The National Agency for Food and Drug Administration and Control is a body that is saddled with the regulation and granting of license for exporters, importers, manufacturers, and registration of products which includes; chemicals, cosmetics, drugs, consumable goods, medical and biological services produced in Nigeria and outside Nigeria but imported into Nigeria. Consumable goods and product registration are in categories, the include; locally manufactured and imported goods. NAFDAC Registration will give you the license to operate your business anywhere in Nigeria.
You will get Good Manufacturing Practice (GMP) certification which is a system that ensures products are consistently produced and controlled for quality and standard. It is structured to minimize the risks involved in any food, chemical, cosmetics and Pharmaceutical production that cannot be traced without testing. So, the Agency gives you registration number when your facility meet their standard requirement. Your facility will be accessed based on five major areas known as (components of GMP).
Requirements for NAFDAC Registration
1. Documentation
This is the first stage and it is very important to be explicit. This document will determine whether you will be registered or not. Whatever is in the document must be reflected on ground. Submit all documents for registration and application letter in accordance with the issued guideline on first appearance for any of the services to be rendered by NAFDAC.
Here are the documents to present:
- Letter of application,
- CAC paper (business name registration),
- Trademark registration,
- Company standard operation procedures,
- Packaging materials.
Representatives of NAFDAC will come to your factory in other to confirm or audit what you documented on your papers. That is why you have to make sure everything is accurate no honky punky. The agency believes that whatever is not in the documentation is not yet done.
2. Facility
NAFDAC will visit your building for inspection to access the layout, production flow, hygiene standard, construction bushes etc. Your documentation may be complete and perfect but if your facility is not according to their test or unprofessional you will be given critical compliance directive. Consult with experts on how the building should look like.
The building for approval should contain;
- Cloakroom: for changing outfit
- Raw material room: it acts as store for keeping raw and packaging materials
- Production room or action room: this is where production takes place
- Finished product room: this is a room where finished products are packed and arranged pending distribution
- Conveniences (where to ease oneself)
Others are:
- Water treatment facility
- Laboratory
- General storage room
Addition of any of these last three facility will depend on what you are producing. All the above facilities have specification which must be adhered to strictly
3. Equipment
The equipment to install will depend on what you are producing, it can be specifically made or adopted for the intended production. Equipment has to be standard and distinct for each use. Tables and surfaces that usually have contacts with drugs or food during production should be made of stainless steel. This is to prevent build-up of contaminants, cross contamination and to allow for effective cleaning.
Samples
Provide samples of the products to be registered when you receive notification from NAFDAC for laboratory.
NAFDAC Registration Fees
Ensure all payments are done at the appropriate time. In my next post, I will highlight NAFDAC fees.
Timeline or Duration for NAFDAC Registration
The duration of approval depends on the type of product you are rendering.
- Document verification is 10 days
- Facility inspection and sampling is 10 days too
- Laboratory analysis takes a longer time of 30 days for food while drug is 4o days.
- The final vetting is 10 days
- Finally, the approval, meeting and issuance of NAFDAC registration number which is the certificate of registration is 20 days
Registration of food product takes not more than 90 days. While drug registration is 120 days, variation of product registration takes not more than 60 days.
Compliance Directive
Applicants are required to compulsorily comply with Compliance Directive (CD) within 7 days of issuance. Failure to do so may result in cancellation of your application. And any delay will not be counted within the 90 days for registration.
Conclusion
it is criminality to distribute your products all over the country without getting the necessary certification from NAFDAC. The process of NAFDAC registration is cumbersome but you must have to go through it. if you are able to provide all that is required it will be less stressful for you. To obtain the certificate you must first register your business name with CAC.
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