The Danish Medicines Council publishes new guidelines for alternative contract models
In collaboration with Amgros and Lif, the Danish Medicines Council has prepared a new guideline describing how alternative contract models can be included in applications to the Danish Medicines Council.
Article - 28.11.2023
New practice on naming medicines
The Danish Medicines Agency has updated its practice on the naming of medicines.
Article - 02.11.2023
Proposals for new Pharmaceutical Legislation
New proposals for amendments to the Medicines Act, the health Act and the Committee Act have been presented.
Article - 23.10.2023
The European Court of Justice delivers a new judgement on wholesale distribution of medicines
The European Court of Justice has ruled on (i) the extent to which a wholesale distributor can acquire medicinal products from persons who are only authorised to supply medicinal products to consumers, (ii) the qualifications that the wholesalers staff must have, and (iii) the circumstances that must be taken into consideration when revoking a wholesalers distribution authorisation.
Article - 29.09.2023
New addition to Plesner's IP team
We are happy to announce that Kim Wagner is now part of Plesner's IP team as of 1 September 2023.
News - 01.09.2023
New suggestions for improving clinical trials during public health emergencies
In June, the European Medicines Agency's Emergency Task Force (ETF) and the European Commission held a workshop on clinical trials in light of the experiences gathered from the COVID-19-pandemic and the recent outbreak of mpox. The workshop resulted in a number of suggestions to improve large-scale, multinational clinical trials within the EU during public health emergencies.
Article - 08.08.2023
Help is at hand for manufacturers of medical devices: New “Manufacturer's Declaration” form
MedTech Europe has prepared a form (Manufacturer's Declaration”) that manufacturers can use in order to comply with the transitional provisions in the MD and IVD Regulations and also comply with the conditions that apply so that manufacturers can continue to place medical devices on the market.
Article - 07.07.2023
Pharmacies to relieve other parts of the healthcare system to a greater extent
A government-appointed working group has identified a number of areas where the pharmacies' competencies can be further utilized. The working group's recommendations will help relieve the burden on other parts of the healthcare system, increase patient safety and improve accessibility.
Article - 04.07.2023