Following concerns expressed about the capacity of Notified Bodies to certify medical devices in accordance with the EU Medical Device Regulation within the transitional periods provided therein, on 6 January 2023 the European Commission adopted a proposal to extend the transitional periods under Article 120(3) of the MDR.
On 22 December 2022, the Court of Justice of the European Union ruled on Case C-530/20 concerning the interpretation of Articles 86, 87, and 90 of Directive 2001/83/EC on the advertising of medicinal products for human use.
Requests for preliminary rulings made by courts of EU Member States have always been dealt with by the European Court of Justice. Over the years the CJEU handled numerous customs cases on tariff classification, customs valuation, origin and procedural customs law. Due to capacity restraints at the CJEU, an alternative distribution of jurisdiction between the CJEU and the lower EU General Court is proposed by the CJEU. More specifically, the CJEU requests that the EU Commission propose a change to the Treaty of the Functioning of the EU, such that preliminary ruling requests for, amongst others, VAT and customs matters, are to be submitted to the General Court.
On 8 December 2022, the Court of Justice of the EU rendered its first judgment with respect to the EU directive n° 2018/822 of 25 May 2018, i.e., DAC 6. The CJEU ruled that the legal obligation for a lawyer-intermediary, subject to legal professional privilege, to inform other intermediaries is invalid in light of the right to privacy, as protected by Article 7 of the Charter of Fundamental Rights of the European Union.
On 28 November 2022, the EU institutions formally adopted a Regulation on foreign subsidies distorting the internal market. The new rules will have a major impact on M&A transactions and will significantly increase the administrative burden facing many EU and non-EU companies doing business in Europe. The Regulation is part of a broader effort to protect the EU’s geopolitical “open strategic autonomy”. It aims to level the playing field by allowing the European Commission to intervene where foreign subsidies granted directly or indirectly by third countries threaten to distort the EU internal market.
On 19 September 2022, the Commission unveiled its proposal for a Regulation for the New Single Market Emergency Instrument (SMEI) to secure crucial supply chains in future emergency situations. The Commission describes the SMEI as a crisis governance framework to ensure the free movement of goods, services and persons and the availability of critical goods and services within the EU during emergencies. The SMEI is not specific to health but applies to all kinds of crises having an impact on the functioning of the single market and its supply chains. ‘Crisis’ is quite vaguely defined as an exceptional unexpected and sudden, natural or man-made event of extraordinary nature and scale that takes place inside or outside of the Union.
On Tuesday, 22 February, a meeting of the EU Foreign Affairs Ministers took place to discuss a proposed package of sanctions in response to Russia’s actions in the Donetsk and Luhansk Regions of Ukraine.
Operators may request a binding information decision from the relevant customs authorities in the EU, in order to obtain certainty about the application of customs legislation in respect of the tariff classification or the origin of imported goods across the EU. Currently, EU customs legislation does not facilitate the issuing of a binding information decision in respect the value of imported goods. This can present real challenges for importers where customs authorities across the EU adopt differing approaches on customs valuation matters, which is not uncommon, particularly for the most complex valuation matters (e.g. treatment of royalties/licence fees, assists, transfer pricing adjustments, etc.).
The Trade Specialised Committee on Customs Cooperation and Rules of Origin (the “Committee“) is scheduled to meet for the first time on Thursday 7 October. The joint EU/UK Committee was established by the EU-UK Trade and Cooperation Agreement (“TCA“) with the role of monitoring and reviewing the consistency in implementation of the TCA Rules of Origin across the EU and the UK as well as related enforcement, and to provide a joint forum for discussing related technical issues.
Following the entry into force of the new EU Dual-Use Regulation 2021/821 last month (see also our recent post), the EU has introduced new document codes that need to be used on EU customs export declarations for exports and transits of dual-use items.
Notably, specific codes now apply depending on the relevant (type of) authorisation/licence. The old code “X002” (which was previously valid for all dual-use authorisations) has been replaced and cannot be used anymore.