25
Feb
Procurement of biosimilar medicines in public tenders: Regulatory framework and recent caselaw
The procurement of biosimilars intended for the entities of the National Health Service, while generally regulated by the Public Procurement Code, is subject to special rules due to the unique characteristics of these products compared to chemically derived medicines.
25
Feb
Anti-counterfeiting of medicines: The new provisions of the Decree implementing delegated Regulation on falsified medicines
On February 6, 2025 the new Legislative Decree 10/2025 implementing the Delegated Regulation (EU) 2016/161 on the anti-counterfeiting of medicinal products was approved.
25
Feb
Supplementing rules to the Public Procurement Code: The new Decree and its impact on tenders and contracts
The new Legislative Decree 209/2024 introduces complementary and corrective provisions to the Italian Public Procurement Code with the aim of simplifying the current legislation and solving the problems that have arisen in the application of the new provisions of the Code, as also requested by the European Union.
24
Feb
Budget law 2025: News for the healthcare sector
Annual budget laws bring numerous changes that also affect the healthcare sector. Let's look at the main novelties.
24
Feb
AIFA stops all clinical trials that do not comply with the Clinical Trials Regulation on January 31, 2025
According to the EU Regulation on Clinical Trials (CTR), for the first 3 years from the application of the CTR, trials could be conducted in Europe according to the CTR or according to the previous legislation, depending on when the request for authorization to conduct the trial was submitted.
22
Nov 24
Medical research: Prior consultation with the Data Protection Authority is no longer required
Medical research is one of the areas most affected by rapid technological development and increased use of artificial intelligence (AI) systems.
