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.
11
Jun 24
Online medicine sales and the processing of purchase data: The Court of Justice of the European Union rules
Data related to purchasing non-prescription medicine sold online by an authorized pharmacy should not be considered health-related data under the GDPR.
4
Apr 24
Online sale of medicines without a prescription: The Court of Justice of the European Union approves intermediary sites
The Court of Justice of the European Union intervened on a major issue for the online medicine sales industry, paving the way for the entry of intermediary platforms.
19
Jan 24
Recent legislative news in the life sciences sector under the Budget Law
The so-called “Budget Law” for 2024 wields significant impact on the life sciences sector, and allocates to the healthcare sector EUR 3 billion for 2024, EUR 4 billion for 2025, and EUR 4.2 billion for 2026.
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new digital channels
5
Oct 22
Observational studies: From the November 30, 2021 Decree to the new document of the National Coordination Center for Ethics Committees
Pharmacological observational studies concern drugs prescribed according to an authorized therapeutic indication and based on normal clinical practice.
