Prepare to submit an application under Canada's Access to Medicines Regime

Canada's Access to Medicines Regime requires that the following steps be completed prior to the submission by a pharmaceutical company of an application to the Canadian Commissioner of Patents for a compulsory licence. Where more detailed information is available, links to that information are provided. These steps may be completed in the order that is most efficient for the country and company involved.

The following steps must be taken and information regarding them provided to the Canadian Intellectual Property Office to meet the requirements of the Patent Act:

• The company must have a supply agreement with an eligible country for the sale to that country of an eligible product. A copy of this agreement must also be provided to the Commissioner of Patents and the patent holder within 15 days of the day the agreement was signed or the day the compulsory licence is granted, whichever is later.
• The importing country must notify either the World Trade Organization or the Government of Canada and provide the required information, which varies depending on the classification of the country.
• The company must perform a Canadian patent search and, if a patent exists, identify the patent holder or holders.
• At least 30 days before submitting the application, the company must try to obtain from the patent holder a voluntary licence to make and export the patented product.

The following steps must be taken with Health Canada's Therapeutic Products Directorate to meet the requirements of the Food and Drugs Act and its associated Regulations:

• Before the product is manufactured in quantities for export, the company must have it reviewed by Health Canada. The company does not have to complete the application for a compulsory licence before submitting the product to Health Canada for regulatory review.
• The company must provide Health Canada with information to establish that the product incorporates anti-diversionary measures. This includes a description of the product's distinguishing features (colour, marking and labelling), as required by the Food and Drug Regulations.

For an illustration of the preparation process, see the process map for preparing to submit an application. Once preparations for submitting an application have been completed, the company should proceed to Submitting an Application.