Guidance: How to demonstrate foreign building compliance with drug good manufacturing practices

From Regulatory Operations Regions Branch

Overview

This guide provides guidance on the type of information Canadian importers should submit to list a foreign building on their drug establishment licence (DEL).

Important notice

All Canadian importers must hold a valid Drug Establishment Licence (DEL) for the activity of importation.

Who this guide is for

  • Canadian importers
  • Consultants
  • People thinking about becoming Canadian importers

In this guide

About this document

  • 1 Purpose
  • 2 Scope
  • 3 Introduction

Guidance

  • 4 Listing foreign buildings
  • 5 Recommended GMP evidence
  • 6 Requesting an extension of the NERBY date
  • 7 Health Canada on-site assessment of a foreign building

Appendices

  • Appendix A - Glossary
  • Appendix B - References
  • Appendix C - Questions and answers
  • Appendix D - Summary of Health Canada process

View complete guide

Details and history

Published: January 18, 2018

Updated: January 18, 2018

Consulted: January 18, 2017- April 18, 2017

For assistance

By email

Contact us by email:

foreign_site_etranger@hc-sc.gc.ca

Service standards: We answer to mail within 10 business days. If we can't answer your question right away. We will send you an estimate date.

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