Going into food and drug manufacturing is a good venture but one need to be aquatinted with the steps involved in setting it up in terms of getting registered with CAC and getting NAFDAC registration. An entrepreneur in Nigeria, who intends to scale up and sell goods which falls under the registrable products of NAFDAC, must as a matter of urgency begin the process
What is NAFDAC? it is an acronym for National Agency for Food and Drugs Administration and Control. Nafdac is the federal government agency in Nigeria, the role of Nafdac is to regulate food, drugs, water and consumable products in Nigeria. NAFDAC Act Cap N1 LFN empowers the Agency to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics and among other regulated products.
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The registration process with the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria can be complex and involves several steps. Here is a general overview of the registration process:
Product Classification: Determine the appropriate classification for your product based on NAFDAC’s guidelines. NAFDAC regulates various products, including food, drugs, cosmetics, medical devices, and chemicals.
Product Report Preparation: Compile a comprehensive report containing all the necessary documentation required for product registration. This typically includes product information, formulation, manufacturing process, labeling details, stability studies, safety data, and any other relevant scientific data.
Appointment of an Authorized Regulatory Consultant (ARC): Engage the services of an Authorized Regulatory Consultant (ARC) who is registered with NAFDAC. The ARC will guide you through the registration process and assist with report preparation and submission.
Pre-registration Meeting: Request a pre-registration meeting with NAFDAC to discuss the registration requirements, submission process, and any specific concerns or questions related to your product.
Application Submission: Submit the completed product report along with the prescribed registration application form to the NAFDAC office in the state where you wish to carryon business. Ensure that all required documents are properly organized, signed, and notarized where necessary. Notary comes in where the product is manufactured abroad.
Document Verification: NAFDAC will review the submitted documents for completeness, accuracy, and compliance with the applicable regulations. They may request additional information or clarification during this stage.
Laboratory Analysis: NAFDAC may conduct laboratory analysis of the product samples provided as part of the registration process. This is to verify compliance with quality, safety, and labeling standards.
Inspection: NAFDAC may carry out an inspection of the manufacturing facility to assess compliance with Good Manufacturing Practice (GMP) guidelines and ensure that adequate quality control measures are in place.
Evaluation and Approval: Once NAFDAC has reviewed the documentation, conducted necessary analysis, and completed the inspection (if applicable), they will evaluate the application and make a decision on the registration. If approved, you will receive a Certificate of Registration.
Post-Approval Compliance: After obtaining the Certificate of Registration, it is important to comply with NAFDAC’s post-approval requirements, such as adhering to labelling regulations, post-marketing surveillance, adverse event reporting, and any other obligations specific to your product category.
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You can actually carry this process out all by yourself but it is advisable to engage the services of a consultant with knowledge of how the system works and NAFDAC requirements. This will enable the process to be seamless and fast too.
How To Process Nafdac Registration for Your Products.
Processing a NAFDAC registration for your products if they fall within consumable products requires preparation.
- like I said earlier, you have to follow the steps and one of the steps is to register your company with corporate affairs commission.
- Visit Any Nafdac Branch office in your State. If you are residing in Port Harcourt Rivers State their office is located at Federal secretariate opposite Military Hospital
- Obtain a form and fill the form carefully.
- Alternatively visit Nafdac online portal
To aid your application, you need to find out if your product falls within small scale, macro scale.
The following cosmetics products are allowed under Micro and small scheme, Petroleum Jelly, Shea Butter, Hair Cream (Oil based), Oils e.g. Coconut oil, Laundry detergents, Starch, Liquid Air Freshener, Soaps
How to Register Micro scale facility with Nafdac – Accordingly A micro scale facility is a business enterprise with not more than five (5) employees
To register a micro scale facility, follow these steps
- Provide Evidence of Registration with Cooperate Affairs Commission (CAC) (Business Name and/ or incorporation)
- Site use Agreement (Where applicable)
- Evidence of Trademark approval to protect the product brand /or business name.
- One vetting Sample and three labels
- Fumigation certificate
- Food handlers certificate / medical fitness certificate for production staff, this should include the following: Sputum test, stool test, Urinary test, Widal test, Hepatitis B
However, a small-scale facility is a facility 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. The process for its registration is as stated above.
If you need more clarification on this you can visit Nafdac office in your state or contact us on :
