How to Get Herbal Product License in Nigeria

How to Get Herbal Product License in Nigeria By Yourself

  • The applicant must visit the Office of the Director General of NAFDAC (National Agency for Food and Drug Administration and Control), Registration and Regulatory Affairs Department to apply for a Herbal Product License.
  • You can find the address and contact information of the office in the contact link.

  • The applicant must complete some pre-processing before visiting the office. These steps are described in more detail.
  • To request registration of the Herbal product concerned, the applicant must submit a letter on company letterhead to the Director General.
  • You should ensure that you have all of the documents in the “Required documents” section.
  • Submit the application package to the Liaison Office of the Director at NAFDAC (LOD) by visiting the NAFDAC Office
  • Products are submitted for approval after documentation review, GMP inspection, and product analysis in laboratory. Compliant artworks can be submitted along with a manufacturer commitment letter for products labels that have compliance issues.
  • For products that were approved by the meeting, Notifications of Registration are issued to the applicants. Compliance Directives are issued to those who have not been approved.
  • After all requirements have been met, the applicant will receive a Certificate of registration.

Apply Online

  • NAFDAC must issue a Herbal Product License. You can apply online through the NAFDAC Automated Product Administration Monitor System: Register online
  • Click on the link, and then click on “Register”, which will appear at the top of the homepage. Clicking on that will take you to the “Quick Links” section, where you’ll find the “NAFDAC Client” box.
  • You will be taken to the login page if you click the “Sign In” button. Login to an existing account by entering the details and clicking the “Login” button.
  • Click “ARE YOU NEW?” Click the “Register” button on the left or the REGISTER link. The registration page will open.
  • Completion of the “Company Details” section. Enter the information in the appropriate fields and complete the section with the company contact information.
  • Enter the name of the applicant and create a password in the section ‘Applicant information’.
  • You can upload documents to the “Applicant Documentation” section by clicking on the “Choose File” button.
  • After filling out the application form, uploading any documents and providing details, click the “Save” button.
  • A successful company registration message will be displayed and an email with a link to activate your account will be sent using the email ID you have provided.
  • To activate your account, click on the activation button. You will be redirected back to the login page after your account has been activated.
  • Enter your login details and click the “Login” button. You will find the registration form under the navigation menu on the left-hand side of the homepage.
  • Click on it, select “Application type” as “New Product Registration”, and then click the “Continue” button.
  • Next, you will see the registration form to register the product. Click “Next” to continue.
  • Enter the Manufacturer’s name, contact information and address details in the fields below the “Manufacturer Information” tab and then click the “Next” button.
  • This will open the “Manufacturing Site Information” tab. Fill it out with all relevant details. Click “Add New Site” button, then click “Next”. If the Manufacturing Site Information matches the Manufacturer Information, you can check the box at the top.
  • Next, click “Add” to add the controlled substance.
  • To proceed, make sure to check the box in the tab. Fill in the remaining fields and click “Next”.
  • You can also upload the scanned copies by clicking “Choose File” and then click “Next”.
  • The registration fee must be paid in the next tab. Click on the “Make Payment” button. Remita Retrieval Reference opens. You will then need to click the “submit” button.
  • Enter your card number, expiry date and CVV into the appropriate fields. Click “Pay” to complete the payment. An invoice will be generated after payment is made. This invoice must be presented during your application.
  • The product/application summary is displayed on the next page. Click View application button to print the form.
  • Once you have completed the online registration, click “Submit”. All required documents should be attached to the application letter and printout of the registration form.
  • Submit the application package to the Liaison Office of the Director at NAFDAC (LOD) by visiting the NAFDAC Office
  • Products are submitted for approval after documentation review, GMP inspection, and product analysis in laboratory. Compliant artworks can be submitted along with a manufacturer commitment letter for products labels that have compliance issues.
  • Notification of registration is given to applicants for products that were approved at the meeting. Compliance Directive is issued to non-approved products.
  • After all requirements have been met, the applicant will receive a Certificate of registration.

Documents Required For Get Herbal Product

  • Application Letter
  • Take a printout of the completed registration form
  • Certificate of incorporation
  • Do you have evidence of trademark registration?
  • You must provide proof of payment
  • Contract Manufacturing Agreement
  • Trademark Registry proof of brand name registration
  • Ethnobotanical and any other document/report that is scientific in nature
  • You must show proof of membership in the National Association of Nigerian Traditional Medicines practitioners
  • The state Traditional Medicines Board/Pharmacist Council of Nigeria issues an annual license
  • Successful inspection report/Good Manufacturing Practices (GMP) certificate
  • Artwork/product labels
  • Comprehensive Certificate of Analysis
NOTE: You must submit all required documents in two sets.

Find Office Locations and Contacts

National Agency for Food and Drug Administration and Control. Registration and Regulatory Affairs Directorate.
Ground Floor, NAFDAC Office Complex,
Isolo Industrial Estate,
Apapa-Oshodi Expressway,
Isolo, Lagos
Phone no. : +234-1-4772452
E-mail: registration@nafdac.gov.ng
Homepage NAFDAC Website
Contact link

What are all the Eligibility

  • Any Nigerian organization that needs a license to manufacture, import or export, advertise, sell and distribute its Herbal Products, can apply.
  • An Incorporation Certificate must be obtained by the company applying.

Fees

For more information on fees, please contact the office.

Validity

The Certificate’s validity is dependent on the product and can be valid for between 2-5 years.

Processing Time

From acceptance of submissions to issuance or Registration number, the time frame for product registration is one hundred twenty (120) days.

Instructions

  • All submissions must be sent to the Office of Director. Contact details and address can be found under the “Office Locations” section.
  • Please note that you must submit all required documents in two sets.
  • The certificate of analysis must appear on the letterhead paper of the Quality Control Laboratory, where the sample was tested/evaluated. It should include the following information:
    • The product’s brand name
    • The batch number for the product
    • The expiry and manufacturing dates
    • Name, designation and signature
    • The content of active ingredients (Phytochemical assay).
    • Physicochemical analysis (including heavy metals tests)
    • Assays in microbiology
    • Safety and toxicology evaluation

Requirements Information

  • Name of the company and type
  • Tax Identification Number
  • Register Certificate Number
  • Date of incorporation
  • Physical and postal addresses of the company
  • Email address and contact number
  • Applicant names
  • Source and type of product
  • Product Description and HS Code
  • Name and address of the manufacturer
  • Specifications of the product
  • Card details

You will need the document

Without registering it in accordance to the NAFDAC Act, no product may be manufactured, exported, advertised or sold in Nigeria.

Information that might be of assistance

  • Labelling must be accurate, informative, and consistent with Agency Regulations.
  • Failure to meet these requirements could result in disqualification of your application or in a significant delay in registration processing.
  • An Advertising Permit is not granted automatically upon registration of a product. If the product is to go on the market, it will require a separate application and approval from the Agency. Simultaneous submissions of advertisement and registration applications are allowed.

The Application will be closed automatically if NAFDAC does not respond to any queries or inquiries within 90 days.

External Links

Source

Like

LEAVE A REPLY

Please enter your comment!
Please enter your name here