Knowledge

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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Publications

Analysis

CJEU clarifies assessment under competition law of pay-for-delay deals in the pharmaceutical sector
Registered Content

On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case ...

Hogan Lovells Publications

Early Access to Pharmaceutical Products in Major European Markets

The European Medicines Agency (EMA) has committed early patient access to new medicines, particularly those that target an unmet medical need or are of major public health interest.

Hogan Lovells Publications

EU customs and import compliance

Conducting trade across international boundaries has become increasingly complex and challenging for businesses. Efficiently managing diverse regulatory and customs-related...

Insights

Further delay announced regarding the entry into application of the Clinical Trials Regulation
Registered Content

The entry into application of the Clinical Trials Regulation depends on confirmation of full functionality of the Clinical Trial Information System (CTIS) through an independent audit....

News

European Commission publishes new documents regarding the Clinical Trials Regulation

Shortly after updating the related draft Questions and Answers document, the European Commission has published two new documents concerning theClinical Trials Regulation(EU)...

Insights

European Commission publishes new MDR/IVDR guidance on cybersecurity for medical devices
Registered Content

The Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) will enter into application in May 2020 and May 2022 respectively. A number of changes...

Insights

European Medicines Agency's guidance on comparability for advanced therapy medicinal products
Registered Content

Changes to the manufacturing process for advanced therapy medicinal products raise questions in terms of comparability. Depending on the criticality of the changes and their impact on the...

Hogan Lovells Publications

Antitrust, Competition, and Economic Regulation Quarterly Newsletter - Autumn 2019

Read the latest news on antitrust, competition and economic regulation (ACER) in this Autumn's edition of our quarterly ACER newsletter.

Hogan Lovells Publications

Data class actions guide

Does your processing of personal data fall within the scope of the GDPR? Are you ready to defend potential data-related litigation – in particular, data class actions?

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