Registration of Foreign Cosmetics Products with NAFDAC Overview
The National Agency for Food and Drugs Administration and Control [“NAFDAC”] is the Body established by the National Assembly in Nigeria to regulate and control the manufacture, importation, exportation, advertisement, distribution, sale and use of foods, drugs, cosmetics, medical devices and chemicals. Cosmetics products are regulated by NAFDAC, hence the need for compliance with NAFDAC registration requirements.
Importance of registering foreign cosmetic products with NAFDAC in Nigeria
There are numerous reasons why an importer of cosmetics products in Nigeria should register their cosmetics products with NAFDAC, and these include:
- It is a regulatory requirement, as NAFDAC is saddled with the responsibility of regulating the manufacturing and sale of cosmetics in Nigeria.
- NAFDAC conducts quality assurance tests on these products to ensure that they are fit for the Nigerian market and won’t harm its users.
- Non-registration of cosmetics products which are imported into Nigeria, for sale to Nigerian users, can lead to criminal prosecution, a seizure of the goods, and complete removal of same from the market by NAFDAC.
Regulatory framework that governs cosmetics products in Nigeria
The following laws and regulations govern the manufacturing, importation, distribution and sale of cosmetics in Nigeria:
- National Agency for Food and Drug Administration and Control Act.
- Guidelines for Registration of Imported Cosmetics in Nigeria.
- Cosmetic Products Regulation, 2023.
- Cosmetic Products Labeling Regulation.
- Cosmetic Products Advertisement Regulation.
Key statutory requirements for imported foreign cosmetics products
As a regulatory rule, NAFDAC requires all cosmetics products imported for distribution and sale in Nigeria to be submitted for registration with NAFDAC, must meet registration requirements, have a NAFDAC number issued in respect of the products, and also meet labeling requirements post-registration.
Categories of cosmetics products regulated by NAFDAC in Nigeria
NAFDAC prescribed the following categories of products are “cosmetics” which it regulates: Skin care, Oral care, Sun care, Hair care, Decorative cosmetics, Body care, Perfumes.
Who Can Apply to Register Foreign Cosmetics Products in Nigeria with NAFDAC
The following category of persons can apply:
- The importer
- The manufacturer
What is the Regulatory Authority for Registration
The Regulator which registers foreign cosmetics products imported into Nigeria is the National Agency for Food and Drugs Administration and Control [NAFDAC].
Link to the Regulatory Authority
Interested persons can visit the NAFDAC website here: https://www.nafdac.gov.ng
Preparation for NAFDAC Registration
Eligibility Requirements for Foreign Cosmetics Products
NAFDAC did not specify any specific requirements for foreign cosmetics products sought to be registered within Nigeria. There are labeling, packaging, and quality control requirements, though, which must all be met before approval of registration.
Required Documents to be Submitted, and Information
An importer of cosmetics products into Nigeria, or its manufacturer, is required to submit the following documents to register their foreign cosmetics products with NAFDAC:
- An application letter addressed to the Director-General (NAFDAC), Attention.
- Certificate of Incorporation of Business issued by the Corporate Affairs Commission.
- Notarised Declaration to be completed (typed), signed by declarant and notarized by a Notary Public in Nigeria
- Power of Attorney: If the application is made on behalf of a foreign manufacturer by an applicant in Nigeria, such applicant must file evidence of Power of Attorney from the manufacturer which authorizes the applicant to speak for his Principal; on all matters relating to the latter’s specialties. The Power of Attorney shall (be):Issued by the manufacturer of the product, Signed by the managing director, general manager, Chairman or President of the company, stating the names of the product to be registered; State ownership of Brand Name(s)/Trademark; Notarised by a Notary Public in the country of manufacture and must also be valid for at least five years (5) years.
- Contract Manufacturing Agreement: An applicant filing an application and being the owner of Brand name/Trademark, shall provide a Contract Manufacturing Agreement, which shall be signed by the applicant and the manufacturer.
- Evidence of Registration of Brand Name with Trademark Registry in the Federal Ministry of Industry, Trade and Investment, Nigeria. This should be done in the name of the owner of the Trademark/Brand name.
- Certificate of Manufacture and Free Sale.
- Product Labels/artwork.
- Letter of Invitation for Good Manufacturing Practice (GMP)
- Comprehensive Certificate of Analysis presented on the letter-headed paper of the Quality Control Laboratory where the [cosmetic] sample was tested/evaluated.
Fees and Payment Process
Payment is made online, on a designated portal and fees are generated for each product you wish to register.
Timeline for Registration of Cosmetics Products with NAFDAC
The minimum timeline for registration of foreign cosmetics products with NAFDAC is one hundred and twenty [120] working days. The timeline could be more, depending on numerous factors like raised queries on submitted documents and approval timelines.
Ensuring Compliance with NAFDAC Regulations
Every applicant seeking to register their foreign cosmetics products with NAFDAC in Nigeria should ensure that they meet all requirements set out by the Guidelines for Registration of Imported Cosmetics in Nigeria. Failure to adhere to the guidelines can lead to rejected application, or cause delays for the applicant.
Registration Process
Gather all Necessary Documents and Make Application
The first step in the registration process is for an applicant to assemble ALL required documents which is required for registration. An applicant should ensure they get all required documentation ready before commencing registration on NAFDAC’s NAPAMS portal by submitting the entire required documents.
Issuance of Import Permit
Upon submission of the entire required documents, NAFDAC will issue an Import Permit to the applicant, a necessary next phase in the registration process.
Submission of Foreign Cosmetic Products for Laboratory Analysis
After an applicant is issued with Import Permit in respect of the cosmetics products, the next step in the registration process is for the applicant to submit the products for laboratory analysis and then submit laboratory samples. The applicant needs to submit the following documents as well: Letter of submission of products for analysis, Receipt of payment and Certificate of analysis.
Product Approval Meeting
NAFDAC will review the submitted laboratory documentation, and, upon satisfactory review, GMP inspection of the production facility and laboratory analysis of product (where applicable), the relevant products are presented for the Food and Drug Registration Committee (FDRC) Approval Meetings. It is at this phase that the cosmetics products will get approval or disapproval.
Certificate of Product Registration
When the products pass inspection and are approved, NAFDAC will then issue a Certificate of Product Registration to the applicant. The said NAFDAC Certificate of Product Registration will have a validity period of five years from time of issuance.
Labeling Requirements
NAFDAC requires cosmetics products to be labeled with information that is accurate and in conformity with NAFDAC’s Cosmetics Products Labeling Regulations. The Cosmetics Products Labeling Regulations provides extensive guidelines regarding how cosmetics products identity should appear, the information to be contained on the products labels, declarations [of manufacturer, name and address and country of manufacture] to be contained on it, among the other extensive information to be stated on the cosmetics products label. These Regulations are applicable to imported foreign cosmetics products as well.
Advertising and Promotion Guidelines
When a foreign cosmetics product is approved, with NAFDAC number issued for same, the product does not automatically gain an Advertising Permit. Cosmetics products in Nigeria fall under classes of NAFDAC-regulated products in Nigeria, and NAFDAC has Guidelines for Advertisement of NAFDAC Regulated products in Nigeria. Thus, an importer of cosmetics products needs to file a separate application for advertisement of their cosmetics products and obtain approval from the Agency.
Conclusion
Nigeria has an agile, youthful population, with money to spend on skincare. To protect Nigeria’s population, NAFDAC makes it a mandatory requirement for cosmetics importers to register their cosmetic products with the Agency. This is to ensure quality assurance, that the lineup of ingredients in the said products are not harmful to Nigeria’s end users.
If you are a cosmetics products manufacturer looking to expand your products to Nigeria, Africa’s largest market, or you are an importer seeking guidance on how to register the foreign cosmetics products you want to import with NAFDAC, we invite you to reach out to us and we will be delighted to provide additional details and guide you through the process. Kindly send an email to contact@kabbizlegal.com or call us on +234864231176, or alternatively click the link here to chat us on WhatsApp. We respond to all business enquiries within max, twenty-four hours.
This article was written as a Thought Leadership post for our Product Registration practice group at Kabbiz Legal & Advisory.
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