Guide to the environmental risk management authorities under the Food and Drugs Act: Authority to order a label change or package modification

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• Section 21.302
• Authority to order a label change or package modification to prevent a serious risk to the environment
• Process for making an order to change a label or package

Section 21.302

This section of the Food and Drugs Act (FDA) sets out the authority to order a label change or package modification to prevent a serious risk to the environment.

Section 21.302, authority to order a label change or package modification to prevent a serious risk to the environment:

“The Minister may, if he or she believes that doing so is necessary to prevent a serious risk to the environment, order the holder of a therapeutic product authorization that authorizes the import or sale of a therapeutic product to modify the product’s label or to modify or replace its package.”

Authority to order a label change or package modification to prevent a serious risk to the environment

Scope

Section 21.302 of the FDA applies to therapeutic products only.

Any authorization holder that imports or sells a therapeutic product can be subject to this authority.

This authority allows the Minister to make an order requiring an authorization holder to change the label or replace or change a package for therapeutic products used in:

• clinical trials
• experimental studies certificates or
• market authorization applications

For example, the Minister may require that a label be revised to:

• include new information (for example, a new warning) regarding the risk to the environment or
• indicate environmental handling requirements or an appropriate disposal method or time (for example, summer/winter, rain/sun) for when the therapeutic product should be used

About the threshold that needs to be met before using this authority

The Minister can only use this authority if they believe that doing so is necessary to prevent a serious risk to the environment from a therapeutic product.

Health Canada assesses therapeutic products for their safety, efficacy and quality before they are available for sale in Canada. However, information about the environmental risks or harms associated with the use or disposal of a therapeutic product may become available after the product is already on the market. This may result in the label not adequately reflecting this new information.

For further discussion on additional elements to consider before exercising this authority refer to “Key considerations for managing risks to the environment.”

Process for making an order to change a label or package

Before making an order under section 21.302 of the FDA, the minister, with support from officials, must ensure the threshold has been met and that the order meets the policy objectives. They will conduct scientific, policy and regulatory analyses to ensure these criteria are met.

Notification and opportunity to respond

When we are considering an order under this authority, we will consult, when applicable, with the relevant parties. In addition, in general, before making an order, we would provide prior notification to the authorization holder subject to the order. However, in urgent or exceptional circumstances, we may not provide a notification.

The notification would:

• inform the authorization holder that the Minister believes that the therapeutic product label or package requires modification to prevent a serious risk to the environment
• set out the facts and the relevant criteria used to form the basis of this belief and
• give the authorization holder the opportunity to voluntarily change the product’s label or packaging

Unless circumstances warrant otherwise, the notification would also provide the affected authorization holder with a reasonable opportunity to:

• correct an error in fact
• dispute the proposed exercise of the authority or
• voluntarily comply with the measures outlined in the notification

The notification may also specify the timeframe in which the authorization holder must respond. The severity and immediacy of the risk presented by the therapeutic product would determine the timeframe.

The Minister can issue an order whether they have previously notified the authorization holder or not. For further discussion, refer to “Sufficient notice.”

Development of the order

An order made under section 21.302 of the FDA is not a statutory instrument as defined in the Statutory Instruments Act. Therefore, the Minister may delegate the making, amending or revoking of an order to officials, as appropriate.

If we determine that an order under these authorities is the best option to address the issue, officials will conduct the necessary analysis to support its development.

We will consult with relevant stakeholders during the development of the order. These consultations may take different forms depending on such things as the number of stakeholders who are affected or the urgency of the situation.

An order made under section 21.302 of the FDA to an authorization holder would include the following:

• the name of the authorization holder or authorization holders it applies to
• the legislative authority being relied on
• the name of the therapeutic product and/or relevant authorization that is subject to the order including, for example, any relevant details such as the:
  • lot number
  • manufacturing site
• the risk to the environment that will be mitigated by changing the label or packaging (if known, the areas of the label to change)
• the timeframe for completing the ordered label or packaging changes or modifications and
• the consequences of contravening the order

We may develop supporting regulations at a later date.

Publication

In accordance with subsection 21.4(2) of the FDA, the order has to be made public. Where necessary, we may redact certain information before publishing an order, for example, to protect confidential business information.

We will also make supporting information public. This will include the reason for making the order as well as an explanation of the basis for the decision and how it was reached. Supporting information may include:

• a narrative and chronological review of the facts
• the scientific evidence or other new evidence considered
• any findings on important questions of fact and the accompanying analysis applying the facts to the law
• any relevant criteria considered as part of the threshold determination and
• an explanation of how the evidence satisfies the threshold

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