(1)

In accordance with Article 111b(1) of Directive 2001/83/EC, a third country may request the Commission to assess whether that country’s regulatory framework applicable to active substances exported to the Union, and the respective control and enforcement activities, ensure a level of protection of public health equivalent to that of the Union in order to be included in a list of third countries ensuring an equivalent level of protection of public health.

(2)

Canada requested, by letter dated 1 October 2018, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC.

(3)

The Commission has assessed the request by carrying on a review of the relevant documentation and an on-site review of Canada’s regulatory system and an observed inspection and taking due account of the action plan proposed on 23 September 2022, by the Canadian competent authority, Health Canada/Santé Canada.

(4)

The Commission has also assessed the regulations to extend Canada’s drug establishment licensing framework and Good Manufacturing Practice requirements to establishments that conduct regulated activities with active substances intended solely for export (2), which are to enter into force on 8 December 2022.

(5)

Based on that equivalence assessment, the Commission concluded that the requirements of Article 111(b) of Directive 2001/83/EC were fulfilled.

(6)

Commission Implementing Decision 2012/715/EU (3) should be amended accordingly.