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Montserrat Llopart

Montserrat Llopart is a Partner in the International Commercial & Trade department and leads the Compliance and Healthcare Law practices in the Barcelona office. Her practice focuses on advising clients on regulatory, compliance, commercial contracts, consumer and acquisitions issues. She is a regular speaker and contributor to specialist conferences and publications and she is recognized by the leading legal directories as Chamber, Legal 500 and Best Lawyers and as InspiraLaw Top 50 Women List for Spain and Portugal. Montserrat headed the Barcelona office and the Firm's pharmaceutical law group in the EMEA region.

A modification of the current fertiliser products regulation (Royal Decree 529/2023) has been published. This new Royal Decree 529/2023 improves the alignment of national regulations with Regulation (EU) 2019/1009 on EU fertiliser products to avoid tensions between these two regimes. The new regulation introduces provisions on certain mixtures of micronutrients, inorganic fertilisers based on ammonium nitrate and the criteria that sub-products must meet in order to be classified as such.

At the end of June 2023, the new Royal Decree 5/2023 was published, introducing various health and social measures. Among the different legislative changes that have taken place, the most important is the modification of the Law on Guarantees and Rational Use of Medicines and Medical Devices. From now on, the autonomous communities are allowed to establish measures for dispensing medicines and medical devices remotely if there are circumstances that justify it due to the situation of the patients.

The European Medicines Agency (EMA) has published a number of recommendations on good practices in securing the supply of medicinal products for human use with the aim of avoiding stockouts and reducing their possible consequences. The document states that ensuring the availability of authorized medicines in the European Union is a priority for the EMA. Among the recommendations published are the obligation to inform the national authorities of shortages of medicines as early as possible and to provide detailed information so that preventive measures can be implemented.

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 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.

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.

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.

The publication of the July 2022 version of the European Commission’s Blue Guide on the implementation of European Union product rules aims to adapt to changes in European legislation on the marketing of products within the EU. In this sense, the aim is to improve the understanding of EU legislation and its application in the fields that make up the single market. The Guide is for guidance only, which means that it has no legal force. Among the most relevant changes are the introduction of specific sections on product repairs, software, online sales and Brexit.