Guide to the environmental risk management authorities under the Food and Drugs Act: Authority to recall the product
- Overview
- Authority to require and disclose information
- Authority to order a label change or package modification
- Authority to recall the product
- Authority to compile information or require tests, studies or monitoring
- Determining risk to the environment
- Key considerations for managing risks to the environment
On this page
- Section 21.303
- Authority to recall a product when there is a serious or imminent risk to the environment
- Process for making an order to recall a product
Section 21.303
The following subsections of the Food and Drugs Act (FDA) set out the authority to recall a product.
Subsection 21.303(1), authority to recall a product when there is a serious or imminent risk to the environment
“If the Minister believes that a therapeutic product presents a serious or imminent risk to the environment, he or she may order a person who sells the product to:
- (a) recall the product or
- (b) send the product, or cause it to be sent, to a place specified in the order”
Subsection 21.303(2)
“Subsections 21.3(2) to 21.3(6) apply, with any modifications that the circumstances require, in respect of any order made under subsection (1).”
Subsection 21.3(2), recall order when corrective action is needed
“For greater certainty, if the Minister makes an order under paragraph (1)(a) and believes that corrective action is an effective means of dealing with the risk, the order may require the person who sells the product to, instead of requesting the product’s return, request the product’s owner or user to allow corrective action to be taken in respect of the product and then take that corrective action, or cause it to be taken, if the request is accepted.”
Subsection 21.3(3), prohibition on selling
“Subject to subsection (5), no person shall sell a therapeutic product that the Minister orders them, or another person, to recall.”
Subsection 21.3(4), authority to authorize sale
“The Minister may authorize a person to sell a therapeutic product, with or without conditions, even if the Minister has ordered them, or another person, to recall it.”
Subsection 21.3(5), exception
“A person does not contravene subsection (3) if they sell a therapeutic product that they have been authorized under subsection (4) to sell, provided that they sell it in accordance with any conditions that the Minister establishes.”
Subsection 21.3(6), contravention of unpublished order
“No person shall be convicted of an offence for the contravention of subsection (3) unless it is proved that, at the time of the alleged contravention, the person had been notified of the recall order or reasonable steps had been taken to bring the purport of the recall order to the notice of those persons likely to be affected by it.”
Authority to recall a product when there is a serious or imminent risk to the environment
Scope
Section 21.303 of the FDA applies to therapeutic products only.
Any person who sells a therapeutic product can be subject to this authority.
Subsection 21.303(1) of the FDA allows the Minister to make an order requiring a person selling a therapeutic product to recall it and remove it from the marketplace, if the product is believed to present a serious or imminent risk to the environment. The order may also require the therapeutic product be sent to a particular place that the Minister specifies, for example, a warehouse for examination or quarantine.
Subsection 21.3(2) of the FDA allows the Minister to make an order requiring the person who sells the therapeutic product to take corrective action rather than having the product returned if the Minister believes that this is an effective means of dealing with the environmental risk.
Subsection 21.3(3) of the FDA indicates that no person shall sell a therapeutic product that has been ordered to be recalled.
Subsection 21.3(4) of the FDA allows the Minister to authorize a person to sell a therapeutic product, that is subject to a recall order, with or without conditions. In this case, recalling a therapeutic product would pose a greater risk to health than the reason for recall. An example is the permitted sale of a life-saving drug to a small subset of patients for whom no alternative is available, despite there being a known serious or imminent risk to the environment.
Subsection 21.3(5) of the FDA indicates that a person does not contravene the act if they sell a recalled therapeutic product if the Minister has authorized the person to sell it, with or without conditions, under subsection 21.3(4) of the FDA.
Subsection 21.3(6) of the FDA indicates that no person shall be convicted of an offence for contravening the act if the person was not notified of the recall order or if reasonable steps had not been taken to bring the purpose of the recall to the attention of people likely to be affected by it.
About the threshold that needs to be met before using these authorities
The Minister can only use these authorities if they believe that a therapeutic product presents a serious or imminent risk to the environment. For further discussion on determining whether an authorized therapeutic product presents a risk to the environment, refer to “Determining risk to the environment.”
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 recall a product
Before making an order under subsection 21.303(1), 21.3(2) or 21.3(4) 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 person who sells the therapeutic product subject to the order. However, in urgent or exceptional circumstances, we may not provide a notification.
The notification would:
- inform the person who sells the therapeutic product that the Minister believes it presents a serious or imminent risk to the environment and that an order is being proposed to recall the therapeutic product
- set out the facts and the relevant criteria used to form the basis of this belief and
- give the person who sells the therapeutic product the opportunity to voluntarily recall it
Unless circumstances warrant otherwise, the notification would also provide the affected person 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 person who sells the therapeutic product 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 person who sells the therapeutic product or not. For further discussion, refer to “Sufficient notice.”
Development of the order
An order made under subsection 21.303(1), 21.3(2) or 21.3(4) 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 subsection 21.303(1), 21.3(2) or 21.3(4) of the FDA to the person who sells the therapeutic product would include the following:
- the name of the person or persons 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:
- lot number,
- manufacturing site
- a request for the person to provide a recall plan satisfactory to the minister
- other instructions for conducting the recall (such as taking corrective action, performing effectiveness checks), including, if necessary, the site to which the recalled therapeutic product will need to be sent
- the timeframe for responding to the order and conducting the above activities 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 a person’s privacy or 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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