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Draft guidance on terms and conditions for human and veterinary drugs: Terms and conditions letters

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Anticipatory terms and conditions letter

Health Canada will inform you (the market authorization holder [MAH] or sponsor of the drug submission) of our intent to impose terms and conditions (T&Cs). We will do so by issuing an anticipatory T&Cs letter ("anticipatory letter").

The anticipatory letter will:

Timing for issuing an anticipatory terms and conditions letter

T&Cs can be imposed at any time on a DIN assigned to a drug; therefore, there is flexibility on when the anticipatory letter may be issued. If T&Cs are needed because of an issue that arises during pre-market submission review, the timing of the anticipatory letter will depend on the nature of the issue(s) to be addressed and the details of the pre-market submission under review, as applicable.

T&Cs may also be imposed on a DIN(s) of a drug that has already been authorised for a long period of time. The anticipatory letter may be issued either:

If T&Cs are needed because of an issue identified during review, an anticipatory letter may be issued at different times depending on the progress of review and the issues to be addressed. For example, in cases where the activities under the T&Cs must be implemented immediately upon marketing the product, an anticipatory letter may be issued during the review period (Figure 1). It could also happen if certain elements of the T&Cs are to be included in product labels, such as the product monograph (Figure 1).

For drug submissions based on promising evidence of efficacy where the Minister may consider T&Cs as part of the review as per section C.08.003.2 of the FDR, the anticipatory letter will be issued during the review. For more information on drug submissions based on promising evidence of efficacy, including timing of the anticipatory letter, refer to:

Figure 1: Anticipatory letter issued during review of a pre-market submission
Figure 1
Figure 1: Text description

Anticipatory letter issued during review of a pre-market submission

Sponsors file the submission or application, which undergoes screening. If it's not accepted for review, a screening deficiency notice may be issued. If it's accepted at screening, it will enter review. Possible outcomes following review are an issuance of:

  • notice of compliance (NOC)
  • drug identification number (DIN) assignment
  • notice of deficiency (NOD) or
  • notice of non-compliance (NON) (for human drugs only)

If we determine that T&Cs on the DIN are needed, we'll issue an anticipatory T&C letter during the review. The sponsor will be given up to 30 days to respond. Based on the review of the response, we'll decide whether or not to impose T&Cs. If T&Cs are needed, we will issue a final T&C letter to the sponsor. Should the sponsor fail to respond to the anticipatory letter, we may finalize the T&Cs based on the information available to us. The issuance of the NOC is not dependent on the review of the response to the anticipatory T&C letter.

Figure 2: Anticipatory letter issued at the time of authorization, upon issuance of a NOC and DIN assignment
Figure 2
Figure 2: Text description

Anticipatory letter issued at the time of authorization, upon issuance of a NOC and DIN assignment

Sponsors file the submission or application and it undergoes screening. If it's not accepted for review, we may issue a screening deficiency notice. If it's accepted at screening, it will enter review. Possible outcomes following review are an issuance of:

  • notice of compliance (NOC)
  • drug identification number (DIN) assignment
  • notice of deficiency (NOD) or
  • notice of non-compliance (NON) (for human drugs only)

If we determine that T&Cs on the DIN are needed, we'll issue an anticipatory T&C letter with the market authorization. The sponsor will be given up to 30 days to respond. Based on the review of the response, we'll decide whether or not to impose T&Cs. If T&Cs are needed, we'll communicate this to the sponsor in a T&C letter within 30 days. Should the sponsor fail to respond to the anticipatory letter, we may finalize the T&Cs based on the information available to us. The issuance of the NOC is not dependent on the review of the response to the anticipatory T&C letter.

Figure 3: Anticipatory letter issued shortly after issuance of a NOC and assignment of a DIN
Figure 3
Figure 3: Text description

Anticipatory letter issued shortly after issuance of a NOC and assignment of a DIN

Sponsors file the submission or application and it undergoes screening. If it's not accepted for review, we may issue a screening deficiency notice. If it's accepted at screening, it will enter review. Possible outcomes following review are an issuance of:

  • notice of compliance (NOC)
  • drug identification number (DIN) assignment
  • notice of deficiency (NOD) or
  • notice of non-compliance (NON) (for human drugs only)

If we determine that T&Cs on DIN(s) are needed, we'll issue an anticipatory T&C letter following authorization and the sponsor will be given up to 30 days to respond. Based on the review of the response, we'll decide whether or not to impose T&Cs on the DIN. If T&Cs are needed, we'll communicate this to the sponsor in a T&C letter within 30 days. Should the sponsor fail to respond to the anticipatory letter, we may finalize the T&Cs based on the information available to us. The issuance of the NOC is not dependent on the review of the response to the anticipatory T&C letter.

Figure 4: Anticipatory letter issued for an authorized product because of new information
Figure 4
Figure 4: Text description

Anticipatory letter issued for an authorized product because of new information

At any point following market authorization, new information could trigger the need for T&Cs. Health Canada will issue an anticipatory T&C letter and the sponsor will be given up to 30 days to respond. Based on our review of the response, we'll decide whether or not to impose T&Cs on the DIN(s). If T&Cs are needed, we will communicate them to the sponsor in a T&C letter within 30 days. Should the sponsor fail to respond to the anticipatory letter, we may finalize the T&Cs based on the information available to us.

Response to anticipatory terms and conditions letter

You should respond to the anticipatory letter in writing and include the details of a plan to fulfill the T&Cs. Generally, you should submit the response within 30 calendar days of receiving the anticipatory letter, or as specified in the letter. Should you fail to respond to the anticipatory letter, we may finalize the T&Cs based on the information available to us.

If a new risk or uncertainty is identified that requires urgent attention for an authorized and marketed drug, the time to respond may be reduced.

If the T&Cs are the result of pre-market submission review, your response to an anticipatory letter should:

If the proposed T&Cs require you to conduct more studies or activities, you will have an opportunity to provide:

If you object to the proposed T&Cs, you may provide reasons for your objections. You may:

You may also request to meet with us to discuss your objections.

Terms and conditions letter

We will review your response within 30 calendar days of receiving it. We will review information you provide and refer to any other information that could inform the review. During this review, we may request clarification in accordance with the following guidance documents:

Following the review, if T&Cs are still needed, we will finalize the T&Cs in a letter that will specify the:

As per subsection C.01.014.21(2), we will notify you of the final T&Cs by sending you the final T&C letter. For drug submissions based on promising evidence of efficacy and within the scope of C.08.003.2, the T&Cs will be considered during review. The "terms and conditions letter" will be issued to the manufacturer with the notice of compliance (NOC) at the end of review.

For more information on drug submissions based on promising evidence of efficacy, refer to:

Transparency

After issuing a T&Cs letter, we'll post information related to the T&Cs on the Health Canada website. Details will include statements on the T&Cs imposed and their timelines. We'll update this information as T&Cs are fulfilled or amended. The information posted will not contain any confidential business information. It's imperative to the safe and effective use of a drug that information concerning T&Cs be readily available to patient groups, health care providers and other interested stakeholders.

In addition to the T&C information, you can find the following information online:

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2025-12-12