NAFDAC Registration In Nigeria: A Step-by-Step Guide To Product Approval

Nigeria's Federal Ministry of Health oversees the National Agency for Food and Drug Administration and Control (NAFDAC), a federal agency that regulates and controls the production, importation, exportation, marketing, distribution, sale, and use of cosmetics, medications, packaged water, medical devices, and food¹

This organization is in charge of regulating and guaranteeing the quality, safety, and effectiveness of medications, food, cosmetics, and medical equipment. Unregistered products being circulated in the market have several consequences including loss of consumer trust, sanctions, scrutiny, legal penalties, and health hazards². To avoid situations that may lead to these, listed below are procedures for NAFDAC registration in Nigeria³:

1. Preparation of required documents: To ensure a seamless registration process, it is smarter and time effective to gather the required documents for registration. These documents include but are not limited to product information, purpose, formulation details, dosage and administrations, labeling information, certificates, and other approvals.
2. Creation of an account on NAFDAC's Portal: Open the NAFDAC Regulatory Information System (NAFDAC-RIS) platform and register on the NAFDAC website.
3. Submission of Application: In the first instance, submit all registration and application letter materials in compliance with the rules set for any services that NAFDAC will provide. Complete the online application form, ensuring all information is accurate and comprehensive.
4. Provide NAFDAC with the relevant information and description of the facility for inspection relating to the registration and importation of NAFDAC-regulated products.
5. Provide samples of the products to be registered when notified by NAFDAC for laboratory analysis.
6. Fee Payment: In order to register, you must pay the required fees. Generally, NAFDAC-specified online payment methods or designated banks can be used to make payments.
7. Application Review: Your application will be examined by NAFDAC. This could entail reviewing the filed paperwork and, if necessary, carrying out further assessments or inspections of the production plant.
8. Inspection (if applicable): To make sure that regulatory standards are being followed, NAFDAC may inspect the production site. During the inspection, be ready to grant access to the building and the appropriate personnel.
9. Timely Response to queries: Throughout the evaluation process, NAFDAC may issue requests for more information or queries. Answer any question completely and in a timely manner.
10. Permission and Registration Number Issue: Following approval, a registration number is issued by NAFDAC, which is necessary for the product's lawful distribution and sale in Nigeria. NAFDAC will provide a registration number if your application is accepted. The product label must display this number.
11. Post-Registration Compliance: Continue to abide by NAFDAC rules even after registering. This entails following quality standards, labeling products appropriately, and disclosing any modifications to manufacturing or formulation procedures. Remember when your registration expires, and take the necessary steps to renew it. Any major modification to your product or production procedures should also be communicated to NAFDAC.

It should be noted that there are different timelines for the registration and the timeline is dependent on the product being registered. The timeline for registration of food upon acceptance of application is 90 days while that of drugs is 120 days. Variation of product registration takes not more than 60 days. This procedure guarantees that items fulfill the required requirements and contribute to the protection of public health.

Footnotes

1. Ojonugwa, A.F., Gwom, D. and Gwom, S., 2021. The Role and Challenges of the National Agency for Food and Drug Administration and Regulation of Alternative Medicine in Nigeria. World Health.

2. Ibrahim, I.A. and Abidemi, A.M., NAFDAC INFORMATION SYSTEM FOR PRODUCT REGISTRATION.

3. https://nafdac.gov.ng/our-services/product-registrationevaluation/ accessed on the 31^st of October, 2024 at 1.48 pm.

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.