Draft guidance on terms and conditions for human and veterinary drugs: Filing information and review

Filing information to fulfill terms and conditions indicates a change

The terms and conditions (T&Cs) letter may include several conditions, each with different timelines for completion. Where applicable, you, the market authorization holder (MAH), must submit the information required to fulfill the T&Cs by the date indicated in the letter.

In some cases, similar conditions may have been imposed in another country and the foreign regulator later removed these conditions. Regardless of the status of the conditions imposed in another country, you must fulfill your obligations under the Food and Drug Regulations (FDR) for the T&Cs imposed by Health Canada.

For subsequent-entry drugs, you are responsible to fulfill your T&Cs even if the reference product is no longer marketed. Reference product includes Canadian reference product (CRP) or Canadian reference biologic drug (CRBD). If you reference a CRP or CRBD with T&Cs imposed on its DIN, you should monitor the:

Notice of Compliance Database
Drug and Health Products Portal
Drug Product Database
product monograph brand safety updates (for human drugs only) and
most recent labels

If the information being filed indicates a change that may impact the drug's benefit-risk profile, labelling, or the drug's safety, efficacy or quality, file it using the appropriate submission type. Examples include:

supplemental new drug submission (SNDS)
drug identification number application (DINA)

For human subsequent-entry drugs comparing to a CRP, if the information being filed indicates changes that may impact the drug's labelling based on the CRP's fulfilling T&Cs, file it using an SANDS labelling only and not SANDS labelling only (generic drug).

For veterinary subsequent-entry drugs comparing to a CRP, if the information being filed indicates changes that may impact the drug's labelling based on the CRP's fulfilling T&Cs, file it using an SANDS.

In the case of drugs that have been authorized based on promising evidence of efficacy, final results from confirmatory trials should be filed in the form of an SNDS-confirmatory (SNDS-C) according to the individual deadlines outlined in the T&Cs letter. For more information on drug submissions based on promising evidence of efficacy, refer to:

Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions

You should file quality changes with a substantial or moderate potential to adversely affect the identity, strength, quality, purity or potency of a drug product as the appropriate post-authorization submission type. These factors may relate to the safety or effectiveness of the drug product.

You should still submit quality changes with minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency (level III changes).

For more information on determining which post-authorization submission type to use, consult the relevant guidance documents:

Filings may be subject to applicable fees. We will handle submissions in accordance with the following guidance documents:

For human drugs: Guidance on management of drug submissions and applications
For veterinary drugs: Management of regulatory submissions guidance
Regulatory Enrolment Process (REP) for Drugs for Human and Veterinary Drugs and Disinfectants

For post-market-related activities only, you can file as:

For human drugs:
- risk communication – pharmacovigilance (RC-PV)
- risk management plan – pharmacovigilance (RMP-PV)
- post-authorization commitments – pharmacovigilance (PA-PV)
- post-authorization act and regulations – pharmacovigilance (REG-PV)
- periodic benefit-risk evaluation report – pharmacovigilance (PBRER-PV)
- periodic safety update report – confirmatory (PSUR-C)
- periodic benefit-risk evaluation report – confirmatory (PBRER-C) or
- patient safety/advertising ad-hoc post-market request – pharmacovigilance (PSA-PV)
For both human and veterinary drugs:
- periodic safety update report (PSUR-PV)

The T&C letter may include more detailed instructions on how to file the information. Information filed to fulfill T&Cs should only address the T&Cs. It should not be filed as additional information to support an expanded indication or another significant change to the information in the original submission that is outside the scope of the T&Cs.

Filing information to fulfill terms and conditions does not indicate a change

You must file information to fulfill a T&C. This applies even if results from studies or information required by the T&C do not indicate a change to the safety, efficacy or quality since authorization that may impact the drug's benefit-risk profile or product labelling. Product labelling includes the product monograph (for human drugs) and package insert as well as package labelling.

If you submit information to fulfill a T&C but we determine that it does affect the information on which the authorization was based, we'll ask you to file the appropriate submission or application type. We'll do this if it might:

require a labelling change
impact the benefit-risk profile or
indicate a change in the quality of the product

Review of information filed

Once you file the information to fulfill the T&Cs, we will review the submitted information as per the performance standards in the applicable guidance documents:

For human drugs: Guidance on management of drug submissions and applications
For veterinary drugs: Management of regulatory submissions guidance

After reviewing the information submitted, we will inform you of the results. We will remove any T&Cs that are fulfilled, unless further conditions are imposed or existing conditions need to be amended. If further conditions are to be imposed, we will inform you through another anticipatory letter of what actions must be taken. You will be given up to 30 days to respond, unless specified otherwise.

New conditions may be imposed if, for example:

new risks or significant uncertainties are identified
more studies or activities are needed to address or manage the uncertainties
the existing T&Cs have not been adequately addressed or have not managed the identified or potential risks

We will consider other regulatory tools to address any identified issues. Depending on the nature of the issue, rather than imposing T&Cs we may, for example, request that you submit:

for human drugs:
- an annual summary report (ASR)
- an updated risk management plan (RMP)
- labelling updates to reflect new information
- a periodic safety update report (PSUR) or
- periodic benefit risk evaluation report (PBRER)
for veterinary drugs:
- labelling updates to reflect new information
- that you submit a PSUR

If the information or data you filed demonstrates an unfavourable change to the benefit-risk profile, we may take other regulatory actions such as cancelling a DIN. Examples of reasons for doing so include:

the drug is considered unsafe for the authorized indications
there isn't enough evidence to demonstrate that the drug will be effective under the conditions of use

Amending terms and conditions

The T&C letter will be amended as T&Cs are fulfilled, indicating the date on which the T&Cs were met. It will also be amended if T&Cs need to be modified, or additional T&Cs are to be imposed as a result of new information.

You may request an amendment to a T&C. Amendments may be requested if, for example, you conclude that a study imposed through a T&C cannot be completed for technical or scientific reasons. For example, if the date of submission of clinical trial results needs to be extended due to slower than anticipated enrollment or challenges with recruitment, or because a particular methodology is no longer feasible. If you request an amendment to a T&C, you must provide the basis for requesting an amendment with supporting rationale and documentation.

For changes related to technical or scientific issues, you may also be required to provide a scientific rationale. In such cases, you must include the proposed alternatives for fulfilling the T&Cs, including the proposed alternative methodology or study. We will review the information you provide and amend the T&C as appropriate.

To request an amendment, you may file details of the request with the rational to the appropriate directorate as indicated in the following guidance documents:

For human drugs: Guidance on management of drug submissions and applications
For veterinary drugs: Management of regulatory submissions guidance

Subsequent submissions for reasons other than to fulfill terms and conditions

Unfulfilled T&Cs continue to apply even if a new DIN is assigned as a result of subsequent submissions through post-authorization changes. Existing T&Cs may apply to the new DIN if:

the drug is authorized and a new DIN is assigned as a result of the subsequent submission or
the existing DIN is re-assigned under a new MAH or new brand name

This will depend on the nature of the new authorization and whether the T&Cs have yet to be fulfilled. In any case, if a new DIN is assigned, we will re-issue a T&C letter for unfulfilled T&Cs that will apply to the new DIN.

For more information on post-authorization changes, refer to:

Subsequent entry drug submissions may reference drugs that have T&Cs imposed on its DIN. We will treat these subsequent entry submissions as follows:

Supplemental (Level 1) changes that rely on the safety and efficacy data of the original submission (for which authorization was granted with T&Cs) will be treated as SNDSs, SANDS or DIN applications. If a new DIN is assigned, T&Cs may be imposed if prior DINs for that drug had T&Cs. An example would be a submission for a change in strength or formulation. The imposition of T&Cs on the new DIN will be decided following consideration of the following factors if:
- the T&Cs are technically feasible
- there is a less burdensome way of meeting the objectives of T&Cs and
- another regulatory mechanism could address the issues identified
T&Cs will remain in place if a product undergoes an administrative change (such as a change in product name or manufacturer name) but continues to rely on the safety, efficacy and quality data of the original submission.
Administrative changes to subsequent-entry drugs which rely on the safety and efficacy data of the original submission will carry over any unfulfilled T&Cs from the original submission. In such cases, if a new DIN is assigned, we will re-issue a T&Cs letter for the appropriate DIN.
T&Cs will continue to apply, even if subsequent changes (through supplements to drug submissions and applications) that are filed and authorized don't result in new T&Cs. Depending on the outcome of the review, subsequent submissions may qualify for authorization, with or without new T&Cs.
If we revoke or suspend the original NOC for a drug with T&Cs, including for drugs that used a reference product with T&Cs, we may take appropriate action for all subsequent submissions. Additional T&Cs that have been imposed specifically on the subsequent-entry drugs (that is, in addition to the conditions of the original drug), will continue to apply and must be fulfilled (unless they are otherwise amended or removed).

If you need clarification on filing and processing subsequent submissions, contact the appropriate review area listed within the following guidance documents:

For human drugs: Guidance on management of drug submissions and applications
For veterinary drugs: Management of regulatory submissions guidance

T&Cs may apply to the DIN of a cross-licensed product if the licensor's drug had T&Cs imposed on its DIN. For more information on administrative processing of drug submissions, refer to:

Guidance document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs (while veterinary drugs are not in the scope of this document, it can be used as a reference)

When all conditions are fulfilled

Once you've provided satisfactory evidence that all the objectives of the T&Cs in the original (or amended) T&C letter have been met, Health Canada will issue a final letter. It will reference the DINs on which the T&Cs were imposed and:

indicate that the T&Cs have been fulfilled and
state that the T&Cs are removed

In the case of subsequent-entry drugs for which the T&Cs of the CRP or CRBD have been fulfilled, the T&Cs for the subsequent-entry drug will usually be considered fulfilled if the generic or biosimilar drug had similar T&Cs imposed depending on the nature of the T&C.

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2025-12-12

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