Post-July 1, 2022 Filing Requirements and Deadlines
| Information | Timing | Patent Act | Regulations | Form |
|---|---|---|---|---|
| Identity of medicine, rights holder 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/rights holder | Within thirty (30) days after any modification of information | 3(4) | 1 |
| Information | Timing | Patent Act | Regulations | Form |
|---|---|---|---|---|
|
Price and sales data for the medicine sold to province/territory in Canada Publicly available ex-factory price sold in Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden and United Kingdom |
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 |
| 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 |