Filtres
France renews its simplified anti-gift conventions – what life sciences companies operating in France need to know
France enforces one of Europe's strictest anti-gift regimes, broadly prohibiting any benefit to healthcare professionals, in particular. Within this framework, simplified conventions offer a practical derogation — allowing companies to bundle hospitality declarations into a single filing. These conventions have just been renewed for another two years, with notable developments: COMIDENT (dental sector) joins as a signatory and a new two-month deadline applies for participant list submissions for certain types of convention.
5 de 9 Publications
Case law – VfGH on the eImpfpass and central vaccination register
The Austrian Constitutional Court rejected challenges to the eImpfpass and central vaccination register on procedural grounds. The decision leaves the register in place, but highlights the role of data protection remedies in digital health infrastructure.
6 de 9 Publications
EHDS implementation: preparing for health data access and reuse
EHDS implementation has begun. For life sciences companies, the key issue is how controlled access to health data, secondary use, AI training and data protection governance will work in practice – and what should be prepared before 2029.
2 de 9 Publications
Advising Nuclera on its extended Series C funding to US$87 million
Guidance to manufacturers withdrawing a medical device from the EU market
Medical product availability and healthcare safety are becoming increasingly important talking points. This is also reflected in the EU regulations on medical devices. Although the provisions may seem straightforward their vagueness may give rise to significant doubts as to which situations they will apply to in practice.
4 de 5 Publications
EU and medicines supply issues (part one): Current measures
Marketing Authorisation Holders (MAHs) in the EU are legally required to report medicine supply shortages to the European Medicines Agency and national authorities. This article explores the central role of Marketing Authorisation Holders (MAHs) in identifying and managing medicine supply shortages in the EU as well as the role of EMA committees and working groups in coordinating responses and maintaining the Critical Medicines List to safeguard public health.
2 de 5 Publications
EU and medicines supply issues (part two): Proposals for future measures
In part two of our article on EU and medicine supply issues we explore the key proposals outlined in pharmaceutical reform and their impact on marketing authorisation holders across the region.
3 de 5 Publications
Comparison of national measures to protect the supply of medicines and medical devices
Our international team has developed a practical guide that allows users to navigate different European jurisdictions, identifying medicines subject to supply restrictions, and understand manufacturers' obligations during shortages or product withdrawals.
5 de 5 Publications
Starting a telemedicine business today - how do I proceed?
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Filtres
France renews its simplified anti-gift conventions – what life sciences companies operating in France need to know
France enforces one of Europe's strictest anti-gift regimes, broadly prohibiting any benefit to healthcare professionals, in particular. Within this framework, simplified conventions offer a practical derogation — allowing companies to bundle hospitality declarations into a single filing. These conventions have just been renewed for another two years, with notable developments: COMIDENT (dental sector) joins as a signatory and a new two-month deadline applies for participant list submissions for certain types of convention.
5 de 9 Publications
Case law – VfGH on the eImpfpass and central vaccination register
The Austrian Constitutional Court rejected challenges to the eImpfpass and central vaccination register on procedural grounds. The decision leaves the register in place, but highlights the role of data protection remedies in digital health infrastructure.
6 de 9 Publications
EHDS implementation: preparing for health data access and reuse
EHDS implementation has begun. For life sciences companies, the key issue is how controlled access to health data, secondary use, AI training and data protection governance will work in practice – and what should be prepared before 2029.
2 de 9 Publications
Advising Nuclera on its extended Series C funding to US$87 million
Guidance to manufacturers withdrawing a medical device from the EU market
Medical product availability and healthcare safety are becoming increasingly important talking points. This is also reflected in the EU regulations on medical devices. Although the provisions may seem straightforward their vagueness may give rise to significant doubts as to which situations they will apply to in practice.
4 de 5 Publications
EU and medicines supply issues (part one): Current measures
Marketing Authorisation Holders (MAHs) in the EU are legally required to report medicine supply shortages to the European Medicines Agency and national authorities. This article explores the central role of Marketing Authorisation Holders (MAHs) in identifying and managing medicine supply shortages in the EU as well as the role of EMA committees and working groups in coordinating responses and maintaining the Critical Medicines List to safeguard public health.
2 de 5 Publications
EU and medicines supply issues (part two): Proposals for future measures
In part two of our article on EU and medicine supply issues we explore the key proposals outlined in pharmaceutical reform and their impact on marketing authorisation holders across the region.
3 de 5 Publications
Comparison of national measures to protect the supply of medicines and medical devices
Our international team has developed a practical guide that allows users to navigate different European jurisdictions, identifying medicines subject to supply restrictions, and understand manufacturers' obligations during shortages or product withdrawals.
5 de 5 Publications
Starting a telemedicine business today - how do I proceed?