NAFDAC in Nigeria - Registration of Products.
Meaning of NAFDAC
NAFDAC is the national regulatory body in Nigeria concerned with the registration of food, medical devices, cosmetics, drugs, agrochemicals and other similar products in Nigeria. The full meaning of NAFDAC is National Agency for Food and Drug Administration and Control. In profile, it is similar to EFCC which is the Economic and Financial Crimes Commission
At the completion of the registration process, a NAFDAC Registration Certificate is given to the applicant indicating authorization to market the product in Nigeria while the product is assigned a NAFDAC Registration number which is unique.
Who is the NAFDAC Chairman?
The identity of the NAFDAC Chairman is one of the most frequent questions asked. The Chief Executive of NAFDAC is properly referred to as DG NAFDAC, currently Mrs Yetunde Oni. She is in an acting capacity as a substantive DG has not been appointed since the sac of the previous one.
What is NAFDAC Registration Number
This is an exclusive number given to a particular product by NAFDAC in Nigeria. This in actual fact confers the holder of the registration certificate with the right to market the product in Nigeria.
Also the Registration number on a product enables the users or consumers have confidence in the excellence and efficacy of the product.
The registration number is made up of a prefix and a suffix. The prefix refers to the class or type of product while the suffix is serially allocated.
What is the Validity of NAFDAC Registration in Nigeria
The normal registration certificate usually remains valid for a period of five years.
There are other types of authorizations which NAFDAC gives such as listing (duration 2 years) or Global Listing of supermarket items (duration 1 year).
Products are listed for different reasons such as when the data on the drug or other product is not enough for NAFDAC to authorize its sale for an extended period or sensitive products on which national drug surveys have not been conducted.
The Agency recently started an e reg service which will allow clients process part of the application online. It is still in beta phase, you can contact them on firstname.lastname@example.org or visit the e reg site which is dubbed NAPAMS
Overview of the Registration Process of NAFDAC
The Registration process is regarded as a burdensome procedure by all who have contact with NAFDAC.
The Agency claims a NAFDAC number can be gotten in 2 months but in truth it has been known to last up o one year.
The stumbling block is usually documentation. The best way to go about getting a NAFDAC number is to collect all the required documents beforehand and be proactive in asking questions.
Have you Registered a Product with NAFDAC in Nigeria? How long did it Take?
How to Register a Product with NAFDAC
Obtain the required documents including Power Of Attorney, Certificate of Business Incorporation in your country, Certificate of Manufacture and Free Sale or Certificate of Pharmaceutical Product ( whatever document that says you can sell the products freely in your country)
Other important documents are Comprehensive Certificate of Product Analysis, Certificate of Business Incorporation, Certificate of Registration of Brand Name/ Trademark, Completed Application Form, Application Letter for Import Permit.
Next, buy a form, submit the documents and pay the fees that would be given.
Nigerian Business Environment
The documents will be vetted and if satisfactory, you will be given an import permit authorizing you to import registration samples registration. The documentation vetting is done in stages - by regulatory and legal officers.
Submit the samples for vetting with a letter inviting the agency to visit the manufacturing facility and a copy of the permit given to import samples, certificates of analysis and receipts of fees paid.
The products undergo stringent analytical procedures at NAFDAC's laboratory. NAFDAC has over six fully equipped and functional with state of the art equipment, and they enjoy a lot of support from WHO nd other multilateral organisations. Although you will be informed that the analysis will take two weeks, it sometimes lingers on for months with no satisfactory response offered by the Agency. Very frustrating.
A series of meetings is conducts at different levels in NAFDAC where the history of the product including safety reports, documentations and test results are reviewed. Once the product scales through a NAFDAC number is assigned to it.
Is is necessary and advisable that you register your products with NAFDAC prior to selling as it is one of the few Nigerian institutions with bark and BITE.
NAFDAC recruitment occurs seldom, so the Agency is perpetually understaffed. It is advised you start early to complete the process on time.
Have more Questions about NAFDAC in Nigeria?
Ask me any other question you have about NAFDAC Registration in the comment section below.