Guidance on Notifying Health Canada of Foreign Actions

Guidance on Notifying Health Canada of Foreign Actions

Published on August 27, 2018

Author: Pinky Mazumder 

The guidance document on Notifying Health Canada of Foreign Actions (the “Guidance Document”) is intended to help Market Authorization Holders (“MAH”) of a Drug Identification Number (“DIN”) or Notice of Compliance (“NOC”) to maintain compliance. Per the Food and Drug Regulations, it is a requirement for a MAH to inform Health Canada of foreign regulatory actions relevant to its products marketed in Canada. The foreign notification requirement allows Health Canada to improve its collection and assessment of safety information relevant to the Canadian drug product. When drugs are marketed in other countries before they are marketed in Canada, reporting the foreign regulatory actions for such products allows Health Canada to have a thorough collection of safety signals to better mitigate potential risks to Canadians.

The requirement to notify Health Canada of foreign regulatory actions applies to products assigned a DIN or NOC for the following categories of drugs:

·         Prescription drugs;

·         Prescription drugs by part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations; or

·         Non-prescription drugs administered only under the supervision of a practitioner.

As set out in the Guidance, the reporting requirement does not apply to products currently undergoing review by Health Canada. The reporting requirement also applies to veterinary drugs if a foreign regulatory action involves a risk to human health. Some examples of foreign regulatory actions for which the MAH is required to notify to Health Canada, include:

·         Serious risks involving a new contraindication that is publically communicated by the foreign regulatory authority to its jurisdiction;

·         Recalls due to a serious risk under the foreign regulatory jurisdiction;

·         Labelling changes publically communicated by the foreign regulatory authority or requested by the foreign regulatory authority (labelling changes could include new dosages, warning statements, and improved clarity to mitigate incorrect use).

Information subject to the reporting requirements be reported to the Minster through an online Health Canada form within 72 hrs after becoming aware of the foreign regulatory action.

For more information on notifying Health Canada of foreign regulatory actions and for examples of the foreign regulatory actions to be reported, please see the Health Canada guidance document cited in the reference section below.

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Reference:

Notifying Health Canada of Foreign Actions – Guidance Document for Industry

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/foreign-actions-profile/guidance-document.html#1.1

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