All hand sanitizer products that are sold in Nigeria must be registered with the National Agency for Food and Drug Administration and Control (NAFDAC). NAFDAC is an agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetic, medical devices, etc.
What Documents are Needed to Submit an Application to Register Hand Sanitizers in Nigeria
NAFDAC requires applicants to provide the following:
- Registration Form: To begin the process, an application form must be completed. NAFDAC has simplified the registration process by allowing applicants to submit their request using it’s e-registration and data capture system for product registration and renewal.
- Product Details: Applicants must provide details of the active ingredients contained in proposed products. For example, the most common active ingredient used in hand sanitizers is ethyl alcohol. Applicant’s must also identify whether or not the product contains any controlled substances. NAFDAC provides a list of over 1,000 controlled substances and ask that applicant’s identify any substance from the list.
- Manufacture’s Details: Information such as the manufacturer’s name, phone number, contact and mailing address, email, country of origin as well as the manufacturing site must be provided to NAFDAC.
- Evidence of Company Registration: NAFDAC requires proof of company registration.
- Evidence of Trademark Registration: NAFDAC accepts the Acceptance Forms issued by the Trademarks Registry in Nigeria.
- Images of the Product: NAFDAC requires that applicant’s submit images showing the front, back, inner view, side view and whole view of the product. These images can be submitted in JPEG format.
- Notarized Power of Attorney/Contract Manufacturing Agreement
- Notarized Declaration of Document by Local Applicant
- Letter of Invitation for GMP Inspection
- Evidence of Any Special Claims/Certificate of Assessment Report: It is optional to include this with the application.
- Dossier (for Test Kits Only)
- Current Good Manufacturing Practice (GMP): It is optional to include this with the application.
- Copy of Expiring Registration Certificate or License: This is to be provided in cases where the applicant seeks to renew and existing registration.
- Label of the Product or Colored Artwork: See below for more information on the label requirements.
- Certificate of Manufacture and Free Sale.
- Certificate of Analysis for Finished Product.
- Application Letter: The application should include a letter stating the purpose for product registration.
Does NAFDAC have Specific Information that Needs to be Included on Labels for Hand Sanitizer Products
Yes, NAFDAC requires that the labels of hand sanitizer products contain the following information:
- Product Name
- The Name and Full location address of the manufacturer
- Provision for NAFDAC registration number.
- Product composition (stating the volume concentration of the active ingredient)
- Date of Manufacture and Expiration Date
- Batch Number
- Storage Condition
- Net Content of the Product
Are you looking to get register hand sanitizers in Nigeria, our team of experts can assist you with NAFDAC registration. Please email email@example.com. This article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances.