European Union: Life Sciences, Biotechnology & Nanotechnology

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

New EU Sample Retention Rules Coming Up For Veterinary Medicines Repackaged For Parallel Trade

The Veterinary Medicinal Products Regulation (EU) 2019/6 has applied in the EU since 28 January 2022, replacing Directive 2001/82/EC. The new rules on good manufacturing practice (GMP) will in turn...

European Union Healthcare

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Altius

The UPC Clarifies The Threshold For “imminent Infringement”

On 13 August, the UPC Court of Appeal held that a marketing authorisation alone is not enough, but once a health technology assessment (HTA), pricing and reimbursement are completed, imminent infringement may be established. Pharmaceutical companies must therefore monitor regulatory steps closely to act in time.

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aera

European Medicines Agency SME Status – A Quick Guide

The European Medicines Agency offers special status to micro, small and medium-sized enterprises developing medicines, providing financial incentives, translation services, and regulatory guidance to foster innovation. Companies meeting specific employee and financial thresholds can access fee reductions, deferred payments, and expert support through the EMA's SME office.

Ireland Healthcare

AC

Arthur Cox

[Blog] EPO Technology Dashboard 2025 : Croissance Modérée Des Brevets Et Essor Des Technologies Numériques

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Novagraaf Group

EU AI Act Omnibus Deal Reached: Postponed Deadlines, Watermarking Compromise, And The Nudificiation Prohibition

Ireland Technology

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William Fry

EU Pharma Package: Advertising Compromise Proposal

Belgium Healthcare

CM

Crowell & Moring LLP

Court Of Appeal, April 27, 2026, Order On Provisional Measures, UPC_CoA_917/2025

BP

Bardehle Pagenberg

EU AI Act Omnibus: Provisional Deal Announced – Initial Reflections For Life Sciences Companies

Belgium Healthcare

AP

Arnold & Porter

European Health & Life Sciences Symposium 2026: Key Takeaways From Paris

France Healthcare

SR

McDermott Will & Schulte

L’actualité juridique numérique de la semaine – 5 mai 2026

France Technology

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Haas Avocats

UPC Court Of Appeal Lowers Threshold In Establishing Imminent Patent Infringement For Generic Launch

PC

Potter Clarkson

LD Brussels, April 14, 2026, Procedural Order, UPC_CFI_1357/2025; UPC_CFI_629/2025

BP

Bardehle Pagenberg

Life Sciences And Healthcare M&A 2025: A Year In Review

Ireland Healthcare

AC

Arthur Cox

Guidelines On Malta’s Tax Treatment For Highly Skilled Individuals

PS

Papilio Services Limited

The EU Pay Transparency Directive (Podcast)

Ireland Employment

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Arthur Cox

Publicité : comparer son concurrent sans risques (épisode 1) (Video)

France Media & IT

HA

Haas Avocats

Agentic AI And The Future Of Innovation Management (Video)

France Technology

innosabi

Arbitration And Business Decision (Video)

Ireland Litigation

Aceris Law

2026 Hungary Elections: What Comes Next? Insights From A Former US Embassy Diplomat In Budapest (Podcast)

Hungary Government

SP

Squire Patton Boggs LLP

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA).

European Union Healthcare

CM

Crowell & Moring LLP

EU General Court Bars Patient Association From Challenging Medicine Authorisation Refusal

In Case T‑278/25, the EU General Court recently dismissed as inadmissible a challenge brought by a patient advocacy association against the European Commission's refusal to renew the conditional...

European Union Healthcare

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Altius

Getting Ready For The EU Pharma Package Part 3: Accelerating Drug Development And Authorization

From expanded approaches to scientific advice and a shift away from animal testing to new frameworks for platform technologies...

European Union Healthcare

AO

A&O Shearman

Le nouveau décret « hébergeurs » s’aligne sur le référentiel de certification s’agissant du lieu d’hébergement

Le décret n° 2026-209 du 24 mars 2026, publié au Journal officiel du 26 mars 2026, modifie la partie réglementaire du code de la santé publique afin d’y inscrire les obligations relatives à la localisation...

France Healthcare

DA

Delsol Avocats

Despite EU Harmonisation, Member States May Impose Authorisation Requirements On Pharmacy-prepared Medicines, Rules EU Court Of Justice

Belgium Healthcare

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Altius

The EU Pharma Package: The Transferable Exclusivity Voucher Compromise Proposal

European Union Healthcare

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Crowell & Moring LLP

CJEU Rules On GDPR Access Rights And Abuse Of Rights: What The Brillen Rottler Judgment Means For Life Sciences Companies

Belgium Healthcare

AP

Arnold & Porter

Pricing And Reimbursement Of Medicines In Ireland: New Framework Agreement 2026-2029 Published

Ireland Healthcare

AC

Arthur Cox

Getting Ready For The EU Pharma Package Part 2: Stricter Rules On Environmental Risk Assessment – Everything You Need To Know

European Union Healthcare

AO

A&O Shearman

Non-compliance To The Interoperability, Ethics, And Security Standards May Be Penalized

France Healthcare

DA

Delsol Avocats

For Medical Devices, “Possible Use” Amounts To Infringement Only If The Use Is In Line With Medical Practice

AO

A&O Shearman

Belgium’s Healthcare Plans For 2026 – And Where Pharma Fits In

Belgium Healthcare

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Altius

La non-conformité aux exigences des référentiels d'interopérabilité, d'éthique et de sécurité désormais sanctionnable

France Healthcare

DA

Delsol Avocats

The EU Pharma Package: Formal Adoption In Sight

European Union Healthcare

CM

Crowell & Moring LLP

For Medical Devices, “Possible Use” Amounts To Infringement Only If The Use Is In Line With Medical Practice

The UPC Munich Local Division (the LD Munich) has dismissed an infringement action relating to a medical device. It confirmed that a device can still infringe a patent, even if it is normally operated in a non-infringing way, as long as the patent-infringing use remains possible.

AO

A&O Shearman

Belgium’s Healthcare Plans For 2026 – And Where Pharma Fits In

Every year, Belgium’s federal ministers publish their policy notes for discussion in Parliament. They give a high-level snapshot of what each minister plans to focus on in the coming year.

Belgium Healthcare

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Altius

La non-conformité aux exigences des référentiels d'interopérabilité, d'éthique et de sécurité désormais sanctionnable

(« Décret ») définissant les modalités selon lesquelles le ministre chargé de la santé peut prononcer des pénalités financières...

France Healthcare

DA

Delsol Avocats

The EU Pharma Package: Formal Adoption In Sight

With formal adoption by both the Council of the EU and the EU Parliament expected by summer 2026, stakeholders should start looking into implementation preparations...

European Union Healthcare

CM

Crowell & Moring LLP

The CNIL And The French National Authority For Health Join Forces To Support Digital Health Stakeholders

France Healthcare

DA

Delsol Avocats

The EU Pharma Package Is Finally Here – Here's The Settled Position On Key Areas

The EU Pharma Package introduces the most comprehensive reform of European pharmaceutical legislation in over two decades, fundamentally restructuring regulatory data protection, market exclusivity periods, and orphan drug incentives. With political agreement reached and formal adoption imminent, pharmaceutical companies face significant changes to data protection frameworks, supply obligations, and the expanded Bolar exemption that will reshape competitive dynamics across the European medicines market.

European Union Healthcare

KL

Herbert Smith Freehills Kramer LLP

Life Sciences: Update On National Strategy; Framework Agreements On Pricing And Supply Of Medicines

October 2025's consultation by the Department of Enterprise, Tourism and Employment (DETE) on shaping Ireland's planned new National Life Sciences Strategy...

Ireland Healthcare

MF

McCann Fitzgerald

Professional Associations Under The Health Care Professions Act

This article examines the requirements an organisation must meet to be recognised as a professional association under the Health Care Professions Act, Chapter 464 of the Laws of Malta, together with the obligations imposed on such associations ...

Malta Healthcare

GA

Ganado Advocates

NIS2 Implementation Enacted - Complete Guide

The Directive on measures for a high common level of cybersecurity across the Union (NIS2 -2022/2555) entered into force in January 2023.

Poland Technology

KL

Kobylanska Lewoszewski Mednis sp. j.

Clinical Trials Regulation In Ireland And The EU: Key Updates Shaping 2025 And 2026

European Union Healthcare

AC

Arthur Cox

The CNIL's Economic Analysis Unit Unveils Its 2026–2028 Work Programme

France Healthcare

DA

Delsol Avocats

UPC Structure – Local, Regional And Central Divisions And Court Of Appeal, Judges & Languages

KL

Herbert Smith Freehills Kramer LLP

EU Critical Medicines Act: What Life Sciences Companies Need To Know

Ireland Healthcare

MF

McCann Fitzgerald

EHDS Regulation: Secondary Use Of Electronic Health Data

Ireland Healthcare

MF

McCann Fitzgerald

AGCOM Adopts New Age Verification Mechanisms For Websites And VSPS Disseminating Adult Content

Italy Healthcare

GA

Global Advertising Lawyers Alliance (GALA)

The European Accessibility Act As Implemented In Italy: What's New For Online Pharmacies?

Italy Healthcare

GA

Global Advertising Lawyers Alliance (GALA)

The UPC's Emerging Approach To Injunctions: Patterns, Pitfalls, And Global Implications

SR

McDermott Will & Schulte

EU Agrees Landmark Reform Of Pharmaceutical Legislation

Ireland Healthcare

MF

McCann Fitzgerald

Turning Europe Into A Biotech Powerhouse: Commission Unveils Biotech Act And Regulatory Simplification For Devices

Ireland Healthcare

MF

McCann Fitzgerald

Charting Ireland's Life Sciences Strategy: Scope And Policy Priorities

Ireland Healthcare

MF

McCann Fitzgerald

Clinical Trials Reform: Ireland's Blueprint For Transforming The Clinical Trials Landscape

Ireland Healthcare

MF

McCann Fitzgerald

Advertising And Labelling Of Medicinal Products On Social Media

Ireland Healthcare

AC

Arthur Cox

EU Reaches Agreement On ‘Pharma Package’ Legislative Reforms

Ireland Anti-trust

M

Matheson

The New Product Liability Directive

Belgium Consumer

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Altius

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Latest Videos

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

WF

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)

WF

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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