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Smart & Biggar | 25 Nov 2020

Few significant changes made in final PMPRB guidelines

The Patented Medicine Prices Review Board recently published the final version of its guidelines which operationalise the amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021. This article provides a brief summary of the final framework for the price review process and highlights changes relative to the June 2020 draft guidelines.
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Smart & Biggar | Canada | 23 Nov 2020

Few significant changes made in final PMPRB guidelines

The Patented Medicine Prices Review Board recently published the final version of its guidelines which operationalise the amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021. This article provides a brief summary of the final framework for the price review process and highlights changes relative to the June 2020 draft guidelines.
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Smart & Biggar | 9 Nov 2020

Final PMPRB guidelines released

The Patented Medicine Prices Review Board (PMPRB) recently released the final guidelines operationalising the amended Patented Medicines Regulations. The guidelines describe the price review methodology that will apply to medicines from 1 January 2021, when the amended regulations come into force. The PMPRB has also released its October 2020 Newsletter, which includes an overview of final......
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Smart & Biggar | Canada | 4 Nov 2020

Final PMPRB guidelines released

The Patented Medicine Prices Review Board (PMPRB) recently released the final guidelines operationalising the amended Patented Medicines Regulations. The guidelines describe the price review methodology that will apply to medicines from 1 January 2021, when the amended regulations come into force. The PMPRB has also released its October 2020 Newsletter, which includes an overview of final......
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Smart & Biggar | Canada | 4 Nov 2020

New interim order for COVID-19 drugs has wide-reaching impact

The minister of health recently approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Once approved by the governor in council, the interim order will be valid for only one year from the day on which it was signed by the minister, and product authorisations issued under the interim order will be valid only while the interim order......
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Smart & Biggar | 15 Jun 2020

Amended Patented Medicines Regulations will come into force on 1 January 2021

The Patented Medicine Prices Review Board recently announced that the amended Patented Medicines Regulations will now come into force on 1 January 2021. Further, a revised set of draft guidelines will be published during the week of 15 June 2020, followed by a 30-day consultation period.
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Smart & Biggar | Canada | 3 Jun 2020

Amended Patented Medicines Regulations will come into force on 1 January 2021

The Patented Medicine Prices Review Board recently announced that the amended Patented Medicines Regulations will now come into force on 1 January 2021. Further, a revised set of draft guidelines will be published during the week of 15 June 2020, followed by a 30-day consultation period.
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Smart & Biggar | 3 Feb 2020

Life sciences intellectual property: 2019 highlights

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including significant amendments to the Patented Medicines Regulations, a number of biosimilars developments relating to approvals, pending submissions and naming and the second anniversaries of the certificate of supplementary protection regime and the Patented Medicines......
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Smart & Biggar | Canada | 29 Jan 2020

Life sciences intellectual property: 2019 highlights

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including significant amendments to the Patented Medicines Regulations, a number of biosimilars developments relating to approvals, pending submissions and naming and the second anniversaries of the certificate of supplementary protection regime and the Patented Medicines......
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Smart & Biggar | Canada | 11 Dec 2019

PMPRB releases draft guidelines operationalising amended Patented Medicines Regulations

The Patented Medicines Prices Review Board recently released new draft guidelines for consultation and a backgrounder. The new guidelines aim to operationalise the amended Patented Medicines Regulations, which come into force on 1 July 2020, and provide a number of circumstances in which categories or price ceilings may be reassessed.
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