News & Analysis as of

Imports European Union Pharmaceutical Industry

Husch Blackwell LLP

The US and EU Reach A Trade Deal—EU Goods Subject to 15% Tariff

Husch Blackwell LLP on

On July 27, 2025, President Trump announced that the U.S. and European Union (“EU”) have reached a trade deal. Pursuant to the Fact Sheet released by the White House on July 28th, the U.S. will impose a 15% tariff on all EU...more

A&O Shearman

UK will permanently retain its UK+ exhaustion regime to allow continued supply of medicines into the UK

A&O Shearman on

The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...more

Alston & Bird

More Tariffs Possible as Soon as Next Week

Alston & Bird on

Recent statements by President Trump suggest that next week could bring multiple and significant tariff announcements. Today, in a meeting with visiting Japanese Prime Minister Shigeru Ishiba, the President promised to...more

Hogan Lovells

MDCG guidance on QMS certification of distributors/importers relabeling, repackaging medical devices

Hogan Lovells on

In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The...more

Society of Corporate Compliance and Ethics...

A look at the EU Market Surveillance Regulation

Report on Supply Chain Compliance 3, no. 21 (October 29, 2020) - The European Union has some of the world’s most robust environmental, health and safety standards for products sold and imported into the market. Despite...more

McDermott Will & Schulte

International News: COVID-19 Global Pandemic - May 2020

The Legal Impact in Europe on Pharmaceutical and Medical Device Companies - The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across Europe. ...more

Robins Kaplan LLP

Financial Daily Dose 1.17.2020 | Top Story: Senate Passes USMCA by Wide Margin to Update NAFTA

Robins Kaplan LLP on

While there’s plenty of other business afoot in D.C. these days, it also happens to have been a pretty big week for trade deals. A day after Phase One with China was inked, the Senate overwhelmingly approved a revised...more

Robins Kaplan LLP

Financial Daily Dose 11.13.2019 | Top Story: Buffeted by Changing Consumer Demands, Dean Foods Declares Bankruptcy

Robins Kaplan LLP on

Dean Foods, the largest milk company in the U.S., has filed for bankruptcy protection, a “fresh setback to a U.S. dairy industry struggling against declining U.S. milk consumption and rising competition.”  Industry experts...more

Hogan Lovells

DHSC Update on Medicines and Medical Devices Contingency Planning

Hogan Lovells on

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

Skadden, Arps, Slate, Meagher & Flom LLP

Cross-Border Investigations Update - September 2019

This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more

McDermott Will & Schulte

European SPC Manufacturing Waiver Goes into Force

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

Hogan Lovells

The Court of Justice clarifies the EU customs rules applicable to customs valuation

Hogan Lovells on

The Court of Justice of the European Union (“Court”) just released its judgement in Case C-1/18 Oribalt Riga concerning the customs valuation methodologies applicable to generic medicines in the framework of consignment...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Hogan Lovells

UK MHRA consults on no-deal Brexit legislation

Hogan Lovells on

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

Hogan Lovells

UK publishes paper on Brexit and medicines regulation

Hogan Lovells on

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

Hogan Lovells

Brexit – the end of parallel imports from the UK?

Hogan Lovells on

The United Kingdom's unprecedented vote to leave the EU will undoubtedly cause a broad range of legal issues in the future. This post focuses on the consequences of Brexit on parallel imports - a field of significant...more

Jones Day

EU-U.S. Agreement for Mutual Recognition of GMP Inspections Entered Into Force

Jones Day on

On March 4, 2017, the "Decision No 1/2017 of March 1, 2017, of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: Court of Appeal Refers Questions on Specific Mechanism to Court of Justice of European Union

Merck Canada Inc and Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals plc - Prior to their accession to the European Patent Convention, several states did not allow patent protection for pharmaceutical products. To...more

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