Draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product

Draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product (Word Format, 86 KB)

For information on significant change, refer to Guidance on preparing and submitting summary reports for marketed drugs and natural health products

All fields indicated by an asterisk (*) are mandatory.

If you have already notified us of a significant change, you do not need to notify us again, unless there is new information that represents another significant change.

Section 1: Products information

* Relevant unique Canadian identifiers (DIN, NPN, DIN-HM): (required)

* Name(s) of relevant Canadian product(s):

* Type of product (required)

• human pharmaceutical (prescription)
• human pharmaceutical (non-prescription)
• human biologic
• radiopharmaceutical
• natural health product
• combination product (drug and device) for human use

* For drugs, dossier ID of relevant Canadian product(s):   [For natural health products, insert N/A] (required)

Note: you must submit one form per dossier ID if multiple products are affected.

Section 2: Significant change

* Concise description of safety finding that led to the conclusion of a significant change, including clinical impact on patient or public health: (required)

Brief description of the evidence of the safety finding that led to the conclusion of a significant change:

* Impact of the significant change on what is known about the benefits and risks of the product: (required)

Period covered by the last completed Annual Summary Report (yyyy-mm-dd to yyyy-mm-dd):

Period covered by the annual summary report in progress (yyyy-mm-dd to yyyy-mm-dd):

Sections of the Annual Summary Report discussing the significant change:

Section 3: Action(s) to be taken in Canada

Actions intended to be taken in Canada by the MAH or licence holder

• submit a risk management plan or an updated risk management plan
• file a supplement to a submission for drugs or an amendment and notification form for NHPs (change to labelling, packaging, indication, etc.)
• issue a risk communication (warning, dear HCP)
• change promotional or educational material
• change product design
• change product accessibility (controlled access, distribution)
• stop sale in Canada
• recall from the Canadian market
• discontinue the product in Canada
• other (please specify):

Provide details of the actions intended to be taken, including timing (if available):

If the MAH or licence holder will not be taking the needed action in Canada at this time, provide details and a rationale of the action needed and the reason the MAH or licence holder will not be taking that action (e.g. action needed first by innovator company; action needed by regulator):

Section 4: Contact information

* Market authorization holder (MAH) or licence holder in Canada: (required)

Canadian importer (if different from the market authorization holder or licence holder):

* Contact email address for MAH or licence holder: (required)

* Contact phone number for MAH or licence holder: (required)

For drugs, notifying Health Canada of a significant change must be done using this PDF form. Submit this form in Electronic Common Technical Document (eCTD) or non-eCTD format via the Electronic Submissions Gateway (ESG) using Regulatory Enrolment Process (REP). Place the form in Canadian Module 1, Section 1.3.8.4

For Natural Health Products, submit this form via Canada Post’s secure email service, ePost Connect.