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


Presentation Description

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:


Presentation Transcript

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How To Apply For Copps Certificate Of Pharmaceutical Products

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Certificate Of Pharmaceutical Product Copps • COPP or Certificate of Pharmaceutical Products is 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 of pharma products. Also it is a prerequisite of importation and registration.

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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.

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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.

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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.

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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.

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• 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.

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Also Read : • Ambit Bio Medix is a leading and one of the best 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

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