What to Know About Registering a Drug/Pharmaceutical Product with the NAFDAC

Do you have drugs or pharmaceutical products that you want to import or manufacture to sell in Nigeria? Then you need to know that, registering the drug or pharmaceutical product with NAFDAC is an important step before you can sell the products in Nigeria.

The registration process ensures that your drug products whether for human or veterinary use, imported to or manufactured in Nigeria comply with key regulations and are safe for public use. In this article, we cover the steps to getting your products registered with the NAFDAC, from application to obtaining approval, to timeline for registration as well as the costs involved.

Procedure on how to register drugs or pharmaceutical products with NAFDAC

Step 1

Purchase, complete and print out the online Registration Form from the NAFDAC Website Some of the information required for completing the form includes;

• Manufacturer Information such as Name of the Company, full location address of the factory, email address, and current phone no. & fax no, the name of contact person overseas, telephone no, email address. Name of airport closest to the location and guide map illustrating the shortest land/air route to the factory overseas (where applicable)
• Company’s Tax Identification Number, where applicable
• Details of Applicant, such as name, contact, address, qualification, job title, warehouse address, etc.
• Number of drug products
• Particulars and description of the drug product (s)
• Names of four 4 staffs including production manager, production staff, quality control and marketing director, where applicable.

Note that a separate registration form is to be completed for different drug product applications. Also, ensure that the particulars of the drug product are detailed enough to cater for all necessary administrative and technical information.

For imported drug products, the applicant is expected to submit a dossier of the drug product for screening. Dossier clearance is a prerequisite for submission of applications for pharmaceuticals for human use.

Step 2

Prepare the following documents and add them to the application as attachments:

1. An application letter addressed to the Director-General of NAFDAC but Attention of the Director of Drugs Registration and Regulatory Affairs Directorate.
2. Certificate of Incorporation from the Corporate Affairs Commission of Nigeria.
3. Contract Manufacturing Agreement, where applicable.
4. Power of Attorney (POA), if applying on behalf of a manufacturer outside Nigeria. The POA should be valid for at least 5 years and must be signed by a senior company official. It must also be notarized in the country of manufacture; state the authority to register the product with NAFDAC and indicate ownership of the brand name or trademark.
5. Dossier Screening Clearance, where applicable.
6. Trademark Certificate with the Trademark Registry in the Ministry of Industry, Trade and Investment. The trademark should be done in the name of the owner of the Trademark/Brand name, as the case may be (Trademark Class 5 for drugs).
7. A copy of the valid annual license to practice for the superintendent Pharmacist (for human or veterinary drugs) issued by Pharmacist Council of Nigeria.
8. Copy of valid Premises Retention License for the facility.
9. Evidence of satisfactory Inspection issued by the relevant Directorate or Good Manufacturing Practice (GMP) Certificate for product line (companies with registered products.
10. Label or Art work of the product which should itself comply with the Drug and Related Product Labelling requirements.
11. Certificate of Pharmaceutical product (CoPP) in the (CoPP-WHO) Format. This document is required for imported drug products. The CoPP must also be issued by the Health/Regulatory body in the country of manufacture and authenticated by the Nigerian Embassy or High Commission in the country of origin. In countries where no Nigerian Embassy exists, any Commonwealth or ECOWAS country can authenticate the CoPP.
12. A letter of invitation for Good Manufacturing Practices inspection for inspection of production facility, whether abroad or in Nigeria.

For pharmaceutical products:

1. Copy of Certificate of Suitability of the European Pharmacopoeia (where applicable).
2. Letter of Access for Active Pharmaceutical Ingredient Master File(s) (where applicable)
3. Biowaiver Request in relation to conducting BCS-based bioavailability study.
4. Biowaiver request in relation to conducting Additional Strength bioavailability study.

Step 3

A facility inspection is carried out following an invitation by the Applicant. The invitation must detail the following:

1. Name of Company (both Manufacturer and/or Local Agent)
2. Full location address of factory (not administrative office address)
3. E-mail and current Phone number.
4. Details (name, phone number and email) of contact person overseas, where applicable.
5. Name(s) of product(s) for registration.

Step 4

Samples of labels are vetted to ensure that they meet the standard requirements. Upon satisfactory review of submitted documents and label, permit to import registration sample shall be issued, for imported drug products.

Step 5

After a review of the application and attached documents, samples are presented for laboratory analysis. The samples should be accompanied with the following documents:

1. Letter for submission of laboratory samples
2. Evidence of payment of processing fee
3. Certificate of Analysis. The Certificate of Analysis must be presented on a letter-headed paper of the quality control laboratory where the sample was tested/evaluated and should contain the under listed information:
4. the brand name of the product
5. the batch number of the product
6. the manufacturing and expiry dates
7. the name, designation, and signature of the analyst
8. A copy of permit to import registration samples, where applicable.

Step 6

Following a successful laboratory analysis of the products, the Food and Drug Registration Committee (FDRC) will review the dossier, GMP inspection results, and laboratory analysis. Upon approval, an electronic Certificate of Product Registration or Listing is issued. A Certificate of Product Registration is valid for 5 years and renewable subsequently.

NAFDAC Labelling Requirements for Drugs/Pharmaceutical Products

Labels of any drug/pharmaceutical products are required to be in English. If the label is not in a foreign language, then you need to translate it into English; the information on the label must be informative; accurate; and must include:

1. Product Name: Both brand and generic names.
2. Manufacturer Information: Full address.
3. NAFDAC Registration Number Provision
4. Batch, Manufacturing, and Expiry Dates
5. Dosage Form & Strength
6. Usage Instructions: For Over the Counter (OTC) drugs.
7. Patient Information Leaflet (PIL)
8. Prescribing Information: For prescription-only medicines.
9. Net Content and Active Ingredients
10. Warnings and Storage Conditions
11. Veterinary Drug Withdrawal Period

NAFDAC Clinical Trials for Drugs/Pharmaceutical Products

New medicines, drugs, otherwise referred to as Investigational Medicinal Product (IMP) must be proven to be safe and effective for people before NAFDAC can approve them and doctors can prescribe them to patients. Clinical Trials are therefore, necessary for testing or studying a drug or medical device to see if it is a safe and effective treatment for people, usually following a clinical research. For example, a clinical trial may test the effectiveness of a new drug for treating Parkinson’s disease. NAFDAC has strict rules that govern how clinical trials are conducted. These rules are designed to ensure the safety of those who participate.

What Documents are Needed for Clinical Trials in Nigeria?

To conduct clinical trials in Nigeria, NAFDAC requires several key documents. These include:

1. Clinical Trial Application Form (CTAF): This must be filled and submitted online and is available on the NAFDAC website.
2. Study Protocol showing the detailed plan of the clinical trial.
3. Informed Consent Form (ICF): A document that explains the trial to participants and obtains their consent.
4. Patient Information Leaflet (PIL): Information for participants about the study.
5. Investigator’s Brochure (IB): Contains relevant clinical and non-clinical data on the investigational product.
6. Evidence of Agreement: Between the sponsor and the investigator.
7. Ethics Committee Approval: From accredited institutions and a list of committee members.
8. Investigator’s Curriculum Vitae (CV) and evidence of Good Clinical Practice (GCP) training.
9. Insurance Cover: For participants.
10. Data Safety Monitoring Board (DSMB) details and financial disclosures.

How Much Does It Cost to Register Drugs or Pharmaceutical Products in Nigeria

Below is a breakdown of the government Charges applicable for product registration:

1. Facility Inspection (Per Line for Local Facilities) –
2. Pre-Production: Small Scale N50,000.00
3. Pre-Production: Medium/Large Scale N70,000.00
4. Production: Medium/Large Scale (Renewable yearly) N170,000.00

Per Site for Foreign — $10,989.01

1. Port Inspections
2. Donated Drugs – N37,500.00
3. Registered Orphan Drugs/Antiretrovirals/ Vaccines – N13,500.00
4. Registered Over the Counter Drugs – N148,500.00
5. Registered Prescription Only Medicines – N40,000
6. Application Form – N2500.00
7. Clinical Trials
8. Application Fee
9. Industry Sponsored/Locally-developed IMP – N250,000.00
10. Industry Sponsored/Imported IMP — $1923.00
11. Academic Trials (Individual Self-Funded/local) – N50,000.00

(Institutional Grant Aided) – N300,000.00

1. Extension of Study (Locally Developed IMP) – N350,000.00

(imported IMP) – $2,747.25

(Academic Trials) – N20,000.00

1. Inspections
2. Institutional Grant Aided (Academic Trials) – N300,000.00
3. Additional Site (Locally developed IMP) – N150,000.00

(Imported IMP) — $415.00

(Academic Trials) – N150,000.00

1. Substantial Protocol Amendment
2. Industry Sponsored/Locally-developed IMP – N50,000.00
3. Industry Sponsored/Imported IMP — $412.09

How Long Does It Take to Register Drugs and Pharmaceutical products

The timeline for registering a drugs and pharmaceutical products with NAFDAC and applying for clinical trials varies. The factors that will determine the duration includes, the completeness of the application and compliance with regulatory requirements. In summary, drug/pharmaceutical product registration may take 6-12 months, and clinical trial approval takes about 2-3 months to begin the trial.

Conclusion

As a manufacturer/pharmacist, NAFDAC drug product registration gives you the right to legally sell and distribute your drug products within the Nigerian market and beyond. Proper preparation and following NAFDAC’s guidelines can help speed up the process.

Kindly reach out for more detailed and expert guidance.

Also read on the NAFDAC labelling requirements for drugs and pharmaceutical products in Nigeria