Notification Requirements for Schedule 4, WTO and Non-WTO Member Countries
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
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
For a graphic illustration of the notification process, see the process map for Schedule 4 countries.
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