Tuesday, January 4, 2011

NAFDAC REGISTRATION: STAGES INVOLVE TO REGISTER IMPORTED PRODUCTS

Stages involve to register products with NAFDAC in Nigeria is procedural. Every process needed to register any product must be followed to the later.First, know that NAFDAC categories registration of products basically into two parts; namely, imported products and locally manufactured products. Again, each part has classes under which products are registered such as Drugs, Foods, Cosmetics, Medical Devices, Herbal products, Narcotics, Pesticides, Packaged Water e.t.c.
Now, there five(5) stages each imported product must pass in order to license number:

Stage one: Documentation:
Here you are required to present the necessary documents specified by NAFDAC to register each products. These documents differ in some aspect depending on the class of product you want register. Some of the documents include Power of Attorney or contract manufacturing Agreement; Manufaturing license and free sale certificate, Trademark registration,certificate of incoporation/business name and many more.
Note: All the necessary documents must be found satisfactory before any other process can be carried out. 
Stage two: Import Permit:
If the documents complied with the NAFDAC requirements, permit to import samples of products is issued to the applicant. The applicant is requited to import specified samples to be used for vetting and Lab analysis.

Stages Three: Vetting of samples:
At this stage, samples of products presented are vetted. Such vetting includes checking the labels, leaflets, drugs information. There are minimum requirements for product labeling such as name of the medicine brand name, name and address of the manufacturer, production and expiry date, batch no, provision for NAFDAC NO and so on.
Documents to be submitted during the vetting are:
a. copies of import permit and receipt of payment
b. dossier according to NAFDAC format for drugs and pesticides
c. 3 samples for each product
d. Letter of invitation for inspection.
e.      Comphrensive Certificate of Analysis

Stage Four: Lab Analysis:
After the vetting is done, you are required to bring some samples for lab analysis. You’ve to submit specified quantities of sample products along with copies of receipt for the processing fee and application letter for the submission of samples. Then your product(s) goes to lab for analysis to ensure compliance with standard specification.

Stage Five: Meeting:
At this stage, if the product(s) successful meets the lab test, then the product will be presented at the meeting. Here, decisions are taken on whether the product qualifies to be given NAFDAC license Number or not. They usually seat two times over the product. If the product meets all the requirements, license number will be issued.

Stage Six: Collection of Notification Number:
Once the product is given license number, you will go ahead to collect the notification number. You’ve to pay the specified amount for the license certificate and present the receipt and your notification number will be given to you. You are now qualified to import the product for commercial purpose while you wait for the certificate to come out. It takes six months or so for your certificate to be ready. The certificate usually last for the period of five (5) years.

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