Health Canada (HC) recognizes the significant impact the COVID-19 pandemic has had on the global pharmaceutical product supply chain and strains it has put on both the pharmaceutical industry as well as international regulatory bodies.
To continue to meet the requirements of the voluntary agreement set out in the WHO Certification scheme on the quality of pharmaceutical products moving in international commerce during this pandemic, HC is launching a pilot to implement the electronic issuance of Certificates of a Pharmaceutical Product (CPP) and Good Manufacturing Practices (GMP) Certificates effective as of October 5th, 2020. Furthermore, as of today, Heath Canada will no longer be sending electronically signed interim letters. This pilot is replacing the standard paper-based process in that no paper copies of electronically-issued CPPs and GMP Certificates will be available.
Why is HC launching this pilot?
This pilot to implement the electronic issuance of CPPs and GMP Certificates (i.e. issue “e-CPPs” and “e-GMP Certificates”) will offer the following benefits:
- To continue to provide this critical service during the COVID-19 pandemic by using secure electronic signature features as recommended by the WHO,
- A “greener” process for receiving applications and issuing e-CPPs and e-GMP Certificates with the elimination of paper usage, and
- A more efficient and stream-lined process to issue e-CPPs and e-GMP Certificates and share with our international partners.
To prevent issues with obtaining your e-CPP or e-GMP Certificate, you are responsible for notifying HC of any change in your contact information on your application, including e-mail and mailing addresses. To update your contact information, please email hc.cpp.questions.sc@canada.ca.
What is new?
- All aspects of the CPP and GMP Certificate application will be handled electronically; which means applications can only be submitted electronically.
- Applicants will be required to submit new forms to process the CPP and GMP certificate applications and to process payment.
- All e-CPPs and e-GMP certificates will be signed with an electronic signature that uses a certificate-based digital ID to authenticate the signer’s identity and demonstrate proof of signing. The certificate will also be locked:
- to protect the integrity of the certificate and prevent any modifications to the document after signature.
- to prevent the content in the certificate from being copied.
- A Letter of Authorized Signatories is also provided, with the certificate, to confirm the identity of the designated signatories.
- Due to the limited nature of this pilot, all copies of product information, including: product labels, product information, product monographs, lists of excipients and Request for Stamping Form, normally submitted to support an application for a certificate and intended to be appended to the certificate, will not be accepted until further notice. For this same reason, Requests for Affidavits will also not be accepted until further notice.
To receive a copy of detailed instructions on the new e-CPP and e-GMP Certificate process and/or new forms, please contact the Drug Establishment Licensing Unit by email at: hc.cpp.questions.sc@canada.ca.
The new instructions and form will be attached to the autoreply message effective October 5th, 2020.
How long will this pilot last and where do I send feedback during its implementation?
HC is launching this pilot immediately and for the duration of the pandemic, and we will monitor its implementation so that adjustments can be made as required. We invite you to share any feedback you may have regarding this pilot implementation that could help ensure an effective, long-term process, by writing to hc.cpp.questions.sc@canada.ca.
Contact:
Health Product Inspection and Licensing Division
E-mail:hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca
Telephone: 613-957-1492