In its proposals to revise the general pharmaceutical legislation (GPL) published this week, the European Union (EU) has recognised that the pharmaceutical product lifecycle can have negative impacts on the environment....more
The European Commission has published its long awaited and leaked proposals for a once-in-a-generation revision of the EU general pharmaceutical legislation (GPL)....more
Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more
4/26/2023
/ Algorithms ,
Anticompetitive Agreements ,
Artificial Intelligence ,
Connected Items ,
DATA Act ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Facilities ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Proposed Legislation
The Belgian Federal Agency for Medicines and Health Products (the FAMHP) has reviewed its procedure to remove or add patented therapeutic indications or dosage forms from the generic medicines' marketing authorisation (MA),...more
The European Commission has moved to the next phase in its evaluation of the current EU pharmaceutical legislation and the potential for its reform by opening a 12 week online public consultation....more
As next generation Covid-19 vaccine developers consider whether ethical and practical clinical efficacy trials can be conducted, they might consider whether vaccine efficacy can instead be inferred. We consider the...more
On Tuesday, 26 January 2021, Allen&Overy (Belgium) LLP hosted a webinar on the key developments in parallel trade of pharmaceuticals in 2020. In this blog post, we discuss a few key topics and questions raised by the...more
On 23 June 2017, the Belgian “Sunshine Act” entered into force, requiring life sciences companies to disclose relationships with healthcare actors based in Belgium. Companies in both the pharmaceutical and medical devices...more