Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law): Sufficient notice (Annex B)

Affected parties may benefit from receiving notice of the Minister's intention to issue an Order against them so that they have an opportunity to be heard. For the purposes of procedural fairness, a notice should contain the following elements, depending on the circumstances:

• a reference to the section of the Food and Drugs Act (Act) by which the Minister derives the ability to issue the Order
• the therapeutic product subject to the notice
• scientific evidence that relates to the issue that needs to be addressed (such as a summary of the history and facts that the regulator intends to rely upon to issue the Order)
• the criteria that the regulator will use to determine the threshold has been met, including any relevant findings on important questions of fact, and the analysis used to form the basis for the conclusions reached
• the proposed necessary action the party should take to resolve the issue
• a specified reasonable timeframe for the affected party to take action to resolve the issue (this may vary depending upon the immediacy of risk that the product presents: 12 hours, 2 business days, 90 days and so on)
• a specified reasonable timeframe proposed for the affected party to respond to the notification should they want to make representations (this may vary depending upon the severity and immediacy of the risk that the product presents: 12 hours, 2 business days, 90 days and so on)
• a statement that the Minister reserves the right to extend the timeframe for the therapeutic product authorization holder to take action

Issuing a notification does not limit or prevent the Minister from exercising the power to issue an Order. In general, a notice would be provided because the Orders may adversely impact the regulated persons. However, in urgent or exceptional circumstances, the notice may not be provided or may be dispensed with.