News

Health apps insight

New rules on health research and health data research projects

New ENLI guide on information material and medical devices

EMA updates user guide for SMEs in the pharmaceutical sector

Good news for sponsors of combination studies involving both drugs and IVD medical devices

Help is at hand: New guidelines for medical device software

The Danish Medicines Council publishes new guidelines for alternative contract models

New practice on naming medicines

Proposals for new Pharmaceutical Legislation

The European Court of Justice delivers a new judgement on wholesale distribution of medicines

New addition to Plesner's IP team

New suggestions for improving clinical trials during public health emergencies

Help is at hand for manufacturers of medical devices: New “Manufacturer's Declaration” form

Pharmacies to relieve other parts of the healthcare system to a greater extent

New classification mechanism for borderline products

ENLI makes several clarifications in the guidance to the Promotion Code

New pharmaceutical legislation focusing on access to medicine and sustainability

Extension of price cap agreements on hospitals and pharmacy-restricted medicinal products

From 22 June 2023, the Medical Device Regulation (MDR) will also apply to certain types of devices without a medical purpose

New interesting decisions from ENLI