Pilot for issuing electronic certificates for pharmaceutical products and good manufacturing practices

Drug Establishment Licensing Bulletin 96, October 1, 2020

On this page

• Background
• Why we’re launching the pilot
• What’s new
• Contact us

Background

Health Canada recognizes the significant impact the COVID-19 pandemic has had on the global pharmaceutical product supply chain. Both the pharmaceutical industry and international regulatory bodies have felt the strain.

The World Health Organization established a certification scheme on the quality of pharmaceutical products moving in international commerce (PDF) during this pandemic. To continue to meet the requirements of this voluntary agreement, Health Canada launched a pilot to issue electronic certificates for a pharmaceutical product (CPP) and good manufacturing practices (GMP).

The pilot takes effect on October 5, 2020, and will last for the duration of the pandemic.

As of today, we are no longer sending electronically signed interim letters.

This pilot replaces the standard paper-based process. Paper copies of electronically issued CPP and GMP certificates will no longer be available.

We will monitor the pilot and make adjustments as required.

Why we’re launching the pilot

This pilot to issue “e-CPP” and “e-GMP” certificates will offer the following benefits:

• continue to provide this critical service during the COVID-19 pandemic by using secure electronic signature features recommended by the WHO
• a “greener” process that eliminates paper
• a more efficient and streamlined process and the ability to share with our international partners

What’s new

Here’s what you need to know:

• applications may only be submitted electronically
• applicants must submit new forms to process the CPP and GMP certificate applications and to process payment
• e-CPP 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
• certificates will be locked to:
  • protect the integrity of the certificate
  • prevent any modifications to the document after they have been signed
  • prevent the content in the certificate from being copied

We are also providing a letter of authorized signatories with the certificate to confirm the identity of the designated signatories.

Note: During the pilot phase, we will not be accepting copies of product information that are normally submitted to support an application for a certificate. This includes:

• product labels
• lists of excipients
• product information
• product monographs
• the request for stamping form

Requests for affidavits will also not be accepted until further notice.

Contact us

You may contact us at the Drug Establishment Licensing Unit to:

• update your contact information
• share your feedback about this pilot
• receive detailed instructions on the new e-CPP and e-GMP certificate process and/or new forms

Email us at hc.cpp.questions.sc@canada.ca.