Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical devices entered into force following publication on EU's Official Journal
2
Feb 23
Transparency and responsibility regarding medical-scientific information on the web
On September 28, two international pharmaceutical industry associations, the IFPMA and the EFPIA, published a Joint Note for Guidance on social media and digital channels to guide the work of pharmaceutical companies that use the web to provide doctors and patients with information about their products and the illnesses they are intended to treat.
2
Feb 23
Register of Observational Studies: AIFA announces activation as of January 31, 2023
In a recent press release published on its website, the AIFA announced that as of January 31 the Register of Observational Studies (“RSO”) will be active and accessible through the AIFA online services portal — as is already the case for interventional pharmacological studies and the related OsSC portal.
2
Feb 23
The CJEU rules on the legality of a national law prohibiting medicinal product advertising to the general public that uses price to induce consumers to purchase
In the recent judgment of December 22, 2022 in Case C-530/20, the CJEU ruled that European law and in particular Directive 2001/83/EC are compatible with a national law that prohibits advertising even unidentified medicinal products if the advertising message encourages the purchase of the products by leveraging pricing, promotional offers, discounts, and combined sales with other products, medicinal or otherwise (including at discounted prices).
2
Feb 23
New decrees for the reorganization of ethics committees have been signed: The last fundamental steps for operation of the CTR in Italy
On January 30, the Ministry of Health finally signed four ministerial decrees that mark fundamental turning points in the construction of a regulatory framework for the European Clinical Trials Regulation (“CTR”) to become operations.
<!--:it-->Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization procedure and (iii) regulate the transitional period for evaluation activities<!--:-->
