How to apply for COPPs (Certificate of Pharmaceutical Products)?

The certificate of a pharmaceutical products (COPPs) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. Read More: https://bit.ly/31cfTYl

1. How To Apply For Copps (Certificate
Of Pharmaceutical Products)?

2. WHAT IS COPPS?

3. Certificate Of Pharmaceutical ProductCopps
•COPP or Certificate ofPharmaceutical Productsis the WHO
recommended certificate. The format is made as per WHO guidelines, and
it has to be uniform across the world.
•Why is it considered so much important? Because it is mandatory to submit
it to the importing country when the product is intended for licensing
authorization or renewal of registration.
•It is recommended by WHO to facilitate the importing countries in
assessing the quality ofpharma products. Also, it is a prerequisite
of importation and registration.

4. The Process Of Application
•As per the requirement, the application for COPP has to be made to zonal
or sub-zonal officer. Once the authorities perform inspection and give
satisfactory clearance, they issue the certificate on behalf of Drug
Controller General India.
•The application has to be addressed to DDC or ADC of zonal or subzonal
officer. A covering letter and product summary should be submitted along
with the letter.

5. Cont..
•It has to be clearly mentioned that whether the application is for fresh
certification or reissue? The scrutiny process will happen accordingly. The
CDSCP officer reviews the application and accepts it if it is found ok.
•Along with the forwarding letter, you should submit the list of products,
product manufacturing license, product summary sheet, and site master file.

6. Cont..
•Submit the quality manuals along with specifications, master validation
plan, master formula records, and manufacturing layout with the
application.
•You need to give the list of people with their qualification, designation, and
experience. Infrastructure details such as a list of equipment, utilities, and
instruments are required.

7. PROCEDURE FOR ACCEPTING THE APPLICATION
•CDSCO officers check and scrutinize the application. They are supposed to
inspect as per WHO guidelines.
•The checklist is checked during the inspection. The report mentions
discrepancies if any.Zonal and sub-zonal authorities make a review report
and inspection report according to the guidelines.
•If rejected, then the firm has to reapply after compliance after 5 months.
Earlier compliance report has to be submitted with that.

8. •The blog gives a broad idea of the application process, various stages
involved in it, and the process of accepting an application.
•However, it is always better to check the official websites for relevant
information. Since the rules, norms, and procedures are subject to change,
it is always better to get updated information.
•If there is no error in applying, then there is a fair chance of getting
it through in one attempt.

9. Also Read :
•Ambit Bio Medixis a leading and one of thebest PCD Pharma Franchise
Company in India. It is dedicated to enhance the quality of healthcare
industry by providing best pharmaceutical products for distributorship and
franchise.
•How to Choose Product for New Pharmaceutical Company?
•How to get Wholesale Pharmaceutical Drug License?

10. CONTACT US
Mob No:-9825965521
E-Mail:[email protected]
Address:-Ambit House,TajpurRoad, Changodar,
Ahmedabad -382213 Gujarat-INDIA.
India Gujarat
Website:-
www.ambitbiomedix.com