Update: The coming into force date of the amended Patented Medicines Regulations has been deferred, once again, until July 1, 2022, which as announced on April 14, 2022, will be released in a substantially amended form.
Further to our last update on the amendments to the Patented Medicines Regulations (see
here) and related Guidance (see
here), the Patented Medicine Prices Review Board (PMPRB) has today
announced
that:
- The coming into force date of the amended Patented Medicines Regulations will now be January 1, 2021; and
- A revised set of draft Guidelines will be published the week of June 15, 2020 followed by a 30-day consultation period.
The most immediate and practical impact of this change is that reporting requirements due by July 30, 2020 of sales and pricing information for the period from January 1, 2020 to June 30, 2020 will clearly be governed by the current Regulations (see our later article here).
Should you have any questions on the foregoing, please do not hesitate to contact a member of the
Life Sciences Regulatory & Compliance
Group.