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
The pharmaceutical industry's use of digital media in advertising
The Danish Ethical Committee for the Pharmaceutical Industry (ENLI) has published a revised guidance on the use of digital media in advertising. The guidance includes general information about digital media and explains specific concepts and rules of jurisdiction governing the area. The guide also includes a reference guide, Q&A and a number of annexes.
Article - 01.12.2022
The Court of Justice of the European Union upholds practices regarding parallel import of medicinal products
In this judgment of general public importance, the The Court of Justice of the European Union ("CJEU") established on 17 November 2022 that the Falsified Medicines Directive does not change CJEU practices on the parallel import of medicinal products. The CJEU has therefore overruled the Danish Medicines Agency and its guidelines requiring, as a general rule, that parallel-imported medicinal products must be repackaged into new outer packaging. Plesner assisted H. Lundbeck A/S in this case.
Highlight - 30.11.2022
Public consultation on the guidelines on the advertising of medicinal products
The Danish Medicines Agency has sent two new draft guidelines on the advertising of medicinal products for respectively humans and animals out for consultation with a deadline of 1 March 2022. The drafts contain specifications within several areas, including in relation to the use of SoMe and vaccination campaigns.
Article - 16.02.2022
Medical device news
The European Commission’s extended transition period regarding in vitro diagnostic medical devices has come into force, and new guidelines have been issued regarding clinical evidence for in vitro diagnostic medical devices and regarding electronic instructions for use.
Article - 14.02.2022
News regarding the Danish Medicines Council - conditional recommendations to be used as of 2022
The board of the Danish Regions has decided that as of 1 January 2022, and for a limited period, the Danish Medicines Council can issue conditional recommendations regarding medicinal products.
Article - 03.11.2021
Medical device news
The European Commission launches modules 2 and 3 of EUDAMED, and the Medical Device Coordination Group has published two new guidance documents.
Article - 12.10.2021