How NAFDAC organises registration documents
NAFDAC's registration process runs in stages, and each stage asks for its own documents. Our step by step guide on how to register a drug with NAFDAC explains the full process. This article focuses on the paperwork: what each document is, who issues it and what NAFDAC checks.
The documents fall into five groups:
- Corporate and legal documents that prove who the applicant is and its right to register the product
- Manufacturer certificates issued in the country of manufacture
- The GMP inspection invitation letter
- The technical dossier in CTD format
- Labelling, and the documents that accompany registration samples
All Step I documents are uploaded to NAFDAC's NAPAMS portal at registration.nafdac.gov.ng, with one application per product. NAFDAC may ask to see the originals at any time.
Group 1: Corporate and legal documents
These documents establish the Nigerian applicant and its authority over the product.
| Document | What NAFDAC requires |
|---|---|
| Dossier screening clearance | Clearance of the dossier at screening. For human medicines this is a prerequisite before the application proceeds. |
| Application letter | Addressed to the Director General of NAFDAC, for the attention of the Director, Drug Registration and Regulatory Affairs. |
| Notarised declaration | Typed, signed by the declarant and notarised by a Notary Public in Nigeria, in the format of the guideline's Appendix I. It covers trademark ownership, generic status and indemnity, and makes false declarations a criminal liability. |
| Power of Attorney | Required where the applicant does not own the brand. Issued by the manufacturer, signed by its MD, GM, Chairman or President, naming the products, stating the authority to register them with NAFDAC and who owns the brand, notarised in the country of manufacture and valid for at least five years. |
| Contract Manufacturing Agreement | Required where the applicant owns the brand and another company manufactures it. Notarised in the country of manufacture, signed by both parties with names and designations, naming every product, with clear clauses. |
| CAC incorporation | Evidence that the applicant is incorporated with the Corporate Affairs Commission in Nigeria. |
| Trademark registration | Evidence that the brand name is registered with the Trademark Registry of the Federal Ministry of Industry, Trade and Investment, in the owner's name, under Class 5. |
| Superintendent Pharmacist's licence | A copy of the current annual licence issued by the Pharmacists Council of Nigeria. |
| Premises retention licence | A valid retention licence for the applicant's premises. |
Most early queries trace back to this group. A Power of Attorney that leaves out the product names, or runs for less than five years, does not meet the guideline. Our registration preparation guide explains how to set up the applicant company before filing.
Group 2: Manufacturer certificates
These documents come from the regulatory authority in the country where the product is made.
Manufacturing Licence or Certificate of Free Sale
Issued by the health or regulatory authority in the country of manufacture, showing that the manufacturer is licensed or that the product is freely sold there.
Certificate of Pharmaceutical Product
The Certificate of Pharmaceutical Product (COPP) must follow the WHO format and be issued by the regulatory authority in the country of manufacture. It must be authenticated by the Nigerian Embassy or High Commission in the country of origin. Where Nigeria has no mission in that country, authentication by a mission of a Commonwealth or ECOWAS country is accepted.
cGMP Certificate
A current Good Manufacturing Practice certificate for the manufacturing facility, issued by the regulatory authority in the country of manufacture. It must be valid at the time of submission and authenticated in the same way as the COPP.
For products that already hold WHO prequalification or stringent authority approval, see our comparison of WHO prequalification and NAFDAC registration.
Group 3: The GMP inspection invitation letter
NAFDAC must confirm the GMP status of the manufacturing site, and for overseas factories the process starts with an invitation letter written by the manufacturer. Under the guideline, the letter must contain:
- The manufacturer's company name and factory address (the factory, not the administrative office)
- The manufacturer's email address and telephone number
- The name, telephone number and email address of the overseas contact person
- The local agent's company name, address, functional telephone number and email address
- The local agent's contact person and the names of the products
The inspection itself is handled by NAFDAC's Drug Evaluation and Research Directorate.
Group 4: The CTD dossier, Modules 1 to 5
NAFDAC requires the technical dossier in Common Technical Document format for every risk category, according to its risk categorisation guideline (Doc. Ref. DR&R-GDL-033-01). NAFDAC's CTD quality guideline (Doc. Ref. R&R-GDL-O18-OO) sets out the structure.
Administrative and Product Information
Module 1 is the regional module, holding Nigeria-specific content. It includes a cover letter, a table of contents for Modules 1 to 5, application information, and product information: the Summary of Product Characteristics, inner and outer labels, and the Patient Information Leaflet. It also carries regional summaries, such as the Bioequivalence Trial Information Form and the Quality Information Summary, electronic review documents and samples information. Nigerian administrative documents, such as the notarised declaration, the Superintendent Pharmacist's licence, the premises certificate, the GMP invitation letter, the COPP and GMP certificate and trademark evidence, also belong here.
CTD Summaries
Module 2 holds the Quality Overall Summary, plus the nonclinical and clinical overviews and summaries. NAFDAC's guideline notes that the nonclinical and clinical parts of Module 2 are usually not needed for multisource (generic) products.
Quality
Module 3 holds the full quality data for the drug substance and the finished product: manufacture, controls, specifications, container closure and stability. NAFDAC's guideline refers to ICH guidance, including ICH Q1A(R2) on stability testing. Proposed storage conditions, shelf life and supporting stability data are summarised in the Quality Overall Summary. Nigeria falls in WHO climatic zone IVb (hot and very humid), which matters when choosing the stability data to submit.
Nonclinical and Clinical Study Reports
Module 4 holds nonclinical study reports and Module 5 clinical study reports. Which reports are needed depends on the product:
- New chemical entities: clinical trial reports from the relevant population.
- Generic products: a bioequivalence study report or biowaiver data, submitted in CTD format on NAFDAC's DMS.
- Fixed dose combinations: documented evidence of clinical advantage over the single drugs.
NAFDAC is a full ICH member, and the CTD structure follows ICH M4. Our article on ICH guidelines compared with NAFDAC requirements covers how ICH standards apply in Nigeria.
Group 5: Labelling and sample documents
Labelling requirements
Labels and leaflets are reviewed before NAFDAC issues the permit to import registration samples. Under the guideline, labels must show:
- Brand name where applicable, with the generic name conspicuous and directly beneath it
- Manufacturer's name and full address
- Space for the NAFDAC registration number
- Batch number, manufacturing date and expiry date
- Dosage form and strength, with active ingredients listed quantitatively per unit dose
- Net content, storage conditions and warnings where necessary
- Indications and dosage regimen on the pack for over-the-counter products
- A Patient Information Leaflet, and prescribing information for prescription only medicines
- An English translation on the label and leaflet where the original is in another language
- Withdrawal period for veterinary drugs
A product name that closely resembles an already registered product is not eligible.
Documents for registration samples
Once the permit is issued, samples are imported and submitted for laboratory analysis with:
- A sample submission letter
- Evidence of payment of the processing fee
- A Certificate of Analysis on the letterhead of the testing quality control laboratory, showing the brand name, batch number, manufacturing and expiry dates, and the analyst's name, designation and signature
- A copy of the permit to import registration samples
NAFDAC's CTD guideline asks for samples in the packaging intended for the market. Mock-up packaging can be used where final packaging is not yet available, and the cover letter states the number of samples submitted.
Additional documents for reliance and high-risk dossiers
Products already approved by a stringent regulatory authority can use NAFDAC's reliance procedure (Doc. Ref. DR&R-GDL-035-00). The applicant submits complete, unredacted assessment reports from the reference authority and must show the product is the same as the one approved there: same manufacturing chain, specifications, product information and indications.
At the other end of the scale, high risk dossiers, such as new molecules or products from new manufacturers outside stringent authority regions, need a pre-submission meeting with NAFDAC and receive a full dossier review.
Validity dates to track
Several documents expire, and an expired document stops an application. Key validity rules in NAFDAC's guideline:
| Document | Validity rule |
|---|---|
| Power of Attorney | At least five years |
| cGMP certificate | Valid at the time of submission |
| Superintendent Pharmacist's licence | Annual licence, must be current |
| Premises retention licence | Must be valid |
| Certificate of Registration (once issued) | Five years, then renewal |
The timeline matters too. NAFDAC's guideline sets 240 working days from acceptance to issue of the registration number, with the clock stopped while queries are open. Queries must be answered within 90 working days, or the application closes automatically. Applicants that keep documents current answer queries faster.
NAFDAC registration documents checklist
Use this checklist before submitting on NAPAMS.
Corporate and legal
- Dossier screening clearance
- Application letter to the Director General
- Notarised declaration (Appendix I format)
- Power of Attorney or Contract Manufacturing Agreement, notarised in the country of manufacture
- CAC certificate of incorporation
- Trademark registration, Class 5, in the owner's name
- Superintendent Pharmacist's current PCN licence
- Premises retention licence
Manufacturer certificates
- Manufacturing licence or Certificate of Free Sale
- COPP in WHO format, authenticated by a Nigerian mission
- cGMP certificate, valid and authenticated
- GMP inspection invitation letter with all required details
CTD dossier
- Module 1: Cover letter, application information, SmPC, labels, PIL, regional summaries
- Module 2: Quality Overall Summary (plus nonclinical and clinical summaries where required)
- Module 3: Drug substance and finished product quality data, including stability
- Module 4: Nonclinical study reports where required
- Module 5: Bioequivalence report or biowaiver data for generics, clinical trial reports for new chemical entities
Labelling and samples
- Labels checked against every NAFDAC labelling requirement
- English translation where needed
- Permit to import registration samples
- Sample submission letter and evidence of fee payment
- Certificate of Analysis with all required details
Missing something, or not sure a document meets the guideline? Ask our regulatory team for a document readiness review.
Frequently asked questions
What documents are required for NAFDAC registration?
For imported drugs: dossier screening clearance, an application letter, a notarised declaration, a Power of Attorney or Contract Manufacturing Agreement, CAC incorporation, a manufacturing licence or Certificate of Free Sale, an authenticated COPP and cGMP certificate, trademark registration, the Superintendent Pharmacist's licence, the premises retention licence, a GMP inspection invitation letter, a CTD dossier, compliant labels and sample documents.
Does NAFDAC require a CTD dossier?
Yes. NAFDAC's risk categorisation guideline requires a dossier in CTD format for low, medium and high risk products.
What is a COPP and does it need authentication?
A Certificate of Pharmaceutical Product is a WHO format certificate from the regulator in the country of manufacture. NAFDAC requires it to be authenticated by the Nigerian Embassy or High Commission in that country, or by a Commonwealth or ECOWAS mission where Nigeria has none.
How long must a Power of Attorney be valid for NAFDAC?
At least five years. It must also name the products, state the authority to register them and who owns the brand, and be notarised in the country of manufacture.
Who issues the trademark evidence NAFDAC asks for?
The Trademark Registry of the Federal Ministry of Industry, Trade and Investment. The brand must be registered in the owner's name under Class 5.
Do generic medicines need bioequivalence data?
Yes. Generics need a bioequivalence study report or biowaiver data, submitted in CTD format.
Where are NAFDAC registration documents submitted?
On NAFDAC's NAPAMS portal at registration.nafdac.gov.ng, with one application per product.
What must a Certificate of Analysis show?
The brand name, batch number, manufacturing and expiry dates, and the analyst's name, designation and signature, on the testing laboratory's letterhead.
How MedNova supports your NAFDAC submission
MedNova Lifesciences provides regulatory affairs support in Nigeria, covering document gap reviews, Power of Attorney and declaration drafting, COPP and GMP authentication tracking, CTD dossier compilation, label review, NAPAMS submissions and query responses. Registration also brings pharmacovigilance duties, and our pharmacovigilance services, including a local QPPV, cover those under the same partner. See our capability statement.
Related reading: how to register a drug with NAFDAC, 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 for a document readiness review before you file.
Getting your NAFDAC documents ready?
MedNova Lifesciences reviews document gaps, drafts Powers of Attorney and declarations, tracks COPP and GMP authentication, compiles CTD dossiers and answers NAFDAC queries, with pharmacovigilance and QPPV cover from the same team.
Contact MedNova LifesciencesRelated resources
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). nafdac.gov.ng
- National Agency for Food and Drug Administration and Control. Quality Guidelines for the Registration of Pharmaceutical Products for Human Use in Nigeria: Guidance for the Preparation of Applications in the CTD Format (R&R-GDL-O18-OO). policyvault.africa
- 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
- 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
- National Agency for Food and Drug Administration and Control. NAPAMS registration portal. registration.nafdac.gov.ng
- 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.
- MedNova Lifesciences. Pharmacovigilance services, Nigeria and Africa. mednovalife.com/pv.html
- MedNova Lifesciences. Regulatory affairs services, Nigeria and Africa. mednovalife.com/regulatory.html