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

Food and Drug Regulations, C.01.050

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

Type of issue that triggered the foreign action

  • GMP/manufacturing site
  • product quality/recall
  • safety/toxicity/adverse reaction/unsafe use: human pharmaceutical
  • safety/toxicity/adverse reaction/unsafe use: human biologic
  • safety/toxicity/adverse reaction/unsafe use: veterinary

(200 characters)

pick one or more

How is this issue relevant to Canada? (required)

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