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Healthcare & Life Sciences

06 February 2019
Kirian Claeyé Anti-tampering devices – fading boundaries of parallel trade?

Belgium - ALTIUS

A legislative package aimed at fighting falsified medicines will enter into force in the European Union in early 2019. This EU legal framework was transposed into Belgian law through the Medicines Act and the Royal Decree concerning Medicines for Human and Veterinary Use. As a result, pharmaceutical companies will be required to affix a so-called 'anti-tampering device' on all prescription medicinal products to allow verification of whether the packaging has been tampered with.

Authors: Kirian Claeyé, Laura Traest
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Nancy Pei Life sciences intellectual property: 2018 highlights

Canada - Smart & Biggar/Fetherstonhaugh

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including a consultation on the different approaches to the naming of biological drugs. Among other developments, four biosimilars were approved, the Canadian Agency for Drugs and Technologies in Health announced revisions to its biosimilar and administrative review process and significant proposed amendments to the Patent Rules were released.

Author: Nancy Pei
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Scott D Stein Flexing its Granston muscle: DOJ seeks dismissal of patient support services in False Claims Act litigation

USA - Sidley Austin LLP

The Department of Justice (DOJ) recently stepped in to seek the dismissal of high-profile False Claims Act litigation being pursued by relators after the government initially declined to intervene. The DOJ's recent action, which pertains to approximately a dozen lawsuits involving pharmaceutical manufacturers and third-party service providers, is further evidence that the Granston Memo, in which the DOJ articulated clearer standards for seeking dismissal of non-intervened cases, has real teeth.

Authors: Scott D Stein, Neil G Nandi
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Recent updates

Jaime L M Jones DOJ intervenes in Medicare Advantage False Claims Act suit against provider

USA - Sidley Austin LLP

Authors: Jaime L M Jones, Jennifer M Haney
Rainer Herzig Amendment to Act on the Medical Profession

Austria - Preslmayr Attorneys at Law

Author: Rainer Herzig
Katie Lee Health Canada publishes revisions to guidance document on notifying Health Canada of foreign actions

Canada - Smart & Biggar/Fetherstonhaugh

Author: Katie Lee
Willemijn van der Wel Small boost in battle against high prices for medicinal products

Netherlands - AKD NV

Author: Willemijn van der Wel
E Sevi Fırat Regulatory authority publishes announcement regarding medical device sales centres

Turkey - Fırat Izgi Attorney Partnership

Authors: E Sevi Fırat, Ata Umur Kalender
Lise Gran Supreme Court opines on limitations of GPs' freedom of conscience

Norway - Homble Olsby Advokatfirma AS

Authors: Lise Gran, Ole Kristian Olsby