Health Canada Publishes Guidance Document on the Application for a Certificate of a Pharmaceutical Product (CPP)

Health Canada Guidance: Application for a Certificate of a Pharmaceutical ProductA Certificate of a Pharmaceutical Product (CPP) is a certificate used by the Health Products and Food Branch Inspectorate (HPFB Inspectorate) “establishing the status of pharmaceutical, biological, radiopharmaceutical or veterinary product listed and the GMP status of the fabricator of the product.” CPPs replace the formerly used Certificates of Free Sale which “were used to attest that the pharmaceutical products were fabricated in compliance with GMPs.”

A CPP is issued to applicants whom are DIN owners (or, in the case of radiopharmaceuticals the party to which an NOC has been issued), the fabricator of a pharmaceutical product (if it is located in Canada and GMP compliant), or, a third party (with written authorization for the issuance of the CPP from the DIN owner). The latter case must be updated annually.

There are certain requirements the applicant must meet in order to receive a CPP. “When the pharmaceutical product is fabricated and packaged/labelled in Canada, a CPP is issued if all of the following requirements are met:

  • the fabricator and packager/labeller are GMP compliant;
  • the pharmaceutical product has a valid DIN and a valid date of notification;
  • OR in the case of radiopharmaceuticals an NOC has been issued and the product has a valid date of notification
  • the pharmaceutical product is sold on the Canadian market;
  • the applicant must be located in Canada”

“When the product is fabricated in a foreign country and packaged/labelled in Canada or fabricated in Canada and packaged/labelled in a foreign country, a CPP is issued if all the following requirements are met:

  • the packager/labeller and the fabricator are GMP compliant;
  • the foreign establishment is GMP compliant and is listed on the Canadian Drug Establishment Licence (DEL);
  • the pharmaceutical product has a valid DIN or an NOC and a valid date of notification;
  • the pharmaceutical product is sold on the Canadian market”

When the pharmaceutical product is fabricated and/or packaged/labelled in Canada but not marketed in Canada, a CPP is issued if the following conditions are met:

  • the fabricator and/or packager/labeller are/is GMP compliant;
  • a DIN or an NOC has been issued, (that is the drug product has market authorization).”

For additional details on requirements for issuance refusal, the application process, and issuance of a certificate please see click here:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0024_doc-eng.php

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