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Healthcare & Life Sciences

25 November 2020
Urszula Wojtyra Federal Court orders minister of health to issue NOC to Fresenius Kabi for biosimilar

Canada - Smart & Biggar

Justice Manson of the Federal Court recently ordered the minister of health to issue a notice of compliance to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie's HUMIRA. The minister of health had completed its review of Fresenius Kabi's new drug submission for IDACIO; the only outstanding issue was whether Fresenius Kabi had addressed the patents listed on the Patent Register in respect of HUMIRA.

Author: Urszula Wojtyra
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Abigail Smith Few significant changes made in final PMPRB guidelines

Canada - Smart & Biggar

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.

Authors: Abigail Smith, Nancy Pei, Daphne Lainson
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Eduardo Buitrón de Vega Patuel Short-term health preparedness for COVID-19 outbreaks

European Union - Eversheds Sutherland (International) LLP

The European Union recently published a communication on the European Union's short-term health preparedness for COVID-19 outbreaks, which aims to reinforce the European Union's preparedness and create a coordinated response capacity to counter further outbreaks of COVID-19. This article highlights the main measures provided by the communication, including with regard to testing, contact tracing and medical countermeasures.

Authors: Eduardo Buitrón de Vega Patuel, Natalia Marín Villamiel, Tobias Maier
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Recent updates

Christopher Gotz Data protection and IT security requirements for digital health app under Social Security Code

Germany - Simmons & Simmons LLP

Authors: Christopher Gotz, Fabian Huber, Felix Hänel
Veleka Peeples-Dyer FDA's new guidance on emergency use authorisations for COVID-19 vaccines

USA - Baker McKenzie

Authors: Veleka Peeples-Dyer, Khelin N Aiken, Shira Sasson
Eduardo Buitrón de Vega Patuel Latest EU measures relating to COVID-19 pandemic – multicentre clinical trials

European Union - Eversheds Sutherland (International) LLP

Authors: Eduardo Buitrón de Vega Patuel, Natalia Marín Villamiel, Tobias Maier
Eduardo Nogueira Pinto Exceptional rules for products to prevent spread of COVID-19

Portugal - PLMJ - Sociedade de Advogados

Authors: Eduardo Nogueira Pinto, Eliana Bernardo, Rúben do Carmo Pereira
Eleanor Wilson Health Canada issues interim order respecting drug shortages relating to COVID-19

Canada - Smart & Biggar

Author: Eleanor Wilson
Joanne van Harmelen Battling COVID-19: mechanisms for access to antiviral products and diagnostics

South Africa - ENSafrica

Author: Joanne van Harmelen
Kirian Claeyé Can parallel importers rebrand generic medicines?

Belgium - ALTIUS

Authors: Kirian Claeyé, Laura Traest
Rainer Herzig Reimbursement for medicine not listed in Reimbursement Code?

Austria - Preslmayr Attorneys at Law

Author: Rainer Herzig