploaded, and gaps surface later as queries. Before starting an application, the Nigerian applicant should have:
- Incorporation with the Corporate Affairs Commission
- A current annual licence for its Superintendent Pharmacist from the Pharmacists Council of Nigeria, and a valid premises retention licence
- A Power of Attorney or Contract Manufacturing Agreement that meets every NAFDAC requirement
- Dossier screening clearance, which is a prerequisite for human medicines
- The manufacturer certificates: manufacturing licence or Certificate of Free Sale, and an authenticated COPP and cGMP certificate
- Trademark registration for the brand name
- The GMP inspection invitation letter from the manufacturer
- Final label artwork and the Patient Information Leaflet
Our NAFDAC registration documents checklist lists every document, what NAFDAC checks in each, and the validity rules. Our registration preparation guide covers setting up the applicant company.
Using NAPAMS Step by Step
The sequence below reflects the process described in NAFDAC's guidelines and public statements. Screen labels may differ from the wording used here.
Step 1: Create the Applicant Account
The Nigerian applicant registers on the portal and sets up its company account. Account details should match the company's CAC records exactly, since NAFDAC cross checks the applicant across documents.
Step 2: Start a Product Application
After logging in, the applicant starts a new application. NAFDAC requires a separate application form for each product, so a company registering several strengths or products files several applications.
Step 3: Upload the Step I Documents
The first set of uploads covers the documents in Section 3 of the imported drugs guideline: dossier screening clearance, the application letter to the Director General, the notarised declaration, the Power of Attorney or Contract Manufacturing Agreement, CAC evidence, the manufacturing licence or Certificate of Free Sale, the COPP, the cGMP certificate, trademark evidence, the Superintendent Pharmacist's licence, the premises retention licence and the GMP inspection invitation letter. NAFDAC may ask to see the originals.
Step 4: Pay the Fees
Fees are set out in NAFDAC's Tariff and are paid through the portal process. NAFDAC's guideline is clear that paying an application fee does not confer registration on a product.
Step 5: Track the Application
The applicant follows each application through its stages: document and label review, the permit to import registration samples, sample analysis, GMP confirmation and committee approval. Sample submission happens offline, with a submission letter, proof of the processing fee, a Certificate of Analysis and a copy of the sample permit.
Step 6: Respond to Queries
When NAFDAC needs more information, it issues a query and the review clock stops. For new registrations, queries must be answered within 90 working days or the application closes automatically. Under the renewal guideline the limit is 45 working days. Checking the account regularly matters, because a missed query can end an application.
Step 7: Obtain the Certificate
Once the Food and Drug Registration Committee approves the product, NAFDAC issues an electronic Certificate of Registration, valid for five years.
Renewing a Registration on NAPAMS
NAFDAC's renewal guideline (Doc. Ref. DR&R-GDL-025-01) directs renewal applications to NAPAMS and refers applicants to the NAPAMS User Manual. Key rules:
- Renewal should be started no later than 30 calendar days before the certificate expires
- Each product needs its own renewal application
- Required documents include a Product Quality Review or dossier, the expired Certificate of Registration, an authenticated manufacturing licence and COPP, trademark evidence, a notarised declaration and a list of approved variations
- A new Power of Attorney or Contract Manufacturing Agreement is generally required, valid for at least five years, with limited exceptions set out in the guideline
- Renewal samples go in with a copy of the Notice of Renewal
- NAFDAC's stated timeline is 60 working days from acceptance, with the clock stopped while queries are open
Portal Timelines at a Glance
| Application type | NAFDAC timeline | Query response limit |
|---|---|---|
| New registration (imported drugs) | 240 working days from acceptance | 90 working days |
| Renewal (imported drugs) | 60 working days from acceptance | 45 working days |
| Reliance procedure | Decision within 60 working days | As set by the guideline |
In every case, the clock stops while a query is open. The reliance procedure applies to products approved by a stringent regulatory authority, and our comparison of WHO prequalification and NAFDAC registration explains the route for prequalified products.
After Approval: What the Portal Does Not Cover
A Certificate of Registration on NAPAMS is the start of a product's regulatory life in Nigeria, not the end. Several obligations sit alongside it:
Advertising
NAFDAC's imported drugs guideline states that registration does not include permission to advertise. Advertising needs a separate NAFDAC approval.
Variations
Changes to the product, manufacturing site or labels after approval need NAFDAC approval, and renewal applications must list the approved variations with their dates.
Certificate validity
NAFDAC may revoke, suspend or vary a certificate during its five year validity.
Pharmacovigilance
The Certificate of Registration Holder must have 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 explains those safety duties in full.
Common NAPAMS Problems
- Unauthenticated certificates: A COPP or cGMP certificate uploaded without authentication by a Nigerian mission is incomplete.
- Expired documents: A lapsed Superintendent Pharmacist licence or premises licence stops the file.
- Products grouped together: NAFDAC requires one application per product.
- Missed queries: Queries left unanswered past the limit close the application automatically.
- Treating payment as registration: A paid fee does not mean a product is registered.
- Late renewals: Starting a renewal inside the final 30 days before expiry misses NAFDAC's stated window.
- Poor scans: Illegible uploads lead to queries, so documents should be clear, complete and in the order requested.
NAPAMS Submission Checklist
- [ ] Applicant account details match CAC records
- [ ] Dossier screening clearance obtained (human medicines)
- [ ] All Step I documents current, signed, notarised and authenticated where required
- [ ] One application started per product
- [ ] Fees paid in line with the NAFDAC Tariff
- [ ] A named person checking the account for queries
- [ ] Renewal dates diarised at least 30 calendar days before expiry
- [ ] Bioequivalence or biowaiver data prepared for DMS where the product is a generic
Frequently Asked Questions
What is the NAFDAC online registration portal?
It is NAPAMS, the NAFDAC Automated Product Administration and Monitoring System, at registration.nafdac.gov.ng. NAFDAC uses it to receive and process product registration and renewal applications.
Can a foreign manufacturer open a NAPAMS account?
Registration goes through a company incorporated in Nigeria with the Corporate Affairs Commission. The foreign manufacturer authorises that company through a Power of Attorney or Contract Manufacturing Agreement.
Can I register several products in one NAPAMS application?
No. NAFDAC requires a separate application for each product.
Is everything done on the portal?
Most of the paperwork is, but registration samples are submitted physically for laboratory analysis, and NAFDAC still confirms the GMP status of the manufacturing site. Bioequivalence data for generics goes on DMS.
How do I pay NAFDAC registration fees?
Fees are set out in NAFDAC's Tariff and paid as part of the portal process. Paying a fee does not mean the product is registered.
How long do I have to answer a NAFDAC query?
90 working days for new registrations of imported drugs, and 45 working days for renewals. Unanswered applications close automatically.
When should I renew on NAPAMS?
NAFDAC's renewal guideline says renewal should start no later than 30 calendar days before the certificate expires.
Does NAFDAC issue paper certificates?
Approved products receive an electronic Certificate of Registration, valid for five years.
How MedNova Supports NAPAMS Submissions
MedNova Lifesciences provides regulatory affairs support in Nigeria for companies entering and staying on the Nigerian market. We review documents before upload, prepare and submit applications on NAPAMS, monitor accounts for queries, draft responses within NAFDAC's deadlines, coordinate sample submission and manage renewals. Registration also brings pharmacovigilance obligations, which our pharmacovigilance services and local QPPV cover. See our capability statement.
Related reading: how to register a drug with NAFDAC, the NAFDAC registration documents checklist, our NAFDAC product registration guide, the market entry and compliance overview, the complete guide to pharmacovigilance in Nigeria, and the resources library.
Next step: Contact our team to manage your NAPAMS submissions and renewals.
References
- 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).
- National Agency for Food and Drug Administration and Control. Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria (DR&R-GDL-025-01).
- 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).
- Voice of Nigeria. NAFDAC introduces online registration to manufacturers in Osun State.
- National Agency for Food and Drug Administration and Control. NAPAMS registration portal.
- National Agency for Food and Drug Administration and Control. Regulatory resources and guidelines index.
- MedNova Lifesciences. Pharmacovigilance services, Nigeria and Africa.
- MedNova Lifesciences. Regulatory affairs services, Nigeria and Africa