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3 March 2022
in European Law

Product Safety – 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 […]

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3 March 2022
in European Law

Product Safety and Medical Devices

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 […]

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3 March 2022
in European Law

Directive on Product Safety 2021/0170 – COD – Ordinary legislative procedure (ex-co-decision procedure)

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 […]

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21 July 2021
in European Law

INVALIDITY PENSIONS

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 […]

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21 July 2021
in European Law

NEW EUROPEAN REGULATION ON MEDICAL DEVICES

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 […]

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21 July 2021
in European Law

Safe products in the EU single market : Commission acts to reinfurce trust

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 […]

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