Improving the quality of medicines

A Commission decision adopted today will contribute to improve the quality of medicines in the EU. It allows trusting on the quality of active substances produced in Canada. 

To guarantee their quality, active substances manufactured in third countries like Canada and intended for human medicines placed on the EU market, must be manufactured in an EU equivalent regulatory system including rules for good manufacturing practices (GMP).

Third countries can ask the Commission to assess whether their regulatory framework and the respective control and enforcement activities are ensuring a level of protection of public health equivalent to that of the Union, Health Canada/Santé Canada, a federal department of the Canadian Ministry of Health, requested in October 2018 to be assessed.

The review of the relevant documentation submitted by Health Canada/ Santé Canada was successful and after an onsite audit conducted by the Commission in 2022, the Commission implementing decision of today is confirming that the legislative framework of Canada applicable to active substance is capable to ensure a level of protection of public health equivalent to that of the Union.

Canada will join the list of third countries recognised so far:  Australia, Brazil, Israel, Japan, South Korea, Switzerland and the United States. 

For more information

• Importation of active substances - Listing of third countries