PRODUCT REGISTRATION

REGISRATION INFORMATION

The National Agency for Food and Drug Administration and Control (NAFDAC) is empowered by law to regulate and control the manufacture, importation, exportation, advertisement, distribution and sale of regulated goods like cosmetics, drugs and food in Nigeria.

 

Okey IP’s services include full registration of products in both categories, as currently set out by NAFDAC: drugs and food.

  1.            Drugs include medical devices, vaccines, chemicals and pesticides, veterinary products, nutraceuticals and                ..........supplements, herbal preparations and cosmetics. Clinical trials of drugs are also regulated by NAFDAC.

  2.            Food products include processed and semi-processed food, bottled or sachet water, alcoholic and non-alcoholic .  ......... drinks, etc.

Requirements for procurement of samples:

During the registration process, NAFDAC will require samples of the product. NAFDAC therefore grants special authorization to import such samples if manufactured outside Nigeria.

  1.           Documents for clearing and taking delivery of samples must be submitted to NAFDAC

  2.           Certificate of Analysis issued by the manufacturer

  3.           Certificate of Manufacture and Free Sale issued by the appropriate regulatory authority in the country of origin

 

How long does the full registration procedure take?

 

Product registration can be divided into two stages and although the required documentation varies for different drug and food categories, the general procedure is similar.

  1.           Stage one: One month - applying and obtaining approval to import samples (not applicable if the product is locally ......... manufactured), for procurement and completion of the application for each product.

  2.           Stage two: Two months - Issuance of the NAFDAC registration number.

 To work within the time frame, all required documents must be submitted by the applicant.​

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