Nigeria - Renew License to Manufacture of Drugs for Sale

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Procedure

Apply In-Person:

1. To Renew License to Manufacture of Drugs for Sale in person, the applicant has to visit the office of Director General of National Agency for Food and Drug Administration and Control.
2. The contact link of NAFDAC can be found below contact link
3. Before visiting the office, the applicant needs to perform some pre-processes which are explained in further steps.
4. The applicant must prepare an application letter on the company letterhead addressed to the Director General requesting to get the concerned product registered.
5. Make sure that you have all the documents listed in the “Required Documents” section of this page.
6. Visit the NAFDAC office and submit the application package to the Liaison Office of the Director (LOD).
7. After documentation review, required GMP inspection and Product analysis in lab, products are sent for approval meetings. For products labels with compliance issues, compliant artworks may be submitted with a commitment letter from manufacturer.
8. For products approved at the meeting, ‘Notification of Registration’ is issued to the applicant while ‘Compliance Directive’ is issued to those not approved.
9. Once all the requirements are met, the applicant will be issued a renewed Certificate of Registration.

Apply online

1. Renewal of License to Manufacture of Drugs for Sale must be obtained from NAFDAC by applying online in the following NAFDAC Automated Product Administration Monitoring System register online
2. Click on the link and click on the “Register” button which will be present at the top in the homepage. Clicking that will automatically scroll down to the ‘Quick links’ section in which you can find ‘NAFDAC Client’ box.
3. Click the “Sign in” button below that and you will be directed to the login page. If you have an account already, enter the login details in the relevant fields and click “Login” button.
4. If not, click “ARE YOU NEW? REGISTER” link or click “Register” button present on the left side. Registration page will open.
5. Complete the ‘Company details’ section by entering the details in the respective fields provided and the ‘Company contact Information’ section with the contact of the concerned company.
6. In the ‘Applicant Information’ section, enter the names of the applying person and set a password for your account.
7. In the ‘Applicant Documentation’ section, one should upload the documents as required by clicking the “Choose file” button.
8. Once completed filling the application form with details required and uploading documents required, click “Save” button.
9. Successful company registration message will appear and an email with an account activation link will be sent to the email Id you provided.
10. Click on the activation link to activate your account. Your account is activated and you will be redirected to the login page.
11. Enter the login details and click “Login” button. In the homepage, you can find “Registration form” under ‘Navigation’ menu on the left side of the page.
12. Click on it and select ‘Application type’ as ‘New Product Registration’ and also select the category as applicable, Product source, Sub-category of products as applicable, then click “Continue” button.
13. Then, registration form for registering the product will appear. Complete the first tab with details about the concerned product and click “next” button.
14. Provide the name, contact and address details of the Manufacturer in the respective fields under the ‘Manufacturer Information’ tab and click “Next” button.
15. Clicking that will open the ‘Manufacturing Site Information’ tab, complete that with appropriate details, click “Add New Site” button and click “Next” button. You can also check the box present at the top if the Manufacturing Site Information is same as the Manufacturer Information.
16. In the next tab, use search box to search for the controlled substance if the product has controlled substances and add it by clicking “Add” button.
17. If not, check the box present in the tab and click “Ok” in the popup to proceed. Click “Next” button, fill the fields about the product that appear further and click “Next” button again.
18. Further, upload the scanned copies of the required documents by clicking the “Choose file” button and click “next” button.
19. You have to pay the necessary amount of fees for the registration in the next tab, click on “Make Payment” button, Remita Retrieval Reference will be opened in which you have to click “submit” button.
20. Then enter your card number, date of expiry and CVV in the respective fields and complete the payment by clicking “Pay” button. After completion of payment, an invoice will be generated which you have to produce during the application.
21. In the next page, the product/application summary will be displayed, click View application button and print the form for submission.
22. Finally click “Submit” button and the online registration form has been completed. Attach all the required documents with the registration form print-out and application letter.
23. Visit the NAFDAC office and submit the application package at the Liaison Office of the Director (LOD).
24. After documentation review, required GMP inspection and Product analysis in lab, products are sent for approval meetings. For products labels with compliance issues, compliant artworks may be submitted with a commitment letter from manufacturer.
25. For products approved at the meeting, ‘Notification of Registration’ is issued to the applicant while ‘Compliance Directive’ is issued to those not approved.
26. Once all the requirements are met, the applicant will be issued a renewed Certificate of Registration.

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Required Documents

• Application letter
• Proof of premises registration
• Previously issued license
• Certificate of Pharmaceutical Product
• Product Quality Review document
• Manufacturing License
• Certificate of Registration of Brand Name/Trademark
• Notarized Declaration
• Power of Attorney/Contract Manufacturing Agreement

For reference guidelines

Office Locations & Contacts

Pharmacists Council of Nigeria - Head Office,
Plot 7/9 Industrial Layout, Idu,
P.M.B. 415 Garki,
Abuja, Nigeria
Tel: +234 704 453 3099 / +234 806 605 5429
Tel: Tel: 08079792616
Email:[email protected]
Website :Link

Eligibility

• Any Drug manufacturing license holder, whose license expiration is just a month ahead, can apply.

Fees

Please refer fees details

Validity

The license is valid for a period of five years.

Documents to Use

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Sample Documents

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Processing Time

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Related Videos

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Instructions

• An application for renewal should be initiated not later than 30 calendar days to the date of expiration of the current/valid Licence.
• The application should be made on the company’s letter head which should contain the current/valid email address and telephone number of the applicant.
• The applicant should provide the details of the product(s) for renewal and clearly state the purpose in the body of the letter along with the contact details of the manufacturer of the product(s) (i.e. name, address email and telephone number of the contact person).
• Refer for more instructions guidelines

Required Information

• Company Name and Type
• Tax Identification Number
• Registration Certificate Number
• Incorporation Date
• Company physical and mailing address
• Contact number and email address
• Applicant names
• Source and category of the product
• Product Description and HS code
• Manufacturer name and address
• Particulars of the product
• Card details

Need for the Document

Every license to Manufacture of Drugs for Sale must be renewed once in every five years of its validation period.

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Other uses of the Document/Certificate

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e.g. Birth Certificate can be used as proof of identity.

External Links

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