India - Apply for Certificate of Pharmaceutical Product (COPP)

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Procedure

Apply Online

1. To Apply for Certificate of Pharmaceutical Product (COPP), the applicant has to make the application online via link
2. The applicant has to click the “Sign In/Up” button.
3. Without registering the applicant can be done through the OTP format.
4. Enter the mobile number and click the “Get OTP” button.
5. The applicant will receive the OTP from the entered mobile number.
6. Enter the OTP and click “Validate & Proceed”.
7. To log in with a username and password click the “Sign in with Username and Password”.
8. Enter the details with the captcha code and click “Validate & Proceed”.
9. The applicant has to select the application form from the menu list and click the “Submit” button.
10. Enter all the details in the application form and click the “Next” button.
11. And upload all the necessary documents that are mentioned in the “Required Documents” section of this page and click the “Proceed” button.
12. To review once, the applicant can view all the details in the application form and click the “Save & Proceed” button.
13. Pay the prescribed amount fee in online mode.
14. The applicant has to pay the prescribed fee as requested by the authority.
15. Once completed with all the details click the “Submit” button.
16. After receiving the application, the concerned authority will check the submitted application and document set. If all are in place, the application will be accepted.
17. Then the application will be processed further. All the updates on the application status will be sent via SMS to the applicant’s mobile number.
18. Once the process gets completed, the applicant gets a call from the office regarding the application.
19. Depending on the nature of the product, an inspection of the manufacturing facility may be conducted by the regulatory authority.
20. If the application is approved and all requirements are met, the CDSCO or the State Drug Regulatory Authority will issue the Certificate of Pharmaceutical Product (COPP).
21. The validity of the COPP is usually three years from the date of issue, but this may vary based on specific regulations.
22. This entire process can be completed within 30 days or as per the timeline advised by the respective department authority.

Apply In Person

1. To Apply for Certificate of Pharmaceutical Product (COPP), the applicant has to approach the State or Central Drugs Standard Control Organization link
2. An application form will be provided to the applicant by the concerned officer or it can be downloaded from the following link link
3. The applicant has to fill in all the necessary details in the application form. (Incomplete applications are not accepted)
4. Make sure that the applicant has attached all the necessary documents that are mentioned in the “Required Documents” section of this page.
5. The applicant has to attach photocopies of the required documents along with the application form while submitting it.
6. Submit all the documents with the completed form to the concerned officer.
7. The applicant has to pay the prescribed fee as requested by the authority.
8. After receiving the application, the concerned authority will check the submitted application and document set. If all are in place, the application will be accepted.
9. An acknowledgment receipt will be provided. Please save it for future reference.
10. Then the application will be processed further. All the updates on the application status will be sent via SMS to the applicant’s mobile number.
11. Once the process gets completed, the applicant gets a call from the office regarding the application.
12. Depending on the nature of the product, an inspection of the manufacturing facility may be conducted by the regulatory authority.
13. If the application is approved and all requirements are met, the CDSCO or the State Drug Regulatory Authority will issue the Certificate of Pharmaceutical Product (COPP).
14. The validity of the COPP is usually three years from the date of issue, but this may vary based on specific regulations.
15. This entire process can be completed within 30 days or as per the timeline advised by the respective department authority.

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Required Documents

• Application form link
• ID proof (birth certificate, PAN card, Aadhar card, etc)
• Address proof – (Driving license, passbook, utility bill, etc)
• Covering letter indicating the purpose of “COPP”.
• Copy of valid “WHO-GMP” certificate.
• Copies of master formula records maintained by firm - wherever required.
• Copies of the product approvals for applied drugs.
• Copies of manufacturing licence.
• List of products for which “COPP’s” are required.
• Copies of the product permission letters of the requested products for the issue of “COPP’s”.
• Formats of “COPP”
• Stability data (3 batches) accelerated / real time.
• Copy of the power of attorney/authorization letter.
• Master validation plan.
• Process validation for 3 batches of each product.
• Quality manuals.
• Specifications.
• List of standard operating procedures (SOP’s).
• Manufacturing layout.
• List of primary and secondary impurity and reference standards/cultures available with the firm.
• Recent organization charts.
• List of personnel along with their qualifications and training.
• Floor-plans.
• List of instrument(s)/equipment(s) including number of computers.
• Procedures being followed to maintain security and integrity of computerized data and records.
• Demand draft for the advised amount.
• Company PAN card.
• Aadhaar card of directors.
• Self-declaration.
• Self-addressed envelope with stamp.
• Fee receipt
• Any other documents (If required)

Office Locations & Contacts

Central Drugs Standard Control Organization
Ministry of Health and Family Welfare,
Directorate General of Health Services,
Government of India FDA Bhavan,
ITO, Kotla Road, New Delhi -110002
Contact – 91-1123216367
Email: [email protected]
Contact link: link
Contact link – link
Regional Office – link

Eligibility

• Any manufacturer of pharmaceutical products who intends to Apply for Certificate of Pharmaceutical Product (COPP) is eligible to make this application.

Fees

• The applicant has to pay the prescribed fee as requested by the authority.

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

• Application form link

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• This entire process can be completed within 30 days or as per the timeline advised by the respective department authority.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
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.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicants must complete the application form before submitting it. Incomplete applications will not be accepted.
• Applicants must provide genuine information while applying for this procedure.

Required Information

• Name
• Address
• PIN code
• State
• Country
• Age
• Education details
• Site plan
• Quality control details
• Contact number
• Email
• Fax
• Declaration
• Date
• Signature

Need for the Document

• In India, the Certificate of Pharmaceutical Product (COPP) is an official document issued by the Central Drugs Standard Control Organization (CDSCO) or the respective State Drug Regulatory Authority to certify the status of a pharmaceutical product. The COPP is primarily used for the export of pharmaceutical products from India to other countries.

Information which might help

• For more details link

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

link

Others

• The COPP serves as a declaration by the regulatory authority that the pharmaceutical product in question has been approved for marketing and sale in India and is of the same quality and standard as that of the approved product in the country of origin.