Nigeria - Obtain License or Permit to Import Orphaned Drugs

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Procedure

Apply In-Person:

1. To apply for obtaining license or permit to import Orphaned Drugs in person, the applicant has to make an application at the Registration & Regulatory Directorate of the National Agency for Food and Drug Administration and Control.
2. The applicant will have to prepare an application letter as a request for the License or Permit to ImportOrphaned Drugs, addressed to the Director-General of National Agency for Food and Drug Administration and Control.
3. Make sure that you have all the documents listed in the “Required documents” section of this page.
4. Attach all the required documents with the application letter, and then submit it at the NAFDAC Office in Lagos or any nearest NAFDAC office.
5. The contact link of NAFDAC can be found below: contact link
6. Address details of regional offices can be found in the following link: regional offices addresses
7. After submission, the application and accompanying documents are subsequently reviewed and verified.
8. If the application and attached documents are found sufficient, an Import Permit will be issued to the applicant.
9. Further, the drugs are put into vetting on successful completion of which, laboratory samples are given by the applicant along with the proof of payment, Certificate of Analysis and Proof of Submission for vetting.
10. Drugs which have got through successful review and satisfactory laboratory analysis, are further exhibited at the Approval Meetings.
11. In case if the drugs are approved at the meetings, the applicant will be issued a Notification of Registration or Listing.
12. For applicants whose drugs are disapproved, compliance directives will be issued.
    

Apply Online

1. To apply for obtaining License or Permit to Import Orphaned Drugs online, the applicant must visit the following link: e-license application link
2. If you have registered with the Nigeria Single Window Trade Portal, you can enter the user credentials in the fields provided and click “Login” button.
3. Otherwise, the person who wants to obtain a registration must contact/visit the Federal Inland Revenue Services office where he/she obtained the TIN and provide one valid email and mobile number, together with other company's identification details as per FIRS requirement.
4. After that, he/she can visit the following link and make the registration: apply online.
5. You will have to just enter TIN number, Email ID, text image in the respective fields and click “Validate” button.
6. Follow the instructions and complete the registration, then the applicant must be proceeding to apply for and obtain the certificate of analysis.
7. Visit the following link e-license application link and enter the user details in the respective fields, then click “Login” button.
8. NAFDAC e-License main page will be displayed. Default page is for new permits.
9. Proceed to complete the application form by providing required details under respective sections.
10. Start completing the tabs one-by-one by entering the required details and making the appropriate selections by following the on-screen instructions.
11. Follow the onscreen instructions and upload the necessary attachments as required in the application.
12. After completing, click an applicable button to submit the application. An email notification is immediately sent to your registered email address.
13. On submission, the application and other documents will be forwarded for examination and verification processes.
14. In the portal, you can find a tab named Support information tab provides a general status of application and Application Progress Indicator shows the current status of your application at NAFDAC.
15. Where there is a query on an application, an email notification is immediately sent to your registered email address.
16. Respond to queries raised, by using the ‘search’ function and ‘Support information’ tab. Make the appropriate changes by following the on-screen instructions and update the application.
17. Onceall the information is found sufficient, the application will be approved and the officials will proceed to take required steps to issue the certificate.
18. When the document is ready to be downloaded, a “print view” button will appear in the portal on the top of your application. Click that to download your certificate.
    

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Required Documents

• Application letter/ Online registration form
• Notarized Declaration
• Power of Attorney or Contact Manufacturing Agreement
• Certificate of incorporation
• Manufacture and Free Sale Certificate
• Proof of Manufacturer Registration
• Proof of drug registration
• Registration proof of brand names with Nigerian Trademark Registry
• Superintendent Pharmacist’s valid Annual license
• Premises Retention License
• Certificate of Analysis
• Product label or artwork
• Letter of Invitation for Inspection of the Manufacturing premises abroad
• Proof of payment
• Proof of submission for vetting
• Letter of commitment
  

Office Locations & Contacts

National Agency for Food and Drugs Administration and Control - Head Office
Address: Plot 2032, Olusegun, Obasanjo Way, br> Zone 7, Wuse, Abuja,
Nigeria.
Tel: 0700-1-NAFDAC (0700-1-623322), +234(0)-1-4609750
Tel: 0800-1-NAFDAC (0800-1-623322) +234(0)909-763-0506, +234(0)909-763-0507
Email: [email protected]

Website: Link
NAFDAC Regional Contacts:Link

Eligibility

• Any registered importer in Nigeria, who wishes to import Orphaned Drugs, can apply.
• The applying company must have a valid proof or registration.
• Each product to be imported must have registered with the NAFDAC.
  

Fees

Please contact the office for fees details.

Validity

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e.g. Birth Certificate Valid Forever

Documents to Use

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Sample Documents

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Processing Time

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Related Videos

Videos explaining the procedure or to fill the applications.
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Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• After submission, applications that has compliance issues with labels of their drugs, compliance artworks should be submitted by the manufacturer along with a letter of commitment which should state that the drugs will comply with standards further.
• Applicants are advised to complete the application form neatly and completely with absolute legibility and appropriateness to avoid rejections. Also, all the required documents must be furnished completely.
  

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

Companies intending to import Orphaned Drugs must possess a relevant Import Permit obtained from the National Agency for Food and Drug Administration and Control.

Information which might help

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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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Others

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