News & Analysis as of

Inspections European Union

Katten Muchin Rosenman LLP

Freedom of Breach: EU Commission Finds Pierre Cardin and Ahlers Group in Violation of Antitrust Rules - Katten Kattwalk | Issue 26

French fashion house Pierre Cardin (Cardin) and one of its oldest licensees, Ahlers Group (Ahlers), agreed to restrict cross-border sales and sales to specific customers. This is a clear breach of EU antitrust law, said the...more

TransPerfect Legal

GOOD MORNING EUROPE: Preparing for a Wave of Dawn Raids and Investigations Across Europe

TransPerfect Legal on

Earlier this year, TransPerfect Legal Solutions held our second conference on the Future of UK and EU Competition Regulation, bringing together a wide range of external counsel, in-house lawyers and legal technologists from...more

King & Spalding

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

King & Spalding on

On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....more

Hogan Lovells

Poland: Implementation of the EU rules on falsified medicines

Hogan Lovells on

The new law implementing the EU rules on falsified medicines which has been applicable since February 2019 (Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European...more

International Lawyers Network

Buying and Selling Real Estate in Greece

KEY FACTS OF REAL ESTATE ACQUISITIONS UNDER GREEK LAW - 1. PROCEDURE – MAIN STEPS OF REAL ESTATE ACQUISITION UNDER GREEK LAW. Acquisition of real estate property in Greece includes mainly the following steps: •...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | March 2018 #2

US, EU Near Agreement on Shellfish Trade - The U.S. Food and Drug Administration (FDA) has proposed to allow the import of raw bivalve molluscan shellfish—including clams, mussels, oysters and scallops—harvested in the...more

Hogan Lovells

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Hogan Lovells on

Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more

Hogan Lovells

FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

Hogan Lovells on

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...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

Hogan Lovells

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to...

Hogan Lovells on

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...more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

McDermott Will & Emery

The European Court of Justice Rules against Overreaching Requests for Information by the European Commission

McDermott Will & Emery on

Last week, the Court of Justice of the European Union (ECJ) ruled that the General Court of the European Union (GCEU) had been wrong when deciding that the European Commission’s requests for information sent to eight cement...more

Morgan Lewis

Joint Plan of Action Regarding Iran's Nuclear Program Announced

Morgan Lewis on

US sanctions are not immediately lifted due to the announcement. On July 14, the United States, European Union, United Kingdom, France, China, Russia, and Germany (P5+1/E3/EU+3 countries) and Iran reached a Joint...more

Akin Gump Strauss Hauer & Feld LLP

Sanctions Relief to Expect from the Nuclear Deal with Iran

On July 14, 2015, Iran and the P5+1 countries (China, France, Germany, Russia, the United Kingdom and the United States), with the High Representative of the European Union for Foreign Affairs and Security Policy, finalized...more

Morrison & Foerster LLP

What to Do When the Privacy Regulator Comes Knocking on Your Door? A Short Guide to Handling Inspections and Data Protection...

Inspections and data protection audits from regulators are on the rise across Europe, and this trend is likely to continue. The latest figures for 2012 show that the French data protection authority (Commission Nationale de...more

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