Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance inspections. According to the press release, in 2017, approximately 5,063 drug establishments were subject to routine surveillance inspection; out of these approximately 5,063 eligible drug
The Food and Drink Federation (“FDF“) has published a report on the potential impact of rules of origin on UK food and drink exporters in the likely event that the UK ceases to be part of the EU customs union after Brexit. Rules of origin are the detailed content requirements that determine whether goods are
Initial responses to the European Commission’s public consultation on how to make the EU food supply chain fairer suggest that, bar retailers, the majority of significant stakeholders (including Member States, farmer groups, agricultural organisations and NGOs) are in favour of action at EU level to increase fairness and balance in the food supply chain. The
The House of Lords Delegated Powers and Regulatory Reform Committee has published a report on the European Union (Withdrawal) Bill which sets out its concerns on the “unfettered discretion” and “excessively wide legislative powers” given to Ministers by the Bill. The report is particularly critical of the so-called Henry VIII powers granted to Government by
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators. The new confidentiality commitment allows the regulators to share
Leaving the EU will require the most comprehensive re-writing of the UK’s statute book ever undertaken. Parliament must unpick over 40 years of integration between the UK and the EU legal systems and ensure no gaps are left in the process. The Government’s solution, the highly anticipated, formerly ‘Great’, Repeal Bill, is due to be published
The UK Government has made clear that it intends to end the jurisdiction of the Court of Justice of the EU (“CJEU“) in the UK post-Brexit. This will, unless agreed otherwise in the negotiations, result in litigants losing the ability to make references to the CJEU on questions of EU law. In the meantime, the
The Brexit process gets officially underway this week when the UK formally notifies the European Council of its intention to withdraw from the EU on 29 March 2017. The road ahead is untested and uncertain, as the UK will be the first EU Member State ever to leave the Union. Hogan Lovells will be hosting
In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug Administration (FDA) and the European Union (EU) today announced that they have enhanced their agreement on mutual recognition
On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”). The finalised versions of the draft texts are available here and here. Final Adoption of the texts anticipated in March The
The stage is set for the Euro-drama of our time. We know that giving effect to the UK’s vote for Brexit could require as many as four sets of distinct but closely linked negotiations, or “acts”, dealing with the terms of: the UK’s withdrawal from the EU; the UK’s future relationship with the EU after
The new May Government has now been fully established and has begun getting to work. Judging by last week’s notable developments, foreign affairs is top of the agenda. Brexit diplomacy: Good cop, bad cop? The Prime Minister made her first official visits to Germany and France last week to meet Angela Merkel and François Hollande.
Following on from last week’s comments from Donald Tusk and Jean-Claude Juncker about when the EU expects the UK to trigger Article 50 of the Treaty on the European Union, comments by British officials in the last week have shed further light on the road to Brexit ahead. What are the UK’s “constitutional requirements” for
After the UK Brexit referendum of 23 June the implications on the political, economic and legal relations between the UK and the EU have been discussed from many angles. But what about one of the main pillars for the successful integration of the European Single Market: State aid law? Does the end of EU membership
How well are European national judges trained in EU competition law?
One of the surprises in Theresa May’s comments yesterday was the distinction she drew between the European Union and the European Convention on Human Rights – making clear that, in her view, it was the latter that was the greater cause for concern in the sphere of national security. All too often, no such distinction
On the 12 January 2016, the European Medicines Agency (“EMA”) published an overview of comments in response to a public consultation regarding a “Draft revision of EudraVigilance access policy for medicines for human use”
On 17 December 2015, the European Medicines Agency (“EMA”) published a Reflection Paper on the chemical structure and properties criteria to be considered for evaluation of new active substance (“NAS”) status of chemical substances.
On December 28, 2015, the Government of India released the text for its revised model Bilateral Investment Treaty (BIT). In this release, the Government of India also announced that the Department of Economic Affairs will be leading all negotiations on BITs and investment chapters of trade agreements to ensure continuity between trade and investment issues.
The framework for the regulation of Unmanned Aerial Vehicles (“UAVs”) is currently intensely debated in the US, the EU and EU Member States. While the focus of this discussion relates to the operation of drones in a commercial and hobbyist environment, UAVs are also subject to export control regulation.
Belgian endives are a divisive vegetable: their bitterness delights some but repulses others. And even amongst Belgian endive enthusiast you’ll find some that prefer them raw – to maintain their crispness – while others like them cooked so that their bitterness comes out even more. But Belgian endives are no longer the exclusive battleground of
Thursday, 1 October 2015 9 am CDT / 10 am EDT / 3 pm GMT / 4 pm CET / 10 pm CST / 11 pm JST Global M&A activity has continued at a steady pace in 2015, with an increasing number of transactions raising antitrust issues under multiple merger control regimes. Beyond the U.S.
On 15 June 2015, the Council of the European Union (“Council”) adopted its position on the draft Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (“Draft Regulation”). This article discusses
On 26 February 2015, the European Commission published a progress report concerning the Commission’s five year Action Plan on Antimicrobial Resistance (“Action Plan”). The purpose of the progress report is to inform the European Parliament, the EU Member States and other stakeholders about progress to date in relation to the implementation of the Action Plan.