You are here: Home Legal Topics Life Sciences Regulatory
Careful forward planning is required by pharmaceutical companies conducting clinical trials ahead of the implementation of the General Data Protection Regulation in May 2018.
Submitted: 23 April 2019
The proposed European legislation to amend the SPC Regulation and introduce a manufacturing waiver (for export and stockpiling) has now been approved by the European Parliament on first reading.
Event date: 08 May 2019
Almost two years have passed since the Medical Devices Regulation (EU) 2017/745 (MDR) entered into force. This leaves only one year for Healthcare & Life Sciences companies to ensure operational and legal readiness and implement this significant piece of legislation.
Submitted: 16 January 2019
The Simmons & Simmons Healthcare Hub dinner on 29 November 2018 discussed the challenges associated with the regulation of NHS-funded services and what the wider healthcare sector can learn from them.
Submitted: 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”).
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 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.
Submitted: 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).
Submitted: 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).
Submitted: 16 November 2018
Supreme Court rejects Warner-Lambert’s appeal and finds in favour of Actavis and Mylan in long-running pregabalin patent dispute.
Submitted: 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).
Episode 429: Collusive strategy triggers damages action
View all video podcasts
Our new research explores the deal structures that organisations will adopt in 2019, as well as the eight key barriers that will stop many realising their goals.
Access the latest findings here.
Brussels 8 May 2019
View all events
View all training materials
The Unified Patent Court is coming and will eventually have exclusive jurisdiction over all European Patents and new European Patents with Unitary Effect.
Our microsite gives guidance on how the new court system will work and key issues to consider.
Visit the microsite
© Simmons & Simmons LLP 2019. All rights reserved. Registered in England & Wales Registered Number OC352713
elexica Limited, CityPoint, One Ropemaker Street, London EC2Y 9SS