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FREQUENTLY ASKED QUESTIONS ON NAFDAC REGISTRATION IN NIGERIA
The National Agency for Food and Drug Administration and Control (NAFDAC) has made it easier for businesses in Nigeria to register their products with the agency. This is as a result of the automated product administration and monitoring system (NAPAMS) created by the agency. Product registration with NAFDAC usually brings up different questions and requests. In this article we try to provide answers to Frequently asked questions (FAQ) on NAFDAC Registration in Nigeria.
Q: Why do I need to register with NAFDAC?
A: NAFDAC is the body responsible for regulation and control of the manufacture, production, importation, exportation, distribution, advertisement, sale and use of certain products in Nigeria. As long as you intend to put up these products for the consumption of the general public, you must register with NAFDAC.
Q: What are the products that can be registered with NAFDAC?
A: There are three broad categories of products that can be registered with NAFDAC namely; food, cosmetics and drugs. It is mandatory to register any packaged product that falls under any of these categories.
Q: I want to register my product with NAFDAC. Where do I start and how do I go about it?
A: In order to register a product with NAFDAC, you must first critically examine the guidelines applicable to the product and fulfill all requirements and conditions attached. Afterwards, you may go online to:
Process for NAFDAC Registration is detailed below;
- You prepare and submit your application form together with all supporting documents.
- You make payment as assessed.
- The documents are verified and a date for inspection of facility is fixed.
- The inspection of the facility/ sampling of products is done, followed by laboratory analysis of the product.
- Final vetting and approval meeting follow.
- Then the NAFDAC Registration Number and certificate of registration is issued.
Q: What are the supporting documents I need to submit?
A: The documents for NAFDAC Registration include:
- Company Registration Documents
- Product Label
- Fumigation Certificate
- Food Handler’s certificate / Medical Fitness Certificate for Production staff, this should include the following: Sputum test, stool test, Urinary test, Widal test, Hepatitis B test.
- Batch Formulation.
- Site use Agreement (Where applicable)
- One vetting Sample and three labels
- Copy of Receipt of Payment for production registration
- SOPs for production, distribution /Recall, Quality assurance, Cleaning of equipment, receiving of packaging materials, Personal Hygiene, Water analysis (where applicable) and for cleaning of the environment (for small-scale enterprises)
- List of raw material and their source(s)
- Certificate of analysis of raw materials (optional for micro scale)
- Certificate of analysis of finished products (optional for micro scale)
- A signed and endorsed certificate of Pharmaceutical Product (for drug products)
- Original copy of the Power of Attorney from the product manufacturer (if imported).
- Letter of invitation from manufacturer to inspect factory abroad, full names and site of plant (where applicable)
- Permit to import samples (for imported products)
- Certificate of Free Sale (for imported products)
Q: What are the things I need to put in place before approaching NAFDAC to register my product?
A: The following include the necessary steps to take before approaching NAFDAC for registration of a product:
- Ensure that your business has been duly registered with Corporate Affairs Commission (CAC)
- Ensure that you have your trademark registration (but this is optional for micro-scale enterprises)
- Design and prepare your product label/packaging material according to the relevant regulations.
- Ensure that your personnel have and meet the NAFDAC requirements with respect to education, experience, good sanitation and hygiene habits as well as medical tests.
- Ensure that your building or facility and equipment meet the required standards.
- Ensure that all raw or packaging materials are of good quality and standard.
Q: How long does it take to get NAFDAC number?
A: The timeline is usually within ninety (90) working days for food products and 120 working days for drug products but may exceed this stipulated time.
Q: Do I need to register the products I’m importing as well?
A: Yes. In order to register the product, you must first get approval from NAFDAC to import into Nigeria. You must also be armed with the necessary documents to register the imported products.
Q: My business is small and still growing, do I need to register what I’m producing with NAFDAC?
A: As long as you are selling packaged products that fall into Food, Cosmetics and Drugs categories YOU HAVE TO REGISTER. NAFDAC categorizes enterprises into micro-scale, small-scale and large-scale enterprises depending on the size of your venture.
Q: What is a micro-scale enterprise?
A: This is an enterprise with not more than five (5) employees. It must have a facility or building that is purpose-built or adapted with minimum of a designated standard room that is not open directly to any source of contamination. However, there are products that cannot be registered under this scope. These include Meat and meat products (except dried), poultry and poultry products, fish and fish products (except dried), Milk & dairy products, packaged cooked rice, beans or fresh vegetables, baked potatoes, Beverages, Packaged water.
Q: What is a small-scale enterprise?
A: This is an enterprise with 1 to 10 employees. Its building can be purpose built or adapted. It must also have adequate space, capacity and equipment for its intended product (s) for registration.
Q: How do I know if a product has been registered with NAFDAC?
A: You can do a quick search on the NAFDAC registration portal at nafdac.gov.ng/our-services/registered-products/
Q: Will I need to renew my certificate after it’s been issued?
A: Yes, the certificate has to be renewed after 5 years
Q: Can a Foreign company or manufacturer register his product with NAFDAC?
A: A foreign company or manufacturer can only register his products through a Nigerian applicant or agent duly authorized by the foreigner to act on his behalf.