Draft form: Notifying Health Canada of foreign actions in respect of a serious risk of injury to human health (GMP or manufacturing site, product quality, product recall)

Draft form: Notifying Health Canada of foreign actions in respect of a serious risk of injury to human health (GMP or manufacturing site, product quality, product recall) (Word Format, 1.6 MB)

Food and Drug Regulations, C.01.050
All fields indicated by an asterisk (*) are mandatory

* Relevance of notification to Canada? (required)

• issue with same or similar medicinal ingredient(s) or molecule(s)
• related site
• affected product authorized and distributed in Canada
• manufacturing issue at a domestic or foreign site in the supply chain
• other

CONTACT INFORMATION

* Email address for confirmation of submission (required)
This address will receive a record of your submitted form

* Drug Market Authorization Holder (MAH) (required)

Canadian importer (if different from the MAH)

* MAH contact's email address (required)

* MAH contact's phone number (required)

PRODUCT(S) INFORMATION

* DIN(s) of relevant Canadian product(s) (required)

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

Type of product(s)

• human pharmaceutical
• human biologic
• veterinary pharmaceutical

Batch/Lot Number(s) of relevant Canadian product(s) (if applicable and if known)

Expiration date of relevant Canadian product(s) (if applicable and if known)
(YYYY-MM-DD)

ACTION(S) TAKEN IN FOREIGN JURISDICTION

* Action(s) taken in foreign jurisdiction in respect of serious risks to human health (required)

• risk communicated by foreign authority
• risk communicated by authorization holder
• label change
• recall
• reassessment of product authorization
• suspension or revocation of site license
• suspension or revocation of market authorization

Action(s) taken in the foreign jurisdiction by

• foreign regulatory authority
• authorization holder (required by regulatory authority)
• authorization holder (voluntary)

Details of action(s) taken in the foreign jurisdiction

Link(s) to online information about the action

Brand name of the foreign product

* A brief description of the serious risk of injury to human health that gave rise to the foreign action, including when it occurred (required)

A brief description of the evidence of the risk that triggered the foreign action (if available)

* Source of risk that triggered the foreign action (required)

• GMP or manufacturing site
• Product quality / recall

* Name of manufacturer or authorization holder in the foreign jurisdiction (required)
(200 characters)

* Foreign jurisdiction(s) where action(s) taken (required)

Foreign site/address where the issue arose, if different from the manufacturing site (if applicable and known)

ACTION(S) TAKEN IN CANADA

How the issue will be addressed in Canada

• Action(s) already taken in Canada (specify and provide details)
• Action(s) intended to be taken in Canada (specify and provide details)
• No action will be taken in Canada (provide rationale)
• Action(s) have not yet been determined

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