On 7 June 2018 the European Parliament (EP) ENVI Committee discussed the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on health technology assessment (COM/2018/051 final) presented by the European Commission on 31 January 2018. The HTA proposal seeks to boost cooperation amongst EU Member States for assessing health technology. The […]
Following a positive assessment by the US Food and Drug Administration (FDA), Lithuania and Ireland have today joined the list of EU countries recognized as capable to carry out good manufacturing practice (GMP) with regard to inspections of sites that manufacture human medicines. The FDA recognized eight EU countries on 1 November 2017 and four […]
The Council of the EU authorized the European Commission to open trade negotiations with Australia and New Zealand and adopted negotiating mandates for each of the negotiations. The trade agreements with both these countries seeks to further reduce the existing barriers to trade, remove custom duties on goods, and give better access for services and […]
The Council agreed on a general approach regarding a draft regulation aimed at improving the mutual recognition of goods marketed in another member state. The regulation seeks to ensure that goods lawfully marketed in one member state can be sold in any other, as long as they are safe and respect the interests of the […]
The European Commission made a proposal for a new Regulation amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (COM / 2018/317 final). The proposal aims to adjust intellectual property rights framework, which sustains the pharmaceutical industry’s world-class innovation capacity. To improve the current system and remove a major competitive disadvantage […]
On 1 June 2018 the EU launched legal proceedings (consultation procedure) in the WTO against Chinese legislation which, according to the EU, undermines the intellectual property rights of European companies. European companies going to China are forced to grant ownership or usage rights of their technology to domestic Chinese entities and are deprived of the […]
Judgment of 21 November 2018 in Case C-29/17 Novartis Farma SpA / Agenzia Italiana del Farmaco (AIFA) e.a. The EU Court of Justice (ECJ) has ruled that under Articles 3 and 6 of Directive 2001/83 relating to medicinal products for human use and Articles 3, 25 and 26 of EU Regulation n° 726 / 2004 […]
Judgment of the GCEU, 9th Chamber, 26 November 2018 (Case T-458/17), Harry Shindler e.a. v / Council of the European Union The General Court of the European Union (GCEU) ruled that British citizens residing in other Member States than the United Kingdom are not entitled to seek the annulment of the decision of the Council of the European Union to start EU exit negotiations following the Brexit referendum because that decision does not produce […]
European Commission, Press Release, ‘EU and Mexico conclude negotiations for new trade agreement’ 28 April 2020 The negotiation phase of the new trade agreement between the European Union and Mexico was concluded by the Trade Commissioner Phil Hogan and the Mexican Minister of Economy Graciela Márquez Colín. Mexico is an important trade partner for the […]
Joined cases C‑101/19 and C‑102/19 (Deutsche Homöopathie-Union (DHU) Arzneimittel GmbH & Co. KG v Bundesrepublik Deutschland) Judgement of the Eighth Chamber 23 April 2020 The Court of Justice of the European Union prohibited the inclusion of additional information in the package leaflet of medicinal products other than that listed in Article 69 of Directive 2001/83/EC […]
