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

Related acts and regulations

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 guide also contains the required forms that applicants will need to submit an application to Health Canada to get a CPP and GMP certificate.

Who this guide is for

  1. Any World Health Organization member state
  2. Any Drug Identification Number (DIN) owner of the pharmaceutical product; or in the case of radiopharmaceuticals any party to which an 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. About this document
  2. Guidance
  3. Appendices

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Download PDF (822 KB, 20 pages)

Details and history

Published: April 1, 2018

Updated: April 1, 2018

Consulted:

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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

By phone or fax:

Telephone: 613-618-4529
Facsimile: 613-957-4147

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.

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