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Pharmaceuticals Policy in the EU

Latest news on the pharmaceutical policies of the European Union.

EU, US agree pharmaceuticals mutual recognition
The EU and the United States have completed a Mutual Recognition Agreement, with both sides agreeing to reduce barriers and increase trade in pharmaceuticals as part of ongoing EU-U.S. trade talks.

EU launches ICT, pharma cases against India, Turkey at WTO
The EU brought two disputes in the World Trade Organisation against India and Turkey Tuesday, respectively targeting unlawful import duties on IT products and unlawful measures on pharmaceuticals.

Drug use increase in European cities: wastewater report
The latest findings from the largest European project in the emerging science of wastewater analysis were presented Thursday by the Europe-wide SCORE group, in association with the EU drugs agency.

Strategic approach to pharmaceuticals in the environment
The European Commission adopted on 11 March a Communication outlining a set of actions addressing the multifaceted challenges that the release of pharmaceuticals poses to the environment.

New EU rules on fake drugs enter into force
New rules on safety features for prescription medicines sold in the EU entered into force Saturday, heralding the introduction of end-to-end verification and safety features on prescription medicines.

Falsified medicines
Falsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they have not been properly checked for quality, safety and efficacy, as required by strict EU authorisation, they can pose a real risk to your health. As falsified medicines become more sophisticated, the risk of them reaching patients in the EU increases. They represent a serious threat to global health and call for a comprehensive strategy both at European and international level.

New safety features for medicines sold in the EU
As of 9 February 2019, the new rules on safety features for prescription medicines sold in the EU will apply.

Boost for joint European assessment of medicines
A new law adopted by the European Parliament on Wednesday aims to avoid duplicating national assessments to determine a medicine's added value that help EU countries decide on pricing.

Drugs report highlights resurgence of cocaine in Europe
The European Drug Report 2018, issued by the EU drugs agency Thursday, highlights increased availability of cocaine in Europe, with around 2.3 million young adults having used the drug in the last year.

Supplementary protection certificate for medicinal products
The EU Commission proposed on 28 May a targeted adjustment to intellectual property rules to help Europe's pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU.

EU pharma waiver to boost generic drugs exports
The EU Commission proposed Monday to adjust intellectual property rules to help Europe's pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU.

Conditional EU approval for Bayer buy of Monsanto
The EU Commission approved Bayer's acquisition of Monsanto Wednesday, declaring itself satisfied with the parties' remedies, worth well over EUR 6 billion, to meet Brussels' competition concerns in full.

Bayer - Monsanto: the Commission's competition concerns
The European Commission approved on 21 March under the EU Merger Regulation the acquisition of Monsanto by Bayer. The merger is conditional on the divestiture of an extensive remedy package, which addresses the parties' overlaps in seeds, pesticides and digital agriculture.

MEPs call for worldwide ban on animal testing of cosmetics
The EU should launch a diplomatic drive for a worldwide ban on the animal testing of cosmetics before 2023, the European Parliament's Environment Committee said on Tuesday.

Roche and Novartis lose Avastin case at EU Court
An agreement between pharma giants Roche and Novartis to reduce use of Avastin in ophthalmology and increase use of Lucentis could constitute restriction of competition, the EU Court ruled Tuesday.

Guidance to help pharma companies prepare for Brexit
The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). The guidance document outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing authorisation to allow for the continued marketing of their medicine in the European Economic Area after the UK withdraws from the EU. The guidance has been prepared on the basis that the UK will become a third country as of 30 March 2019.

10 years of the EU Paediatric Regulation
The European Commission presented a report on 26 October to the European Parliament and the EU Council on progress made in children's medicines since the Paediatric Regulation came into force 10 years ago.

European Banking Authority and European Medicines Agency after Brexit - Commission assessment of country offers
European Commission publishes assessment of Member State offers to host European Banking Authority and European Medicines Agency after Brexit

Synthetic opioids a growing health threat: EU report
Highly potent synthetic opioids pose a growing health threat, according to an EU report Tuesday which highlights rising overdose deaths and continued availability of new psychoactive substances.

EU probes Aspen price hikes for cancer drugs
The European Commission opened Monday a formal investigation into concerns that Aspen Pharma has engaged in excessive pricing concerning five life-saving cancer medicines.

Brussels acts against drug use and trafficking
The EU Commission proposed Wednesday a new action plan on drugs to strengthen the EU's response to the newly-emerging health and security challenges in the area of illicit drug use and trafficking.

Brussels mulls new initiative on antimicrobial resistance
The EU Commission launched a public consultation Friday on possible activities to include in a new action plan to combat antimicrobial resistance (AMR) it plans to adopt this summer.

EU proposes ban on new psychoactive substance
The European Commission proposed Wednesday to subject the new psychoactive substance MDMB-CHMICA, sometimes referred to as 'Black Mamba', to control measures across the European Union.

Fees for Pharmacovigilance activities
The European Parliament voted on 16 April in favour of an EU Regulation on fees payable to the European Medicines Agency (EMA) for the conduct of pharmacovigilance activities for medicinal products for human use, which lays down the level and structure of these fees. This Memo explains the meaning and importance of pharmacovigilance in the EU, and why this legislation is necessary.

Joint purchasing of vaccines and medicines
The European Commission has approved a Joint Procurement Agreement, which will enable all EU countries to procure pandemic vaccines and other medical countermeasures as a group, rather than individually.