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8 July 2022
in European Law

ePrescription and eDispensation of Authorised Medicinal Products – Guidelines on the electronic exchange of health data under Cross-Border Directive 2011/24/EU

On 10 June 2022, the eHealth Network published a guideline on the electronic exchange of health data under Cross-Border Directive 2011/24/EU. The eHealth Network was established under Directive 2011/14/EU and sets up a voluntary network of Member States’ authorities working with eHealth. The guideline supports the ePrescription and eDispensation of authorised medicinal products for patients […]

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30 June 2022
in European Law

Intellectual property: Commission issues a Proposal for protection of European Union craft and industrial products

On 13 April 2022, the European Commission issued a Proposed framework regulation “to protect the intellectual property for craft and industrial products that rely on the originality and authenticity of traditional practices from their regions.” The proposal establishes intellectual property protections, creates a two-step application process for geographical indication (GI) involving approval from both the […]

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30 June 2022
in European Law

Proposal for a regulation regarding temporary importation of seven products from Moldova

The European Commission proposed a regulation on 9 June 2022 to allow for “temporary improved market access for the remaining seven products from Moldova which are still subject to tariff rate quotas when entering the EU.” The seven products are plums, table grapes, apples, tomatoes, garlic, cherries, and grape juice. The regulation serves as an […]

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30 June 2022
in European Law

Health and Food – highly pathogenic avian influenza (HPAI)

The Council of the EU released a notification on 24 May 2022 that the Council’s Working Party on Animals and Veterinary approved conclusions on a “strategic approach for the development of vaccination as a complementary tool for the prevention and control” of highly pathogenic avian influenza (HPAI), an epizootic. Conclusions do not have legal effects. […]

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27 June 2022
in European Law

Public health: New rules on in vitro diagnostic medical devices (IVDR) enter into force

As of May 26, 2022, new rules embedded in Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) have entered into force. The new rules aim to : • improve the quality, safety, and reliability of IVDR devices through a risk-based classification system• strengthen transparency and information for patients, so that pertinent information is more […]

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7 June 2022
in European Law

Health and Food – The European Union Summary Report on Antimicrobial Resistance in zoonotic and indicator bacteria from humans, animals, and food in 2019/2020

The 2019/2020 European Union Summary Report on Antimicrobial Resistance in zoonotic and indicator bacteria from humans, animals, and food was officially published on 29 March 2022. The report was conducted by the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA). The report details antimicrobial resistance by each individual […]

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25 April 2022
in European Law

EU launches first WTO case against UK over wind energy subsidy scheme

The EU has brought a WTO action against the UK government on the basis of the WTO Agreement on subsidiaries and countervailing measures (“SCM Agreement”). The EU claims that the UK has granted an unjustified State aid to UK-based beneficiaries to use UK-made wind turbines, thus breaching the principle of non-discriminatory treatment included in the […]

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29 March 2022
in European Law

Proposal for a Directive on corporate sustainability due diligence

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on corporate sustainability due diligence and amending Directive (EU) 2019/1937 – 2022/0051 (COD) On 23 February 2022, the European Commission published a proposal for a directive on corporate sustainability due diligence. This proposal for a directive aims to introduce a duty of care […]

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29 March 2022
in European Law

Absence of the obligation to mention the vitamin formula specifically used in the list of ingredients of a foodstuff

Judgment of the Court of Justice of the EU of 24 March 2022, Somogy Megyei Kormányhivatal v Upfield Hungary Kft. Upfield Hungary Kft, case C-533/20 In a judgment of 24 March 2022, the EU Court of Justice ruled that the list of ingredients of a foodstuff containing a vitamin does not have to mention the […]

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3 March 2022
in European Law

Medical Safety Regulation

Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance) This Regulation aims to achieve a high level of protection of health for patients and users while ensuring the smooth functioning of the internal market as regards medicinal products, […]

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