How to register drugs manufactured in Nigeria with NAFDAC

How to register drugs manufactured in Nigeria with NAFDAC

July 23, 2019

NAFDAC is the agency responsible for the control and regulation of consumable products in the country. Some of the products they regulate include: food, drugs, cosmetics, medical devices and packaged water including all drinks, animal feed and veterinary products, etc.

Follow the following steps to register your drug or veterinary product

1.Purchase Product Registration Form online http://registration.nafdac.gov.ng/ and submit duly completed form at LOD (R&R) at the agency’s office , along with the following documents;

  • Application letter for product registration
  • Evidence of satisfactory production inspection issued by NAFDAC
  • Three vetting samples
  • Photocopy of certificate of incorporation issued by the corporate affairs commission (CAC)
  • Certificate of analysis for finished Product.
  • Contract manufacturing agreement (where applicable)
  • Photocopies of receipts of payment for pre-registration inspection (N20,000) and laboratory analysis (N30,000)
  • Current annual license to practice of the Superintendent Pharmacist OR Veterinary License
  • Current Certificate of Registration / Retention of Pharmaceutical Premises or Veterinary Premises
  • Evidence of Trademark approval from Federal Ministry of Commerce

NAFDAC Registration could be an herculean task and a Compliance Directive is given where an applicant does not meet all the requirements for registration e.g incomplete documents, failure to meet conditions for inspection , etc. Applicant is mandated to comply with Compliance Directive (CD) within 7 days of issuance.

Note: failure to comply with any CD issued by NAFDAC may be a basis for cancellation of the application and all delays of the client will not be counted within the registration timeframe.

Best regards,

Team 618 Bees

 

The information in this blog post (“post”) is provided for general informational purposes only, no information contained in this post should be construed as legal advise, nor is it intended to be a substitute for legal counsel on any subject matter. No reader of this post should act or refrain from acting on the basis of any information included in, or accessible through this post without seeking the appropriate legal or professional advise from the particular facts and circumstances at issue from a lawyer.

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