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.
Baker McKenzie’s Sanctions Blog published the alert titled Blog Series: Sanctions Enforcement Around the World, the Ukrainian Perspective on 4 May 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine introduces a new sanctions package against Russian IT and sports industries on 24 April 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
This report, based on Baker McKenzie’s many years’ experience with nuclear projects around the world, points to the need to implement comprehensive measures in the economic, legal, social and environmental areas, backed by strong and stable state support. This will not only significantly strengthen Poland’s energy security, but also provide a strong impetus to technological progress, new investments, the development of science, and increasing the competitive advantages of Polish companies.
AI has permeated much of the financial industry and significantly changed some aspects of how its businesses operate. Not as radical transformation of the industry, however, but as a steady trickle of new technologies and applications across the sector. Considerable risks also remain, as does uncertainty about regulatory approaches to AI. Baker McKenzie spoke with four experts to explore how AI use is likely to evolve in the financial industry in the years to come.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine introduces a new sanctions package against Russia on 5 April 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled Blog Series: Sanctions Enforcement Around the G7, the Italian Perspective on 4 April 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.