With judgment No. 2434, published on 8 March 2023, the Council of State upheld the appeal against the AIFA’s decision ordering the withdrawal from the market of a homeopathic drug on the basis of a discrepancy between the drug identified in the MA renewal application and the one actually marketed.
On 20 March 2023, Regulation EU 2023/607 was published in the Official Journal of the European Union, amending the transitional provisions of Regulations EU 2017/745 on medical devices and 2017/746 on in vitro diagnostic medical devices.
Baker McKenzie’s Sanctions Blog published the alert titled Kazakhstan: Changes regarding monitoring of goods re-exported to Russia on 5 April 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine introduces a new sanctions package against Russia on 5 April 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
On 31 March 2023, the UK announced that it will join the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), joining 11 jurisdictions (including Mexico, Japan, Canada and Australia) across the Asia-Pacific region and becoming the first European country to do so. While the UK already has existing bi-lateral trade agreements with 9 of the 11 CPTPP jurisdictions, the biggest benefits will arise as other jurisdictions join the bloc (with applications to join by jurisdictions including China, Taiwan and Ecuador already submitted).
On 28 March 2023, the government presented Bill of Law 8186 (“Bill”), which provides a set of amendments to the General Tax Law (Abgabenordnung, AO) dated 22 May 1931 and introduces new procedural aspects applicable to taxpayers. The Bill also introduces new bilateral and multilateral advance pricing agreement procedures, together with the possibility to issue, withdraw or amend a tax assessment further to a mutual agreement procedure or an arbitration decision. Lastly, the Bill proposes a transfer pricing documentation requirement for transactions between associated enterprises, while further details regarding the scope, exact content and magnitude will be unveiled soon in a coming grand ducal decree.
On March 15, the Law Decree No. 24/2023 (so-called “Whistleblowing” decree) has been published in the Italian Official Gazette. The decree enhances the principles of transparency and accountability in reporting and applies to all private companies that (i) employ an average of more than 50 employees or (ii), regardless of the number of employees, are active in sectors deemed particularly “sensitive” or (iii) already have in place an Organizational Model for the prevention of crimes (so-called “231” model). The new decree introduces the obligation to set up adequate reporting channels and whistleblower protection systems.
On 29 March 2023, the Swiss Federal Council, the executive body of Switzerland, announced its decision to implement an extension of the transitional periods for the certification of medical devices under the Swiss Medical Device Ordinance (“MedDO”) and the Ordinance on In Vitro Diagnostic Medical Devices (“IvDO”), in line with the amendment of transitional provisions in the European Union under Regulation (EU) 2023/607.
The implementation of these amended transitional provisions requires the formal amendment of the MedDO and the IvDO. These amendments are expected to be adopted in autumn 2023.
On 30 March, the UK Government released a package of policy plans related to decarbonization and energy initiatives it has termed “Powering Up Britain”. Originally promoted as “green day” in Whitehall, many saw the release as the Government’s potential unveiling of a new, more detailed plan for achieving net zero emissions, as well as the UK’s response to substantial state subsidy programs announced by the US and EU. More recently, the Government sought to temper those expectations, with the release being rebranded “Energy Security Day”.
Baker McKenzie’s Sanctions Blog published the alert titled Blog Series: Sanctions Enforcement Around the G7, the Italian Perspective on 4 April 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.