Filing Requirements and Deadlines

Patentee and Medicine Information

Information Timing Patent Act Regulations Form
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

Information Timing Patent Act Regulations Form

Price & sales data for the medicine sold to each class of customer by province/territory in Canada

Publicly available ex-factory price sold to each class of customer in Germany, France, Italy, Sweden, Switzerland, United Kingdom and United States

When a drug is first offered for sale in Canada, no later than thirty (30) days afterthe 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)(e)

4(2) & (3)

4(1)(f)

4(1)(g)

2

Revenue and R&D Expenditures

Information Timing Patent Act Regulations Form
Revenues from sales and expenditures on R&D On or before March 1 of each year 88(1) 88(2) 5, 6 3
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