Nigeria - Get Certificate of Pharmaceutical Product (COPP)

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Procedure

Apply In-Person:

1. To apply for a Certificate of Pharmaceutical Product (COPP) in person, the applicant has to visit the office of the National Agency for Food and Drug Administration and Control.
2. The contact link of NAFDAC can be found in the following contact link
3. Visit the office and obtain an application form for Certificate of Pharmaceutical Product (COPP) with respect to the requirement from the relevant department.
4. Complete the form with appropriate information under relevant sections. Attest it with your signature once completed.
5. Once completed filling the application form, make sure that you attached all the documents listed in the “Required documents” section of this page.
6. Then, submit it in person to the relevant authority at the office. Make the stipulated payment as directed by the officials.
7. After submission, the application and other documents will be forwarded for examination and verification processes.
8. Once the verification and validation processes are over, the application will be approved and the officials will proceed to take required steps to issue the certificate.
9. When the document is ready to be collected, the applicant will receive a notification from the office through email or phone call regarding the collection and the applicant can collect it by any applicable means.
10. Meanwhile, the applicant can also contact the office regarding the application status.
    

Apply Online

1. To apply for a Certificate of Pharmaceutical Product (COPP) online, the applicant must visit the following 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 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. For digitization of certificates/permits, please click ‘Permit/Certificate Enrolment’ option on the left side.
9. Start completing the tabs one-by-one by entering the required details and making the appropriate selections by following the on-screen instructions.
10. After successfully completing all the tabs, click “Submit” button to submit the application form. Click “Yes” button in the dialogue that appears.
11. Click “ok” button in the next tab. An email notification is immediately sent to your registered email address.
12. On submission, the application and other documents will be forwarded for examination and verification processes.
13. 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.
14. Where there is a query on an application, an email notification is immediately sent to your registered email address.
15. 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.
16. Onceall the information is found sufficient, the application will be approved and the officials will proceed to take required steps to issue the certificate.
17. When the Certificate 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

• Completed application form
• Proof of company registration
• Applicant Identification proof
• Tax Identification Number
• Relevant Inspection/Quality Analysis report
• Proof of Power of Attorney (for companies outside Nigeria)
• Proof of payment (if any)
• Any supporting document (as instructed)
  

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 Pharmaceutical Product Manufacturer, who needs a certificate based on the product’s quality, can apply for a COPP.
• In case of manufacturers outside Nigeria, the application can be made with the help of power of Attorney signed by the manufacturer.
  

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

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Instructions

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e.g. The state office holds birth records since january 1908.

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

• Certificate of Pharmaceutical Product may be required by the Manufacturer of a pharmaceutical product when its drugs are required to be registered with the NAFDAC before import.
• It is certification recommended by the World Health Organization for authentication quality of a pharmaceutical product.
  

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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