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Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities (power to require & disclose information, power to order a label change and power to order a recall)

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Notice to the reader: The online consultation is now closed. The final guidance is available now.

The Amendments to the Food and Drugs Act: Guide to New Authorities was developed to help Health Canada implement the new authorities that came into force upon royal assent of Bill C-17, the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), on November 6, 2014, including:

  • The Minister's authority to require and disclose information
  • The Minister's authority to order a label change/package modification, and
  • The Minister's authority to order a recall

The guide sets out principles, policy, and standards to follow when Health Canada identifies situations in which it may be appropriate for the Minister to exercise these new authorities.

Specifically, the guide:

  • Sets out guiding principles that should govern all decisions made by Health Canada acting as a regulatory decision-maker;
  • Covers "when", "how", and "what" triggers the Minister's ability to make use of these authorities and explains to "whom" the authorities apply.
  • Increases the consistency and predictability for both health and industry as to how the authorities will be applied, resulting in improved quality of regulatory decision-making and improved compliance.

The guide is also intended to support the development of the operational tools [e.g., standard operations procedures (SOPs), guidance documents, process maps, templates] needed for those authorities which came into force immediately upon royal assent. It will also guide future regulatory and operational development for those authorities which require accompanying regulations.

As a guidance document and administrative tool, the guide should be read in conjunction with the amended Food and Drugs Act and the Food and Drug Regulations.

The Guide to New Authorities is already in use by Health Canada but stakeholder comments on the clarity of the document will be considered before the document is finalized.

Health Canada will develop regulatory proposals in support of the amendments to the Food and Drugs Act in keeping with the Regulatory Policy set out by the Government of Canada. Stakeholders will have an opportunity to participate in developing regulations in support of the new authorities as part of the regulatory development consultation process.

How to Get Involved

This consultation is open for comment until June 8, 2015. Please select and read through the link below titled "consultation document". Stakeholders are asked to review the information carefully and to provide their comments on the draft implementation guide, in writing, to the address below before June 8, 2015.

LRM_MLR_consultations@hc-sc.gc.ca

Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
5th floor, Address Locator 3105A
Ottawa, ON K1A 0K9

Telephone: 613-957-0374
Facsimile: 613-941-7104

Interested parties are encouraged to provide comments and suggestions by June 8, 2015.

Reporting to Canadians

Health Canada will make the results of this consultation available on this web site.

If you have any questions, contact us at Office of Legislative and Regulatory Modernization.