The Medical Device Coordination Group (MDCG), the expert panel of the EU Member States and the EU Commission, has released on 20 October 2021 two guidance documents which provide meaningful guidance (1) for manufacturers, importers and distributors of “legacy devices” on which MDR obligations they must comply with (guidance document 2021-25), and (2) on the obligations of parallel importers regarding the repackaging and relabeling of medical devices under Article 16 MDR/IVDR (guidance document 2021-26).
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.
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On 30 July 2021, the Official Journal of the European Union published the Commission Implementing Regulation (EU) 2021/1248 of 29 of July 2021, as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (“Implementing Regulation”). The Implementing Regulation applies to holders of manufacturing authorizations performing wholesale distribution of veterinary medicinal products covered by that manufacturing authorization, and to holders of a wholesale distribution authorization, including those established or operating under specific customs regimes, such as free zones or customs warehouses.
On 14 July 2021, the European Commission adopted a proposal for a new Carbon Border Adjustment Mechanism, which will require importers to report the embedded emissions in certain carbon-intensive products and buy certificates to account for these emissions.
With the rise of digital platforms and the possibilities internet provides for businesses, more and more sellers are able to offer goods and services via these platforms and the internet. In this context, it has become difficult for tax authorities to trace the flow of goods and services as well as to identify sellers to ensure that these goods and services are taxed in accordance with EU tax principles.
On 11 June 2021, the Recast Dual-Use Regulation was published in the Official Journal of the European Union as Regulation 2021/821. The Regulation, which comes into force on 9 September 2021, will replace the current Dual-Use Regulation introduced in 2009.
On June 15, 2021, the White House announced that the US and European Union (EU) have reached an agreement in the 16-year WTO Boeing-Airbus dispute and agreed to address shared challenges from China. The US and EU will suspend tariffs that were authorized by the WTO that are related to this dispute for five years and work together to challenge and counter China’s non-market practices in this sector in specific ways that reflect standards for fair competition. This includes collaboration on inward and outbound investment and tech transfer.
The EU Taxation and Customs Union announced that new VAT rules on cross-border business-to-consumer (B2C) e-commerce transactions will enter into effect on 1 July. The following is from the announcement: Everyone in the e-commerce supply chain is affected, from online sellers and marketplaces/platforms both inside and outside the EU, to postal operators and couriers, customs and tax administrations, right through to consumers.
As part of its updated 2020 Industrial Strategy, the EU Commission noted that the pandemic has highlighted the trading bloc’s technological and industrial strategy dependencies, which need to be analysed and addressed as part of Europe’s economic recovery.