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EHDS Regulation in the Pharmaceutical Sector
The New EHDS Regulation in the Pharmaceutical Sector: Challenges and Opportunities The EHDS Regulation in the Pharmaceutical Sector represents a historic milestone in European legislation, following its publication in March 2025 (Regulation EU 2025/327). Rather than...
EUROPEAN HEALTH DATA SPACE
On April 24, 2024, the European Parliament approved the proposal for a regulation establishing the creation of the European Health Data Space. This innovative initiative aims to improve access to personal health data across the European Union, safeguarding the...
REFORM OF EUROPEAN PHARMACEUTICAL LEGISLATION
On April 10, 2024, the proposal for the reform of EU pharmaceutical legislation was approved, for a new European directive and regulation, to promote innovation, guarantee access to medicines and more affordable prices, while supporting research, namely new...
IMPLEMENTATION OF THE MEDICAL DEVICE REGULATION
On April 5, 2024, Decree-Law no. 29/2024, with effect from July 4, 2024, defining the provisions applicable to economic operators, healthcare institutions that manufacture and use devices in their respective facilities, as well as the rules applicable to use and...
