Filing Requirements and Deadlines

Identity of medicine, patentee and patent(s)

Earliest of:

Seven (7) days after the date the first Notice of Compliance issued

Seven (7) days after the date the medicine is first offered for sale in Canada

80(1)(a)
80(2)(a)

3(1) 3(2)
3(3)

1

Updating information on identity of medicine/patentee

Within thirty (30) days after any modification of information

3(4)

1

Price and sales data for the medicine sold to province/territory in Canada

Publicly available ex-factory price sold in, France, Germany, Italy, Sweden, Switzerland, United Kingdom and the United States

When a drug is first offered for sale in Canada, no later than thirty (30) days after the first day of sales

On or before July 30 (January 1 to June 30 reporting period)

On or before January 30 (July 1 to December 31 reporting period)

80(1)(b) 80(2)(b)

4(1)
4(2)

2

Revenues from sales and expenditures on R&D

On or before March 1 of each year

88(1) 88(2)

5, 6

3