Certificate of pharmaceutical productCoPP.pptx

Certificate of pharmaceutical productCoPP.pptx

• 1.
  PES MODERN COLLEGE OFPHARMACY (Ladies) MOSHI, PUNE Savitribai Phule Pune University B.PHARM Semester- VII By Mrs. Sneha Patil Assistant Professor Dept. of Pharmaceutics Certificate of Pharmaceutical product (CoPP)
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  Certificate of Pharmaceuticalproduct (CoPP)  The certificate of pharmaceutical product (abbreviated: CPP) 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  It is often mentioned in conjunction with the electronic Common Technical Document (eCTD)  A CPP is issued for a single product, because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary  The CPP is mentioned in World Trade Organization documents, although the tightly regulated products are subject to bilateral trade agreements or regional trade agreements The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has instituted standards for this purpose but it is unclear how the ex-ICH countries operate their health regulators
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  Certificate of Pharmaceuticalproduct continue……… Scope  The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorisation) or renewal (prolongation) of registration, with the scope of commercialisation or distribution in that country  Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as prerequisite of registration or importation  In the presence of such CPP, WHO recommends to national authorities to ensure that analytical methods can be confirmed by the national laboratory, to review and if necessary to adapt product information as per local labelling requirements, and to assess bioequivalence and stability data if necessary
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  Certificate of Pharmaceuticalproduct continue……… Need  CoPP is needed for obtaining global marketing approval for any FPP intended for animal or human use  This certificate is issued by Competent authority (CA)of the exporting country and is intended for use by the CA within an importing country  It is issued for the following purposes: 1. A Product is under consideration for product license/ marketing authorization that will authorize its import and sale in the importing country 2. Administrative action is required to renew, extend or review such license  This certificate is issued for every medicinal product, which includes information – trade name, pharmaceutical dosage form, strength and name of country to export
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  Certificate of Pharmaceuticalproduct continue……… Need  CoPP is issued to: 1. Marketing authorization holder (MAH) for medicinal with valid marketing authorization or their representatives 2. Manufactures without valid marketing authorization and with valid marketing authorization 3. Wholesale distributor authorized by the MAH to consult the information for the medicinal product
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  Certificate of Pharmaceuticalproduct continue……… Type 1. WHO 1975 version 2. WHO 1988 version 3. WHO 1992 version 4. USFDA version
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  Certificate of Pharmaceuticalproduct continue……… Process Fig. 1 Process of CoPP application
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  Certificate of Pharmaceuticalproduct continue……… Content and format  The content of CPP consists of the following main data: a. Exporting (certifying) country b. Importing (requesting) country c. Name, dosage (pharmaceutical) form and composition of the product(active ingredient and amount per unit dose d. Information on registration (licensing) and marketing (presence on the market) status of the product in the exporting country e. Number of product license (including license holder details, license holder’s involvement in manufacturing if any) and date of issue, if applicable f. Appended summary of technical basis on which the product has been licensed (if required by the issuing authority) g. Appended current product information h. Details on the applicant for the CPP i. If marketing authorisation is lacking in the exporting country, information about reasons
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  Certificate of Pharmaceuticalproduct continue……… Content and format  When applicable, information if the manufacturing site is periodically inspected by certifying authority and if the manufacturing site complies with Good Manufacturing Practice (GMP) as recommended by WHO  Although issuing authorities claim that their CPP conform to WHO format (a statement to confirm whether or not the document is issued in the format recommended by WHO should be included in the certificate), their format and content may vary from an issuing country to another  Also, some authorities do not issue CPP if the respective drug is not licensed in the exporting country (e.g. Italy)  In this last case, a Certificate of Exportation is issued instead, with a format and content similar to those of CPP
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  Certificate of Pharmaceuticalproduct continue……… Importance  To assess quality, safety and efficacy of the product as they approve for marketing  A CoPP RA in the exporting demonstrates country and product follows correct guidelines and procedures of GMP