Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance) This Regulation aims to achieve a high level of protection of health for patients and users while ensuring the smooth functioning of the internal market as regards medicinal products, […]
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1280 of 2 August 2021 – as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council Article 93(1)(j) of Regulation (EU) 2019/6 requires the holders of a manufacturing authorisation to use only active substances which […]
REGULATION (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices Current stage – In Force Who is in charge – European Parliament and Council of EU The Covid-19 pandemic has highlighted […]
The EU rules on product safety are defined within the General Product Safety Directive (GPSD) 2001/95. Under this directive a product can only be deemed safe if it meets all statutory safety requirements under European or national law. The EU legislator is seeking to repeal the GSPD and amend regulation 2012/1025 that deals with the […]
C‑623/13, Ministre de l’Économie et des Finances v Gérard de Ruyter, 26 February 2015 The European Court of Justice (ECJ) has ruled that French legislation which requires foreigners who reside in France and who are employed by a company located in another EU Member State – and who are thus submitted to the social […]
Case C-527/13, Lourdes Cachaldora Fernández v Instituto Nacional de la Seguridad Social (INSS) and Tesorería General de la Seguridad Social (TGSS), 14 April 2015 The European Court of Justice (ECJ) has ruled that Spanish legislation on the calculation of permanent invalidity pensions is compatible with European Union law. In the present case, the Spanish legislation […]
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC The 5th of April 2017, a new European Regulation 2017/745 on medical devices was adopted by the European […]
The European Commission has tabled two legislative Proposals to make it less demanding for undertakings, particularly SMEs, to sell their items across the European Union and to reinforce controls by national specialists and customs officers to keep perilous items from being sold to European customers. The activities are intended to enhance two parts of the […]
On 19 March 2018, the EU and the UK have agreed terms for a 21-month transition after Brexit. This agreement is conditional upon the two Parties reaching an agreement on the complete withdrawal of the UK from the EU which is expected to take place in March 2019, which will be the date from which […]
On 31 May 2018, in case 537/17 Claudia Wegener v. Royal Air Maroc, the European Court of Justice (ECJ) ruled that EU Regulation 261/2004 on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights, applies to passenger transport effected under a single booking and comprising, […]
