New interesting decisions from ENLI
In connection with the publication of ENLI's newsletter on 20 March 2023, a number of interesting decisions have been published. These concern, among other things: The boundary between information material and advertising, clarification of new practice on statements on environmental and climate issues in relation to the concept of professionalism, invitations to training events should be addressed to management, distribution of donated equipment to patients and sponsorship of podcast.
Article - 22.03.2023
New judgment from the Court of Justice of the European Union on borderline products
In its decision of 2 March 2023, the Court of Justice of the European Union (“the CJEU”) has considered the borderlines between A) medicinal products and food for special medical purposes as well as B) food for special medical purposes and food supplements.
Article - 09.03.2023
The deadline for the certification of certain medical devices extended
Manufacturers of medical devices can now for a while breathe a sigh of relief. The European Parliament have finally adopted a proposal for extending the certification deadlines as stipulated in the Medical Device Regulation ("the MDR").
Article - 20.02.2023
Easier for companies to submit their products for evaluation by the Danish Health Technology Council
Companies are no longer required to meet the cost neutrality requirement when submitting their medical devices and health technologies for evaluation by the Danish Health Technology Council.
Article - 16.02.2023
Increased competition from biosimilar medicines
Biosimilars can now be introduced without an assessment from the Danish Medicines Council.
Article - 13.02.2023
All applications for authorisations to run a clinical trial must as of 31 January 2023 be submitted via the EU CTIS
On 31 January 2023, it became compulsory to submit applications for new clinical trials through the CTIS EU portal, and this means that the 2022 Clinical Trials Regulation is now fully implemented.
Article - 03.02.2023
New EU judgment on the classification of borderline products
Sometimes it can be very difficult to classify products. A new ruling from the European Court of Justice on 19 January 2023 has brought more clarity to this area.
Article - 25.01.2023
ENLI expands the concept of professionalism
Environmental and climate change presentations can be included in future professional events organised by pharmaceutical companies
Article - 11.01.2023