21
Sep 23
Whistleblowing Decree: Key points for the pharmaceutical sector
Large multinational companies are being called to assess the compatibility of existing reporting channels with the requirements of the new regulation published on March 15, 2023 on the Official Journal of the Italian Republic, implementing the EU Directive 2019/1937 on whistleblowing.
21
Sep 23
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have been included in the relevant list of the Consolidated Text on drug substances
18
Sep 23
The new Public Procurement Code: New items, application, and transitional regime
This article is the first in the "Public Procurement Corner" series, providing updates on the new public procurement code with a focus on supplies to NHS bodies.
Thanks to Antonino Iago Gentile for collaborating on this article
15
Sep 23
AI and machine learning in the medicine lifecycle: EMA publishes first draft of reflection paper
The first draft of EMA’s “Reflection paper” contains the authority’s latest considerations on the application of AI and machine learning methods in each phase of the medicinal product lifecycle.
14
Sep 23
Drug advertising: New rules on advertising for over-the-counter and non-prescription medicines (OTC and SOP)
The Italian Ministry of Health updated the guidelines regulating the use of media to publish advertising messages regarding OTC and SOP: a good step in terms of streamlining and simplification of the applicable regulatory framework.
Thanks to Denise Moretti for collaborating on this article
14
Sep 23
The AI Act: What will the impact be on the medical device industry?
The European Parliament approved the “AI Act” (June 14, 2023), a proposal for a regulation providing a uniform legal framework for the use of artificial intelligence in the EU.
