Establishment Licence Application Completion Checklist

Contact Information

Our Mandate :

To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Checklist

Please ensure that the following information is attached before submitting your application package.

• Application Form
• Fee Form
• Payment
• Calculation Chart (Please email the Establishment Licence Invoicing Unit in order to obtain the instructions as well as the Calculation Chart at ELIU_UFLE@hc-sc.gc.ca)
• Emergency Contact information Form

If applicable

• Alternate Sample Retention Site Form
• Foreign Site Good Manufacturing Practices (GMP) evidence
• Section 37 Form

Name and Signature of Company Contact

Date: