New e-book about the requirements for CE-certification under the IVDR
MedTech Europe has published a new e-book about the clinical evidence requirements that must be fulfilled to obtain CE certification under the In Vitro Diagnostic Medical Regulation (2017/746) ("IVDR"). The e-book is designed to help manufacturers to better understand and comply with the requirements set out in the IVDR.
Article - 10.06.2020
Coronavirus: new corona agency and joint European regulatory guidance for marketing authorisation holders during the COVID-19 pandemic
The Government is establishing a new corona agency to ensure the availability personal protective equipment and increased test capacity.
Article - 18.05.2020
News from the Life Science sector - ENLI updates guides and QALY is postponed
ENLI's new guide - ENLI (the Ethical Committee for the Pharmaceutical Industry) has decided to allow the use of patients as speakers for a trial period of one year starting on 1 June 2020. Further, ENLI has updated its guides regarding financial support and pre-launch.
Article - 15.05.2020
The first pan-Scandinavian tender for delivery of medicinal products has been completed
In co-operation with its Norwegian counterpart, Amgros has now completed the first pan-Scandinavian tender for the delivery of medicinal products.
Article - 13.02.2020
The European Court of Justice dismisses general presumption of confidentiality for clinical and toxicological study reports
In the parallel cases C-175/18, PTC v EMA, and C-178/18, MSD v EMA, the European Court of Justice has considered the general question whether there is a general presumption of confidentiality for clinical and toxicological study reports submitted to the European Medicines Agency as part of an application for a marketing authorisation.
Article - 31.01.2020
Preliminary injunction against the veterinary drug Forceris
By a ruling of 3 January 2020, Bayer has obtained a preliminary injunction from the Maritime and Commercial High Court against the sale, use and possession of Ceva's veterinary drug Forceris. Plesner represented Bayer in the trial.
Highlight - 24.01.2020
Revision of the ENLI's Codes of Conduct
ENLI has made amendments to its codes of conduct as a consequence of EFPIA's consolidation of its three codices (the EFPIA HCP Code, the EFPIA PO Code and the EFPIA Disclosure Code).
Article - 18.12.2019
The Danish Regions propose to establish a Treatment Council
The Danish Regions have proposed a new model for establishing a so-called Treatment Council which is to assess whether the price of treatments and health technology measure up to the effect for the patients. The model will now go out for consultation.
Article - 18.12.2019