A Step-by-Step Guide to Registering Your Product With NAFDAC and How Much It Will Cost You

Are you planning to release a product into the Nigerian market? Have you been wondering what it will cost to register with the National Agency for Food and Drug Administration and Control (NAFDAC)? NAFDAC registration is essential before any product can be released into the Nigerian market. The process and cost of registering a product with NAFDAC can seem daunting, but with the right information, you can confidently register your product with the agency. Let’s take a look at the cost of registering a product with NAFDAC and other details you need to know.

What is NAFDAC?

The National Agency for Food and Drug Administration and Control (NAFDAC) is a regulatory body responsible for protecting the health of Nigerian citizens through the regulation of food, drugs and medical devices. It is part of the Federal Ministry of Health and its primary role is to ensure that food, drugs and medical devices are safe for use and effective in treating illnesses. NAFDAC was established in 2003 to take over from the National Drugs and Pharmaceuticals Administration (NDPA). Prior to 2003, the control and regulation of drug manufacturing, importation and distribution in Nigeria was the responsibility of the NDPA. However, the NDPA was not able to adequately regulate the country’s drug and pharmaceutical industries. As a result, the NDPA was merged with the National Food and Drug Control Board to form NAFDAC. This merger allowed NAFDAC to improve regulation and strengthen control over the industries of drugs, pharmaceuticals and foods. It also resulted in the creation of a more risk-based approach to regulation. NAFDAC has a wide range of responsibilities, including the registration of products and businesses, the control of food importation, and the provision of drug testing services.

Why is registering with NAFDAC important?

NAFDAC registration is an important step before releasing a product into the Nigerian market. It ensures that the product is safe for use and complies with the regulatory requirements for the industry in which it will be used. This means that businesses that have products that fall under the jurisdiction of NAFDAC are required to register with the regulatory body. Registration is important because it allows businesses to import and distribute their products in Nigeria. Without registration, it is illegal for products to be sold in the country. Registration with NAFDAC also allows manufacturers to export their products to other countries. Many of the major trade partners of Nigeria have similar regulatory requirements to NAFDAC. This means that products that have been successfully registered with NAFDAC can be exported to other countries without further regulatory assessment.

What are the stages of registering with NAFDAC?

The stages of registering with NAFDAC largely depend on the type of product you are registering. However, there are some general guidelines that apply to all types of products. When registering a product with NAFDAC, there are three main stages that you will need to go through. These are pre-registration, formal registration, and post-registration. Pre-registration is the process of gathering information about your product and the regulatory requirements for your industry. This stage is important because it allows you to research the regulatory requirements for your product before you actually register it. This will help you to save time and money during the formal registration process. • Formal registration is the process of submitting the necessary documentation to NAFDAC for your product. This is the stage where you will submit all of the required documents, including your Standard Manufacturing Authorisation (SMA) application, product sample information, and a product dossier. • Post-registration is the period after you have successfully registered your product with NAFDAC. This is when you will receive your Standard Manufacturing Authorisation (SMA) and will have a valid license to sell your product in Nigeria.

What documentation is required for NAFDAC registration?

The documentation that you need to submit for NAFDAC registration will largely depend on what type of product you are registering. The type of product that you are registering will also determine the level of risk associated with the product. Each product group has its own set of requirements, and the level of risk associated with each product group varies greatly. Product groups 1-3 are considered to be low-risk products, while product groups 4-8 are considered to be high-risk products.

How much does it cost to register with NAFDAC?

The cost of registering a product with NAFDAC will depend on the type of product you are registering. It also depends on the product group that your product falls under. There are a total of 10 product groups and each product group has a specific fee associated with it. Product Group 1 – Biocides, pesticides, disinfectants and similar products, herbicides, and veterinary medicinal products: N100,000.00 Product Group 2 – Foodstuffs and beverages, including infant foods and infant formulae, nutritional and dietary supplements, vitamins and minerals, herbal products, traditional foods and medicines, and other related products: N50,000.00 Product Group 3 – Pharmaceuticals: N100,000.00 Product Group 4 – Cosmetics, toiletries and other products for personal use: N150,000.00 Product Group 5 – Diagnostic kits and reagents, and other products for laboratory use: N150,000.00 Product Group 6 – Diagnostic equipment: N250,000.00 Product Group 7 – Medical devices: N200,000.00 Product Group 8 – Medical equipment: N300,000.00 Product Group 9 – Veterinary medicinal products: N100,000.00 Product Group 10 – Feed additives: N50,000.00

How long does it take to register a product with NAFDAC?

The length of time that it takes to register a product with NAFDAC will depend on the type of product you are registering. However, the general guideline is that it takes an average of 90 days to register a product. This does not include the time it will take for the documents to be reviewed, or for you to make any necessary changes. Once the documents are submitted, you should expect it to take approximately 90 days for NAFDAC to issue your SMA.

Tips for a successful NAFDAC registration

– Research the regulatory requirements for your product – Before you even start to think about registering with NAFDAC, you need to be fully aware of the regulatory requirements for your product. This will help you to avoid unnecessary delays and complications when you are submitting your documents to the regulatory body. – Familiarise yourself with the product groups – There are 10 product groups and each product group has its own set of requirements. It is important to identify the product group that your product falls under and to be aware of the requirements for that particular product group. – Get assistance if you need it – If you feel like you don’t have the expertise required to successfully complete the NAFDAC registration process, it is okay to get some help. There are various companies that offer assistance with NAFDAC registration, so you can take advantage of their expertise. – Be patient – The whole process can be quite stressful, especially if you are under a tight deadline. Make sure that you are prepared and that you know exactly what you need to do to successfully complete the registration process.

What happens after registration?

After you’ve successfully registered your product with NAFDAC, you will be issued with a Standard Manufacturing Authorisation (SMA). This is a certificate that will confirm that your product has been successfully registered with the regulatory body. The SMA will allow you to distribute your product in Nigeria and will also allow you to export your product to other countries that use the same regulatory standard. The SMA also allows you to change your manufacturing location and addresses at any time. This is particularly useful if you have offices in more than one country. It will also enable you to replace faulty products or alter your product recipe without having to re-register your product.

What are the consequences of not registering with NAFDAC?

If you fail to register your product with NAFDAC, it could result in a number of serious consequences. These include