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In Product Regulation & Liability

Spain: New deadline for transferring Medical Device Commercialization Communications to the CCPS application.

by 4 Mins Read

The PMPS, in which commercial communications of medical devices were registered, ceased to be operational and was replaced by the new CCPS application of the AEMPS. However, communications made to the PMPS were still valid, although they cannot be managed until they are migrated to the CCPS. Consequently, the AEMPS has set the deadline of 18 July 2023 for the transfer of marketing communications to the new CCPS application, requesting companies to retrieve them by that date, updating their information and submitting them to the necessary review by the AEMPS, prior to their inclusion in CCPS.

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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 Employment

International: Global Employment Law Fastpass for United States Multinationals (Webinar Series Invitation)

by 2 Mins Read

Join us for a four-part webinar series as our US moderators welcome colleagues from around the globe to share the latest labor and employment law updates and trends. US-based multinational employers with business operations in Asia Pacific, Europe, the Middle East and Africa, and the Americas regions will hear directly from local practitioners on the major developments they need to know, and come away with practical tips and takeaways to implement.

In Product Regulation & Liability

Spain: New Royal Decree on medical devices

by and 5 Mins Read

Royal Decree 192/2023 on Medical Devices, which adapts Spanish national regulations to the provisions of Regulation (EU) 2017/745, was published on 22 March 2023. The new Royal Decree identifies the competent authority in Spain for medical devices, expands the scope of some of the provisions to new kind of products and introduces provisions regarding the manufacture of in-house products and the reprocessing of single-use products, among other significant changes.

In ESG

European Union: Commission tables proposal for Green Claims Directive

by , and 6 Mins Read

On 22 March 2023, the European Commission tabled a proposal for a Directive on substantiation and communication of explicit environmental claims.
The proposal aims to harmonize the evaluation and monitoring of voluntary environmental claims – often referred to as “green claims” – towards EU consumers and control the proliferation of public and private environmental labels. Complementing the March 2022 proposal for a Directive on empowering consumers for the green transition as a lex specialis by providing more specific requirements on the substantiation, communication and verification of green claims, it contributes to the fight against “greenwashing”.

In Trade and Foreign Investment

Spain: Declaration of exceptionality due to drought in part of Catalonia

by and 3 Mins Read

The Resolution ACC/747/2023, of 6 March 2023, was published in the Diari Oficial de la Generalitat de Catalunya (the Official Gazette of the Catalan Government). Said Resolution declared the state of exceptionality due to hydrological drought in the exploitation units of the Llobregat Reservoirs, Ter Reservoirs and Ter-Llobregat Reservoirs and modified the states of hydrological and pluviometric drought of other exploitation units in Catalonia (Spain)

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In Employment

Europe: Industrial Action in Europe: What employers need to know now (Webinar)

by , , , , and 1 Min Read

Industrial action is on the rise throughout Europe; in this webinar we looked at the differences and similarities in the industrial action process across France, Germany, Italy, Spain, the Netherlands, Poland and the UK, the potential legal remedies in each jurisdiction and the practical steps employers can take to keep the business running.

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