European Union: Life Sciences, Biotechnology & Nanotechnology

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GVZH Legal & Regulatory Updates - September Issue

Welcome to the third edition of our 2025 Legal & Regulatory Updates, where we bring you the latest developments designed to keep you informed and ahead in a fast-evolving landscape. In this issue, we cover...

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GVZH Advocates

The EU Excludes Economic Operators And Restricts The Use Of Medical Devices Originating In The People's Republic Of China

The EU adopts rules restricting the access of economic operators and the use of medical devices originating in the People's Republic of China to the EU public procurement market.

Worldwide Healthcare

BB

Bech-Bruun

European Commission Publishes New Variation Guidelines For Medicines

The European Commission has published new Guidelines on the details of the various categories of variations (to the terms of marketing authorisations ("MA") for medicinal products) ("Variations Guidelines").

European Union Healthcare

AP

Arnold & Porter

Reporting A Hospital For Negligence: Practical Guide And Deadlines To Know

Discover how to report a hospital for medical negligence: timelines, procedures and compensation. A guide for Italian and foreign patients.

Italy Litigation

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Boccadutri International Law Firm

Combination Therapies In Belgium: How To Collaborate Without Breaching Competition Law

Belgium Anti-trust

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Altius

Règlement IA : répartition des compétences entre les autorités nationales

France Healthcare

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Delsol Avocats

EU: New Guidance On The Interplay Between Medical Device Regulations And The AI Act

European Union Healthcare

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Plesner

MITM : Publication Du Décret D'application Des Mesures Introduites Par La LFSS Pour 2024 Relatives À La Lutte Contre Les Pénuries De Médicaments

France Healthcare

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Delsol Avocats

Herbert Smith Freehills Kramer Comments For LSIPR On Small Molecule Litigation In The UPC

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Herbert Smith Freehills Kramer LLP

Titanium Dioxide: General Court Strikes Down Classification As Human Carcinogen And ECJ Now Confirms

France Healthcare

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Altius

European Union And United States Agree On Import Tariffs For Pharmaceutical Products

Worldwide International

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Van Bael & Bellis

Publication d'un guide d'implémentation de l'éthique dans les systèmes d'intelligence artificielle en santé

France Technology

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Delsol Avocats

European Patent Attorney – Role, Qualifications & Career Path

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Questel

Pharmaceutical Advertising Laws And Regulations Ireland 2025

Ireland Healthcare

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Arthur Cox

Horizon Scanner Finance September 2025 - Looking Ahead: European Developments

Ireland Finance

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Arthur Cox

Ireland Moves To Enhance Its AIF Regime In Anticipation Of AIFMD 2.0

Ireland Finance

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Matheson

Stop-the-Clock Directive: Where Things Stand In Kinstellar Jurisdictions

Czech Republic Commercial

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Kinstellar

Anti-ESG Update: Navigating The Backlash On ESG

Netherlands Commercial

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Loyens & Loeff

AI And Funds Tokenization: The Regulatory Experiences In Ireland To Date

Ireland Finance

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Dillon Eustace

The New EU "Pharma Package": Interplay With The Critical Medicines Act And Other Shortage Initiatives

In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation.

European Union Healthcare

CM

Crowell & Moring LLP

A Heart Monitor At The Crossroads Of EU Data, Security And Medical Rules

A remote cardiac monitor is small enough to slip under the skin, but it changes the way a patient's heart is watched. Once in place it works quietly in the background, recording every beat and any irregular rhythm...

Malta Healthcare

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GTG

Podcast Series Episode 2: Legal Framework Of Medically Assisted Reproduction In Greece

In this episode, Senior Associates Pelina Leontiadou and Ria Venaki discuss recent legal developments and the legislative framework...

Greece Healthcare

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Bernitsas Law

The New EU "Pharma Package": Access Conditionalities And Shortage Measures – A Comparison Of Commission/Parliament/Council Positions

In this seventh alert in our weekly series on the Pharma Package, we will discuss the increasing focus on shortages of medicinal products in the EU and the prevention...

Belgium Healthcare

CM

Crowell & Moring LLP

Commission Guidelines For Providers Of General-purpose AI Models

European Union Healthcare

AP

Arnold & Porter

Exclusion Of Chinese Medical Devices From Public Procurements

Worldwide Government

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Plesner

The EU Pharma Package: Status Following The Council's Adoption Of Its General Approach

Denmark Healthcare

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Plesner

Italian Medical Device Payback: Italy Approves 75% Reduction On Medical Device Payback To End Disputes

Italy Healthcare

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A&O Shearman

New Danish Pilot Program With Reimbursement For Certain Medicines Based On A Negotiated Confidential Price

Denmark Healthcare

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Plesner

The New EU "Pharma Package": The "Bolar" Exemption – A Comparison Of Commission/Parliament/Council Positions

European Union IP

CM

Crowell & Moring LLP

European Biosimilar Updates – Formycon's Ustekinumab And Alvotech's Cetrolizumab Pegol

Germany Healthcare

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Goodwin Procter LLP

REACH Obligation To Register Imported Chemicals May Be Assumed By A Person Other Than The Buyer

European Union Healthcare

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Altius

Updates To The EU Pharmacovigilance Rules: Key Takeaways For Marketing Authorisation Holders

European Union Healthcare

AP

Arnold & Porter

The New EU "Pharma Package": Global (Orphan) Marketing Authorization

European Union Healthcare

CM

Crowell & Moring LLP

European Biosimilar Updates – Formycon's Ustekinumab And Alvotech's Cetrolizumab Pegol

On June 26, 2025, Formycon AG ("Formycon") announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH ("Ratiopharm") for the semi-exclusive commercialization...

Germany Healthcare

GP

Goodwin Procter LLP

REACH Obligation To Register Imported Chemicals May Be Assumed By A Person Other Than The Buyer

Under the EU's REACH Regulation 1907/2006, substances must be registered with the European Chemicals Agency before being imported.

European Union Healthcare

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Altius

Updates To The EU Pharmacovigilance Rules: Key Takeaways For Marketing Authorisation Holders

On 22 July 2025, the European Commission adopted Implementing Regulation (EU) 2025/1466 ("Regulation"), updating the EU pharmacovigilance (or "PV") rules by way of amendments...

European Union Healthcare

AP

Arnold & Porter

The New EU "Pharma Package": Global (Orphan) Marketing Authorization

In this fifth alert in our weekly series on the EU Pharma Package, we will delve into the global marketing authorization (GMA) concept which has largely remained untouched in the legislative proposal...

European Union Healthcare

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Crowell & Moring LLP

EU Confirms App Stores And Developers Are Subject To Medical Device Laws

European Union Healthcare

OC

Osborne Clarke

EU Consults On New GMP Rules For AI In Pharma Manufacturing

On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing.

European Union Technology

AP

Arnold & Porter

L'IA médicale de Microsoft MAI-DxO bouscule la médecine

Le géant de la technologie Microsoft a récemment présenté MAI-DxO, un système d'intelligence artificielle (IA) conçu pour assister les médecins dans les diagnostics complexes.

France Technology

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Haas Avocats

Neurotech : Au Coeur De L'esprit, Aux Frontières Du Droit

Les neurotechnologies ne sont pas simplement un nouvel outil médical. Elles constituent une révolution anthropologique majeure...

France Healthcare

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Haas Avocats

EU AI Act – Latest Regulatory Developments In Finland

In Finland, the EU AI Act will be transposed into Finnish law by way of two government proposals.

Finland Technology

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Hannes Snellman Attorneys Ltd

European Commission Consultation Shapes High-risk AI Classification For Life Sciences In The EU

European Union Healthcare

OC

Osborne Clarke

EU Guidance Details How Technical And Clinical Standards Converge For AI In Medtech

European Union Healthcare

OC

Osborne Clarke

EU Updates Regulation On Electronic Instructions For Medical Devices

European Union Healthcare

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PLMJ

Review Of A Year Of Administrative Case Law On Market Access

France Healthcare

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Dechert

Social Security Financing Bill For 2025

France Government

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Dechert

DPIAs, Clinical Trials And AI: Health Sector And Lifesciences Updates

Ireland Technology

WF

William Fry

Life Sciences Outlook 2025 - Oliver O'Connor, Irish Pharmaceutical Healthcare Association

Ireland Healthcare

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Arthur Cox

The New EU Product Liability Directive: Key Changes And Implications For The Life Sciences Sector

Ireland Healthcare

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McCann Fitzgerald

Life Sciences Outlook 2025 - Mergers And Acquisitions

Ireland Commercial

AC

Arthur Cox

Life Sciences Outlook 2025 - Environment, Construction And Real Estate

Ireland Real Estate

AC

Arthur Cox

LIfe Sciences Outlook 2025 - ESG And Energy

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Litigation, Dispute Resolution And Products

Ireland Healthcare

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Interview

Ireland Healthcare

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Regulatory And Compliance

Ireland Healthcare

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Introduction

Ireland Healthcare

AC

Arthur Cox

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Latest Videos

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What Regulatory Challenges Are Facing The Life Sciences Sector? (Video)

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William Fry

Webinar Video | Lunch & Learn: Life Sciences : Morceaux Choisis

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Altius

Webinar Video | Life Sciences Session #2: Vaccine Liability: What If Vaccination Goes Wrong?

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Altius

Launch Of Our Medical Device Publication (Video)

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William Fry

Understanding Sunshine Rules: How New Transparency Regulations In Europe Are Changing Relationships Between Industry And Health Care Professionals (Video)

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Hogan Lovells

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