Réglementaire - Sciences de la Vie

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• België : nieuwe gezondheidswet

  Article

  Envoyé: 26 November 2018

  Een nieuwe wet van 30 oktober 2018 houdende diverse bepalingen inzake gezondheid is gepubliceerd in het Belgisch Staatsblad op 15 november (de “Wet”).

• Belgique: nouvelle loi santé

  Article

  Envoyé: 26 November 2018

  Une nouvelle loi du 30 octobre 2018 portant des dispositions diverses en matière de santé, a été publiée le 15 novembre dernier au Moniteur Belge (la « Loi »).

• Parallelimporte von Medizinprodukten mit eigener Pharmazentralnummer des Importeurs - Problemaufriss zur Markenlizenzgestaltung nach der „Debrisoft“ Entscheidung des EuGH

  Article

  Envoyé: 26 November 2018

  Parallelimporte sind und bleiben ein Dauerbrenner. Namentlich für Medizinproduktehersteller dürfte eine jüngste Entscheidung des OLG Frankfurt am Main von Interesse sein, das die markenrechtlichen Möglichkeiten, gegen Parallelimporte vorzugehen, weiter eingeschränkt hat. Konkret ging es um Parallelimporte mit eigener PZN. In Zukunft ist daher vertraglichen Gestaltungen deutlich mehr Aufmerksamkeit zu widmen, sollen unerwünschte Parallelimporte möglichst weitgehend verhindert werden.

• Geographical limitation of insurance cover in liability insurance - a new insurance dimension of the PIP silicone breast implants scandal

  Article

  Envoyé: 20 November 2018

  This article discusses the request for a preliminary ruling under Article 267 TFEU of the Higher Regional Court of Frankfurt am Main referring the question whether the liability of the French insurer Allianz France towards a German appellant for defective silicone breast implants is dependent on the interpretation of the prohibition of anti-discrimination (Article 18 TFEU).

• EC Manual on Borderline & Classification - New interpretative rules for digital health technologies, trial hip prosthesis, anti-allergy mattresses and lubricants

  Article

  Envoyé: 19 November 2018

  On 30 October 2018, the European Commission (EC) published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (version 1.20) (the Manual). This is the second time the EC updates the Manual this year, after the last revision took place in April 2018 (version 1.19).

• Warner-Lambert feels the pain

  Article

  Envoyé: 16 November 2018

  Supreme Court rejects Warner-Lambert’s appeal and finds in favour of Actavis and Mylan in long-running pregabalin patent dispute.

• UK Government's policy paper on the digitalisation of health and care

  Article

  Envoyé: 31 October 2018

  On 17 October 2018, the UK Department of Health and Social Care (DHSC) published a policy paper entitled “The Future of Healthcare: Our vision for digital, data and technology in health and care” (the Policy Paper).

• Genomics: Transforming the life experience of humanity

  Article

  Envoyé: 17 October 2018

  We recently held a Simmons & Simmons Healthcare Hub dinner discussing the ground-breaking genomics work that is currently taking place in the UK and the potential for the mapping of genomes to transform our everyday healthcare.

• UK Government publishes draft Code of Conduct for data-driven healthcare technology

  Article

  Envoyé: 18 September 2018

  Issues to consider in a new Code of Conduct for data-driven healthcare technology providers issued by the Department of Health and Social Care.

• GDPR and Blockchain

  Article

  Envoyé: 13 September 2018

  Are Blockchain and GDPR compatible? Some issues to consider.

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