How to Obtain NAFDAC Certificate of Registration
National Agency for Food Drug and Administration Control (NAFDAC) is the agency that is responsible for controlling, maintaining the distribution of transportation, advertisement, importation, exportation, manufacture and the registration of the categories of products such as drugs, consumable goods, chemicals, cosmetics, medical and biological services. And they are also the one that regulated foods, drugs, cosmetics, animal feed, veterinary, medical services, packaged water including all drinks etc.
Prior to the establishment of NAFDAC in Nigeria, so many harmful products has been in circulation in Nigeria and these have caused great damages to peoples and animals life in Nigeria.
In order to ensure that, products that are not harmful to the public are made available to the masses, Nigeria government set up a registration process that must be completed with NAFDAC by any producer, seller of foods and drugs product, importer or exporter.
Before you think of registration your products NAFDAC registration, you need to know that there are:-
Registration requirement for locally manufactured goods which is slightly different from when you are importing goods.
Also, if your company produces different products, you will need to register every one of them separately. Each products get his own NAFDAC registration number.
In obtaining the certificate of registration for your products or services from NAFDAC, you will need to first of all fill an application form which will depends on your product type or services. The form you will fill provide information on Application, Facility inspection, Documentation, Labelling, Tariff (fees) and Timelines.
You need to be aware that there are steps you need to take to kick start your product or services registration and they are:-
The first thing you will need to do, is to approach nearby zonal office of NAFDAC so as to get your factory inspected. After surpassing this phase of getting them to inspect your factory; NAFDAC will ask you to submit three samples of your products for analysis. After they have analysed it to their satisfaction, they will issue you certificate of recognition as a manufacturer.
After you are done with the first phase highlighted above, the next phase is to buy a registration form from NAFDAC and make sure they are filled appropriately. However, if you are registering more than one product, you have to purchase more than one form because, each product will have different NAFDAC registration number. Meanwhile, your application letter will be addressed to:-
Registration and Regulatory Affairs,
Central Laboratory Complex,
When you are done with the second phase, the next phase is to writing an application letter to the agency, which will state you plan to register a product. You must ensure that the application give details of your name (as a manufacturer), your product name and your brand name.
The application form you filled will be submitted alongside your completed registration form and make sure you attached all the required documents too. You need to make sure all the information given inside NAFDAC compliance directive given to you are adhere too so as to get your product register as early as possible.
Most people don’t adhere to the given guidelines in the compliance directive (CD), that’s why they used to have delay in getting their product registered or even their application can be rejected.
At this phase, you will issued a certificate of registration and NAFDAC registration number for your product; this is after a successful registration.
However, the following are required from you as an applicants for NAFDAC certificate of registration and they are:-
Submission of all documents for registration and application letter in accordance with the issued guidelines at first instance for any of the service to be rendered by NAFDAC.
Providing NAFDAC with the relevant information and description of the facility for inspection where it relates to registration and importation of NAFDAC regulated products.
Providing samples of the products to be registered when notified by NAFDAC for laboratory analysis.
Ensuring that all payments are made as at when due
Ensuring that all documents are complete and with the appropriate description to prevent unnecessary delays.
Although, NAFDAC expected you to comply with their Compliance Directive (abbreviated as CD) within 7 days of issuance. This compliance directive will tell you what and what you need to complied with for your application to be successful. And, your failure to comply with anything inside the compliance directive given to by NAFDAC may lead to the cancellation of your application and all your delays won’t be counted within 90 days for registration.
Meanwhile, you need to know that, there are timelines for the completion of application, and the timelines are:-
If you are registering a food product, the timeline for the registration is not more than 90 days starting from when your application is accepted.
If you are registering a drug product, the timeline for the registration is not more than 120 days, started from when your application is accepted.
And, if there are variation of product registration, it will takes not more than 60 days for your registration to be ready.
Furthermore, the requirements for Food products and Drug products are quiet different. Therefore, this will be highlighted below.
If you are registering for a food products, you will be required to attach the following to your application form:-
Your certificate of incorporation issued by the corporate affairs commission (CAC)
The certificate of inspection/recognition issued by NAFDAC.
Comprehensive Certificate of analysis of the batch of product submitted for registration from the manufacturer stating name and signature of the analyst.
Trade mark approval for your brand name by Federal Ministry of Commerce (where applicable).
Application form forwarded to the Director stating the name of manufacturer, brand name, and product or products (as the case may be).
And, If you are registering for a drug products, you will be required to attach the following to your application form:-
Your certificate of incorporation issued by the corporate affairs commission (CAC)
A signed and endorsed certificate of Pharmaceutical Product.
Submit three samples of your product for quality analysis and inspection.
Original copy of the Power of Attorney from the product manufacturer (if imported).
Completed NAFDAC application form.
The application letter for registration of the product.
Letter of invitation from manufacturer to inspect factory abroad, full names and site of plant.
However, if you are registering as an importer of foods or drugs products to the country, there are requirements you must adhere too and this includes:-
An applicant for a manufacturer outside Nigeria must file an evidence of Power of Attorney from the manufacturer.
You must provide evidence that the manufacturer of the imported food or drug product are licensed to sell such product in the country of origin and that the sale of the product does not constitute a contravention of the food laws of that country of origin.
Permit to import samples.
A letter of Invitation to inspect the factory abroad.
The applicant must be based in Nigeria who must have a duly signed Power of Attorney from the manufacturer authorizing the Nigerian representative to act in their capacity in Nigeria and with the name of the product explicitly stated.
In further buttressing registering as an importer of foods or drugs products. You need to know about more about some requirements and they are explained below as thus:-
Notarized Declaration: this is to be type-filled and notarized by a Notary Public here in Nigeria.
Power of Attorney or Contract Manufacturing Agreement: You must submit power of attorney or contract manufacturing agreement from the manufacturer authorizing the Nigerian representative to act in their capacity in Nigeria. The Director or President of the Company must sign this document. The document must state the names of the products to be registered or imported into Nigeria. It must also states the ownership of brand names/trademark of the product. The power of attorney or contract manufacturing agreement is to be notarized by the Notary public in the country of the manufacturer.
Certificate of Free Sale: a relevant health/regulatory body in the manufacturer’s country indicating the name of the Manufacturer and products to be registered issues this document. It is also to be authenticated by the Nigerian Embassy in the country of origin. In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate the document.
Comprehensive Certificate of Analysis: The Certificate of analysis must be presented on a letter headed paper of the quality control laboratory where the sample was tested or evaluated and it should contain the following;
1. The analysis of the product or goods
2. The batch number of the product
3. The manufacturing and expiry dates
4. The name, designation and signature of the analyst
Certificate of Business Incorporation of the Importing Company with the Corporate Affairs Commission in Nigeria.
Certificate of Registration of Brand Name with the trademark registry
Application letter for Import Permit by the applicant (i.e. Local Agent).
Duly completed Registration Form online.
Coloured Artwork/Label of the product and leaflet insert of the product.
Evidence of GMP inspection by NAFDAC.
GMP Invitation letter: This is a letter of invitation to inspect the factory abroad shall be written by the manufacturer and shall state the following:
Manufacturer Information: 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
Local Agent’s Information: Name of the company, full location address and functional telephone no, fax no. & email address. Name(s) of the product(s) for registration, name & mobile phone no. of the contact person in Nigeria
After documentation satisfaction, import permit to import samples for registration shall be obtained from the respective units after payment. The product(s) to be registered must also be brought in samples for sample vetting by the agency upon registration and the following documents are required for the sample vetting.
About the Writer
Olusipe Abiodun Yinka is an Audit Associate in Bulls Capital Limited. He has a National Diploma in Accounting from Abraham Adesanya Polytechnic, Ijebu-Igbo, Ogun State; as well as a Degree in Accounting from Alex Ekwueme Federal University, Ebonyi State. He is a creative writer and a Trendsetter. Apart from writing, Olusipe is also an entertainer.
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