Notification for WTO and non-WTO member countries under Canada's Access to Medicines Regime

Before importing a drug or medical device through Canada's Access to Medicines Regime, countries that are members of the World Trade Organization (WTO) and developing countries that are not members of the WTO, as identified on Schedule 4 to Canada's Patent Act, are required to notify

• the WTO, if they are a member of the WTO (model notification letter); or
• the Government of Canada, if they are not a member of the WTO (model notification letter).

For instructions on how to provide notice, see Notifying the World Trade Organization or Notifying the Government of Canada.

Countries must disclose the following information to the appropriate authority when planning to use the Regime:

• The name and quantity of the drug or medical device needed;
• A declaration that the importing country does not have the capacity to manufacture the needed product;
• A declaration that they are faced with a public health emergency or other circumstance of extreme urgency; and
• A declaration that the product is not patented in the importing country; or
• If the product is patented in the importing country, a declaration that the country will or has issued a compulsory licence authorizing the importation of the product.

Developing countries that are not members of the WTO are also required to declare that

• they will adopt measures to prevent diversion of the products to unintended markets; and
• the product will not be used for commercial purposes.

For a graphic illustration of the notification process, see the process map for Schedule 4 countries.