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.
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.
The Spanish Customs Authorities have released new guidelines on provisional customs values and simplified declarations. The aim is to clarify the utilization of simplified declarations foreseen in Article 166 of the UCC due to the high number of queries from operators.
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.
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”.
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)
Spanish Official State Gazette published Law 2/2023 on 20 February 2023, which transposes the EU Whistleblower Directive (Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of European Union law) into Spanish law.
The Spanish government has modified, once again and with immediate effect from 28 December 2022, Spanish foreign direct investment rules that were introduced in March 2020 in connection with the COVID-19 pandemic.
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.
The Spanish Agency for Medicines and Health Products has streamlined the procedure for applying for the national code (NC) of centrally authorized medicinal products. In order to have more efficient management, this change has been included in a guide containing information on the documents required for the assignment of the NC. From now on it will be possible to send the NC application as soon as the final texts have been adopted by the applicant and the regulatory agencies. Finally, it will also be possible to present the European Commission’s decision in English.