The new Clinical Trials Regulation became applicable on 31 January 2022, following achievement of the full functionality by the new Clinical Trials Information System, bringing more transparency into the area of clinical trials.
With judgment No. 2149 dated 19 January 2022, the Court of Cassation acknowledged the liability of a manufacturer of medical devices for damages suffered by a patient due to their medical devices breaking during surgery.
On 23 March 2022, the “National Ethics Committee for trials conducted by public research organizations and other public organizations of a national nature” (“National Ethics Committee”) was established within the National Institute of Health (NIH) in accordance with the provisions of the decree of the Ministry of Health dated 1 February 2022. The National Ethics Committee was settled on 23 March at the Italian NIH to replace the Ethics Committee of the NIH, which has been in office until now.
On 16 February 2022, the Decree of the Ministry of Health dated 30 November 2021 governing the assignment for registration and commercial purposes of data relating to nonprofit clinical studies (“Decree”) was published in the Official Gazette. Said Decree repeals the previous Ministerial Decree dated 17 December 2004.
On 16 February 2022, the European Commission published the final version of Annex 21 to the Good Manufacturing Practice (GMP) Guidelines governing the importation of medicinal products, which will enter into force on 21 August 2022.
We are pleased to introduce you to ERIC, our digital Employment Risk Check.
With a few clicks, ERIC uses a traffic light system to tell you whether there is room for improvement in your company’s employment law compliance.
On 17 February 2022, the we launched our Central Asia in Focus webinar series, discussing trends, challenges and opportunities in the region. In our five-episode webinar series, we will be discussing a wide range topics with experts from Banking & Finance, corporate, regulatory and other practices.
Episode 1: Update on recent developments in Kazakhstan: Aviation
Episode 2: Data protection and Covid-19: Trends, insights and comparison with the GDPR
On 20 April 2022, the French government adopted an ordinance adapting French law to EU Regulation 2017/745 on medical devices (MDR). Although the MDR is directly applicable since its entry into force on 26 May 2021, adaptations of the provisions of the French Public Health Code were necessary and much awaited by the medical device industry.
In its recent judgment (24 March 2022 – C-533/20, Somogy Megyei Kormányhivatal/Upfield Hungary Kft.), the European Court of Justice has decided how specific the labeling of vitamins in the list of ingredients of food must be. The court ruled that indicating the specific vitamin formulation (e.g., “cholecalciferol”) is unnecessary. Rather, using the more general name of the vitamin such as “Vitamin D” in the list of ingredients is sufficient. In addition, the judgment of the court can be understood in such a way that indicating the more complex vitamin formulation in the list of ingredients might even be prohibited.
Baker McKenzie’s Sanctions Blog published the alert titled Taiwan issues list of Russia-related export controls on 8 April 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.