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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Frequently Asked

  • Why must I file Annual Returns?

    It is a mandatory statutory requirement under the Companies and Allied Matters Act to file Annual Returns yearly. 

  • Do I need a Company Secretary?

    A limited liability company (LLC) must not have a company secretary.

  • What is an execution clause in a contract?

    This is the section in which the parties sign the contract or agreement.

  • What will happen if I buy the wrong category of forms with NAFDAC?

    Nothing, the purchased form will be in your account for future use.

     

  • What is data protection?

    Data protection is a legal process of protecting sensitive data.

  • What is eligible for Patent registration?

    Patents are granted for the invention of products or processes. However, for it to be patentable, the invention

    • Must be new,
    • Must have an inventive step that is not obvious to someone with knowledge and experience in the subject,
    • Must be capable of being made or used in some kind of industry and not be, a scientific or mathematical discovery, theory or method, a literary, dramatic, musical or artistic work, a way of performing a mental act, playing a game or doing business, the presentation of information, or some computer programs, an animal or plant variety, a method of medical treatment or diagnosis,
    • And must not be against public policy or morality.
  • Is there a penalty for late renewal of registration of products with NAFDAC?

    Yes, there is a late renewal fee, which is dependent on the category of the product.

  • How many directors do I need to start a company?

    A minimum number of one (1) adult director is required to form a company.

  • How long does a trademark registration in Nigeria Last?

    Trademark is valid for seven years from the date of application but you may renew the application for the trademark for an additional period of 14years.

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