Process for Cosmetic Product Registration in Nigeria
Cosmetic product registration in Nigeria is the responsibility of the National Agency for Food and Drugs Administration and Control (NAFDAC). It is an organisation responsible for controlling, maintaining the distribution of transportation, advertisement, exportation, importation, manufacture and the registration of the categories of products such as drugs, chemicals, consumable goods, cosmetics, biological, and medical services. The NAFDAC Requirements for production or importation of food, drugs or consumable goods in Nigeria depend on whether such items are produced locally or abroad.
Under the law establishing NAFDAC it is unlawful to market any drugs or consumable goods in Nigeria to the public without due registration with the NAFDAC. If any company is set up in Nigeria for the purpose of the importation or manufacturing of food or drugs or consumable products, all the products produced by such a company must be registered with the NAFDAC. Please note that if your company produces different products, you will need to register each of them separately.
Classification of Businesses
For the purposes of registration, NAFDAC classifies businesses into three broad categories – Micro business, small scale businesses, and medium/large scale businesses. The classification of those businesses is based on the number of employees which the business has:
- Micro Enterprises: Less than 10 employees
- Small Enterprises: 10-49 employees
- Medium/Large Enterprises: 50-199
Application Process for Cosmetic Products in Nigeria
Step 1 – Application
In order to register your locally made cosmetic product you will need to make an application to NAFDAC including the following information:
Certificate of Incorporation or registration of business name – only registered business entities apply for registration of a cosmetic product in Nigeria, applicants cannot do so in their individual capacity. Therefore you have to register your business either as a limited liability company or as a business name first. We suggest that you register as a limited liability company, you can find out more about the difference between both business structures here – LLC v Business Name
Trademark Certificate/Acceptance Letter – NAFDAC requires that before you register a cosmetic product you must have applied to the Trademark Registry for the registration of the trademark of your brand name. You can find out more about the Trademark registration process here – How to Register your Trademark in Nigeria
Comprehensive Certificate of Analysis – this a document issued by a laboratory that confirms that a regulated product meets its product specification. They commonly contain the actual results obtained from testing performed as part of quality control of an individual batch of a product.
Proposed Label – NAFDAC requires that the proposed label of the cosmetic product be included with the application, there are specific requirements on what must be on the label and what information can be used to explain the benefits of the product. Where this information is not included, a compliance query will be issued on the application, and the applicant must amend the label before the application can be approved.
Payment of Application Fee – different products have different application tariffs, therefore applicants must pay the appropriate tariff for their product, and then include evidence of payment with their application.
- Micro Enterprise – N22,000
- Small – N66,000
- Medium/Large – N85,000
Step 2 – Facility Inspection
If this is the first cosmetic product you are registering with NAFDAC, they will need to inspect the facility where the cosmetics are being manufactured in order to ensure they required standards. Once this is done, NAFDAC issues a Good Manufacturing Practice Certificate. This Certificate is for the facility and therefore once it has been granted, the Certificate can be used for subsequent applications while the Certificate is still valid. The official fee for the facility inspection for a cosmetic product is as below:
- Micro enterprise – N15,000
- Small Scale – N30,000
- Medium/Large Scale – N40,000
Please note that all the fees are renewable annually.
Step 3 – Approval
If all the documentation provided is satisfactory and there are no queries or issues with the information, then NAFDAC issues a Notification of Product Registration for the product. This is a temporary letter which states that the product has been approved for registration and then subsequently a Certificate of Product Registration is issued.
Consequences of Non-registration
Non-registration of products is a violation of the NAFDAC Act, and violators will have all the unregistered products confiscated, and are liable to pay penalties. These penalties are based on the classification of the business.
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We hope you have found this information helpful. Please note that this information is provided for general informational purposes only and is not intended to be legal advice. No lawyer-client relationship is formed nor should any such relationship be implied. It is not intended to substitute for the advice of a qualified lawyer. If you require legal advice, please consult with a qualified lawyer.