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.

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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.