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Product Regulation & Liability

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In Product Regulation & Liability

EU: New developments in breeding products, animal health and traceability requirements

by 4 Mins Read

The new Delegated Regulation (EU) 2023/647 has amended the former Delegated Regulation (EU) 2020/686, which in turn complemented Regulation (EU) 2016/429, on the prevention and control of transmissible animal diseases, animal health requirements and traceability of animal reproductive products. The new Regulation complements the rules laid down in the original regulation as regards animal health issues of traceability and certification of movements of captive breeding products of terrestrial animals. Furthermore, the main objective of the regulation is to unify the different regulations applicable on this matter in order to improve their application and to avoid duplication or cross-references.

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In Product Regulation & Liability

Spain: New indications from the AEMPS on the adaptation of veterinary medicinal products to European Regulation

by 4 Mins Read

The AEMPS has published new indications on the adaptation of veterinary medicinal products to the content of Regulation (EU) 2019/6, which establishes a period of five years for veterinary medicinal products authorized under the previous legislation to adapt to the provisions of the new Regulation. For this reason, the Quality Review of Documents has been adapted to version 9.0 on the summaries of product characteristics, package leaflet and labelling of veterinary medicinal products.

In Product Regulation & Liability

Italy: Payback on medical devices – the Administrative Court of the Lazio Region on the deadline for the payment of payback amounts

by 1 Min Read

With decree dated 7 April 2023, the Administrative Court of the Lazio Region rejected the request of a medical device company to shorten the statutory time limit for discussing its petition to suspend the enforcement of payment orders issued by Regions and Autonomous Provinces pursuant to the Italian payback legislation.

In Antitrust / Competition

Italy: Confindustria Dispositivi Medici files complaint with European Commission against the payback mechanism

by 1 Min Read

In a press release dated 3 April 2023, Confindustria Dispositivi Medici (the Italian Association of Medical Device Companies) announced the submission to the European Commission of a complaint to initiate infringement proceedings against Italy for the breach of the EU legislation on the matter of competition, market access and public procurement resulting from the Italian law governing the payback for medical devices.

In Product Regulation & Liability

Italy: Publication of the proposal for the revision of the EU pharmaceutical legislation

by 2 Mins Read

On 26 April 2023, the European Commission presented its long-awaited proposal for the review of the pharmaceutical legislation. The main objectives of the proposal include the creation of a Single Market for medicines aimed at ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines; the offering of an attractive and innovation-friendly framework for research, development, and production of medicines in Europe; the drastic reduction of the administrative burden by speeding up procedures significantly, reducing authorization times for medicines, so they reach patients faster; and the enhancement of the availability of medicines.

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In Antitrust / Competition

United Kingdom: Introducing Regulation of Digital Platforms and New Competition and Consumer Protection Reforms

by and 1 Min Read

The UK Government published on 25 April 2023 its long-awaited Digital Markets, Competition and Consumers Bill. The Bill introduces radical new digital sector regulation – akin to the EU’s Digital Markets Act – in addition to expanding the UK Competition & Markets Authority’s consumer protection powers and introducing significant reforms for the UK competition regime.

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