The new Royal Decree 3/2023 has been published, which establishes the technical-sanitary criteria for the quality of drinking water as well as its control and supply. In this way, the European regulations have been transposed to the national level, with the main goal of improving health protection against the contamination of water intended for human consumption, regardless of its final purpose.
The AEMPS (Spanish Medicines and Medical Devices Agency) has published new guidelines on how conduct clinical investigations with medical devices, in order to adapt them to the EU Regulation 2017/745. The main changes include adjustments regarding the requirements for approval of clinical investigations, modifications to the procedures and deadlines and the documentation required.
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.
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.
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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.