Doing Business in the European Union | Reporting Systems and the Importance of Culture & Language
Doing Business in the European Union | Anonymity & Keeping the Whistleblower's Identity Confidential
Doing Business in the European Union | Key Elements of the EU Directive on Whistleblower Protection
Doing Business in the European Union | Global Laws & Compliance Program
Nota Bene Episode 102: Examining European Union State Aid in the Face of COVID and Brexit with Jacques Derenne and Robert Klotz
JONES DAY PRESENTS®: EU Mandatory Disclosure Rules (DAC 6)
Nota Bene Episode 81: European Check In: How the EU is Dealing with the Pandemic’s Economic Fallout with Oliver Heinisch
Jones Day Talks: EU's New Foreign Direct Investment Regulations Eye Specific Sectors
In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
Introduction- The International Narcotics Control Board (“INCB”) released its “Report of the International Narcotics Control Board for 2022 (E/INCB/2022/1)” (the “Report”), which dedicates an entire section to discussing the...more
The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more
Following the recent agreement to delay Brexit until 31 January 2020, the UK Department of Health and Social Care ("DHSC") has written to suppliers of UK medicines and medical devices to confirm the continued contingency...more
With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more
The EMA will be launching Phase 3 of its business continuity plan on October 1, 2018 at the latest, however, the detail of the plan will now be impacted by the EMA announced this week that it has realized that it will lose...more
On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more
Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a...more