On 19 December 2022, the Recommendation Paper on Decentralized Elements in Clinical Trials was published on the website of the European Medicines Agency, with the aim to facilitate the conduct of decentralized clinical trials in the EU, while safeguarding the rights and well-being of participants and the robustness and reliability of the data collected.
On 23 December 2022, the Italian Medicines Agency (AIFA) published on its website an update concerning the procedures for submitting the Active Substance Master File, which is the document that the manufacturer of the active ingredient is required to submit to AIFA for the active substances contained in the medicine for which a marketing authorization has been applied for.
On 11 January 2023, Decree Law No. 4 on “Urgent provisions regarding the procedures for the repayment of the medical device expenditure ceiling overrun” was published in the Italian Official Gazette. Article 1 of the Decree extends to 30 April 2023 the deadline by which companies that supplied medical devices to NHS during the years 2015-2018 must pay the required payback amounts.
Industrial action is on the rise throughout Europe; in this webinar we looked at the differences and similarities in the industrial action process across France, Germany, Italy, Spain, the Netherlands, Poland and the UK, the potential legal remedies in each jurisdiction and the practical steps employers can take to keep the business running.
In brief This publication features the latest Employment developments in Italy. New laws and regulations Extension of the…
On 10 November 2022, the National Coordination Centre for Ethics Committees published the updated versions of the ‘Contract for the performance of clinical trials on medicines’, the ‘Contract for the performance of independent clinical trials on medicines’ and the ‘Contract for the performance of clinical investigations on medical devices that are not CE marked or CE marked but used outside their intended use’.
On 1 December 2022, Implementing Regulation EU 2022/2347 on the reclassification of groups of certain active medical devices without an intended medical purpose, as listed in Annex XVI to Regulation EU 2017/745, was published in the Official Journal of the EU.
On 11 November 2022, the Ministry of Ecological Transition answered the Confindustria’s question on whether the packaging of medicines for human use, medical devices and in-vitro diagnostic medical devices must comply with the environmental labelling requirements set forth in Article 219, Section 5, of Legislative Decree 152/2006, starting from 1 January 2023.
On 9 December 2022, the Italian Government preliminary approved the draft legislative decree implementing Directive EU 2019/1937 (so called “Whistleblowing Directive”), aimed at protecting whistleblowers against retaliation and other negative consequences.
Several Regions and Autonomous Provinces published the measures requiring medical device companies to pay, within 30 days, payback amounts aimed at covering the overrun of the expenditure ceiling for the purchase of medical devices for the years 2015, 2016, 2017 and 2018.