On July 12, 2018, Health Canada had published “Guidance on Notifying Health Canada of Foreign Actions – Guidance Document for Industry”. On November 20, 2018, Health Canada updated its Guidance, including with a link to an on-line reporting form: Notifying Health Canada of Foreign Actions - Guidance Document for Industry, updated November 20, 2018. This update comes after the foreign risk reporting requirement provisions of the Food and Drug Regulations (as previously reported) came into force in October 2018. We have updated our previously published chart to include this Guidance.
Related Publications & Articles
-
Agile licensing amendments registered
Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered.Read More -
2024 highlights in Canadian life sciences IP and regulatory law
In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law.Read More -
Health Canada proposes to amend the Food and Drug Regulations and Medical Devices Regulations to address shortages
On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article re...Read More