Notifying Health Canada of Foreign Actions in respect of a Serious Risk of Injury to Human Health

Email address (required)
This address will receive a record of your submitted form

Canadian 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)

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

Dossier ID of relevant Canadian product(s)

DIN(s) of relevant Canadian product(s)

Batch/Lot Number(s) of relevant Canadian product(s) (if applicable and if known within the 72 hours)

Expiration date of relevant Canadian product(s) (if applicable and if known within the 72 hours)
(YYYY-MM-DD)

Action(s) taken in foreign jurisdiction in respect of serious risks to human health, that trigger mandatory notification (see section 2.1, Notifying Health Canada of Foreign Actions - Guidance Document for Industry) (required)

risk communication

label change

recall

reassessment of product authorization

suspension or revocation of site license

suspension or revocation of market authorization

Details of action(s) taken in the foreign country:

warning

new contraindication

change to risk mitigation or vigilance plan

statement of non-compliance

other

Link to online information about the action

A brief description of the issue that gave rise to the foreign action, including when it occurred (required)

Type of issue that triggered the foreign action

GMP/manufacturing site
product quality/recall

Name of foreign manufacturer or authorization holder (required)
(200 characters)

Foreign jurisdiction(s) where action(s) taken (required)
pick one or more

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

How is this issue relevant to Canada? (required)

safety issue with same or similar (for biologics) medicinal ingredient(s) or molecule(s)

related site

affected product distributed in Canada

other:

A brief summary list of follow up actions already taken (if there have been any) by the Canadian MAH

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Notifying Health Canada of Foreign Actions in respect of a Serious Risk of Injury to Human Health

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