On January 13th 2021, as a consequence of the new PMPRB coming-into-force date, PMPRB has invited stakeholders to comment on two proposed amendments to the New Guidelines. The two amendments pertain to (A) the Definition of Gap Medicines and (B) Compliance Timelines with Maximum List Price (MLP). The two amendments are summarized below.
| Change |
January 1, 2021 Guidelines (current) | July 1, 2021 Proposed Guidelines (proposed) |
| Definition of Gap Medicines |
35. Gap medicines are medicines for which a DIN was assigned on or after August 21, 2019 and first sold in Canada prior to January 1, 2021 |
35. Gap medicines are medicines for which a DIN was assigned on or after August 21, 2019 and first sold in Canada prior to July 1, 2021 |
| Compliance Timelines with MLP |
76. Patentees must comply with the MLP within one reporting period of the MLP being set for Line Extension medicines and within two reporting periods (Dec. 2021) for Grandfathered or Gap medicines. |
76. Patentees must comply with
the MLP within one
reporting period (Dec. 2021) of the MLP being set for Line Extension medicines and for Grandfathered or Gap medicines. |
The PMPRB has requested stakeholders to provide their comments to the PMPRB Consultations inbox by February 15, 2021.
For inquiries on how PDCI can help with navigating your pricing needs,
please contact Kimberly Robinson, Director, Pricing and MarketAccess.