Guidance document on the application for a certificate of a pharmaceutical product and good manufacturing practice certificate (GUI-0024) - Summary

Overview

The purpose of this guide is to help applicant understand how to apply for a good manufacturing practices (GMP) certificate and a certificate of a pharmaceutical product (CPP). This guidance document clarifies the requirements to be met for the issuance of a Certificate of a Pharmaceutical Product (CPP) or a Certificate of Good Manufacturing Practices (GMP) and describes the procedure for their request.

Who this guide is for

1. Any World Health Organization member state
2. Any Drug identification Number (DIN) owner of a pharmaceutical product; or in the case of radiopharmaceuticals any party to which a Notice of Compliance (NOC) has been issued
3. Any Canadian pharmaceutical product fabricator that is GMP compliant;
4. Any third party who is submitting an application for any of the parties mentioned above.

In this guide

• 1.0 Purpose
• 2.0 Scope
• 3.0 Background
• 4.0 Applying for a certificate
  • 4.1 Application requirements
  • 4.2 Conditions when a certificate will be refused
  • 4.3 How to apply (steps)
  • 4.4 Issuance of a certificate
• Appendix A - Glossary
  • Acronyms
  • Terms
• Appendix B - References
• Appendix C – Forms
  1. Application Form for a Certificate of a Pharmaceutical Product
  2. Request for a Certificate of a Pharmaceutical Product application instructions
  3. Fee Form Certificate of a Pharmaceutical Product
  4. Request for stamping form
  5. Application form for a GMP Certificate
  6. GMP Certificate application form instructions

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Download PDF (358 KB, 25 pages)

Details and history

• Published: April 1, 2020
• Updated: April 1, 2020
• Consulted:
• Part of topic(s):

For assistance

Contact us by mail:

Drug Establishment Licensing Unit
Health Product Compliance Directorate - Regulatory Operations and Regions Branch
Jeanne Mance Building, 13th floor
200 Eglantine Driveway
Address Locator #1913B
Ottawa, Ontario
K1A 0K9

By email:

HC.cpp.questions.SC@canada.ca

Service standards: We answer to mail within 15 business days. If we can't answer your question right away. We will send you an estimate date.