CDSCO extends validity of WHO/GMP Certificates of Pharmaceutical Products

Certificate of Pharmaceutical Product (CoPP) is issued under the WHO GMP Certification Scheme for the purpose of international commerce, i.e., for registration of products in foreign countries. Earlier the validity of CoPP was extended from 2 years to 3 years vide Office Memorandum No. 7-5/2018/Misc/048 dated 08.05.2018.

The decision to give an extension came after the number of pharma companies pointed out the difficulties in renewing certifications in light of the COVID-19 pandemic and the consequent nationwide lockdown 

"This office has received representations from stakeholders requesting to extend the validity of WHO GMP Certificate/CoPP whose validities are expiring between now and August 2020 in view of COVID-19 outbreak," CDSCO in its notice stated 

"The matter has been examined in light of the current situation of COVID 19 outbreak and in order to maintain the continuity of essential activities by the pharmaceutical industry, it has been decided that validity of WHO GMP/CoPP expiring from March to August 2020 may be extended by 6 months from the date of expiry of the certificate as per WHO GMP Certification guidelines," CDSCO stated in its decision

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https://medicaldialogues.in/pdf_upload/pdf_upload-128109.pdf