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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

Assisted Decision-Making: New Act Ensures Certainty Ahead Of Deadline

The Assisted Decision-Making (Capacity) (Amendment) Act 2026 was enacted on 31 March 2026 and addresses a practical issue that has arisen in reviewing existing wardship cases under the timeframe provided for in the existing legal framework.

Ireland Healthcare

AC

Arthur Cox

Off To The Court Of Justice: Medical Claims On Food Products

Last summer, three of our clients attended an extensive hearing before the Council of State, which addressed the fundamental question of the legal framework under which...

Luxembourg Healthcare

GA

Global Advertising Lawyers Alliance (GALA)

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

A

Altius

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

European Union Healthcare

AO

A&O Shearman

Malta Introduces New Digital Health Screening System For Foreign Workers

Malta Healthcare

CG

CSB Group

Greece Introduces Digital Age Checks For Alcohol, Tobacco And Other Non-tobacco Products

Greece Healthcare

YL

Your Legal Partners

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

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

A

Altius

The EU Pharma Package: The Transferable Exclusivity Voucher Compromise Proposal

European Union Healthcare

CM

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

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Webinars

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Recorded on 20 Jan 2026 | 3:00 PM

2026 Canadian In-House Counsel Report: Unparalleled Insights into Canada's In-House Profession from CBA In-House Lawyers

TC

CBA In-House Lawyers

Recorded on 24 Jun 2025 | 3:00 PM

(2nd Session) 2025 Global In-House Counsel Survey Report: Unique Insights into the Global In-House Counsel Profession

IC

In-House Counsel Worldwide

Recorded on 24 Jun 2025 | 9:00 AM

(1st Session) 2025 Global In-House Counsel Survey Report: Unique Insights into the Global In-House Counsel Profession

IC

In-House Counsel Worldwide

Recorded on 30 Apr 2025 | 2:00 PM

Mondaq | 2025 Law Firm Data Landscape Report

mm

Mondaq

Food and Drugs Law

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

Off To The Court Of Justice: Medical Claims On Food Products

Last summer, three of our clients attended an extensive hearing before the Council of State, which addressed the fundamental question of the legal framework under which...

Luxembourg Healthcare

GA

Global Advertising Lawyers Alliance (GALA)

Indications géographiques : quand les noms des boissons alcoolisées deviennent un enjeu commercial mondial

Scotch, Tequila, Cognac ou Prosecco : derrière ces noms se cache un puissant levier juridique, l’indication géographique.

NG

Novagraaf Group

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

European Union Healthcare

AO

A&O Shearman

Economics Weekly Alert 12/2026

Cyprus Strategy

Ki

KPMG in Cyprus

Greece Introduces Digital Age Checks For Alcohol, Tobacco And Other Non-tobacco Products

Greece Healthcare

YL

Your Legal Partners

The EU Pharma Package: The Transferable Exclusivity Voucher Compromise Proposal

European Union Healthcare

CM

Crowell & Moring LLP

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

France Healthcare

DA

Delsol Avocats

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

France Healthcare

DA

Delsol Avocats

See more

Healthcare

Assisted Decision-Making: New Act Ensures Certainty Ahead Of Deadline

The Assisted Decision-Making (Capacity) (Amendment) Act 2026 was enacted on 31 March 2026 and addresses a practical issue that has arisen in reviewing existing wardship cases under the timeframe provided for in the existing legal framework.

Ireland Healthcare

AC

Arthur Cox

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

A

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

Malta Introduces New Digital Health Screening System For Foreign Workers

Malta Healthcare

CG

CSB Group

Greece Introduces Digital Age Checks For Alcohol, Tobacco And Other Non-tobacco Products

Greece Healthcare

YL

Your Legal Partners

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

France Healthcare

DA

Delsol Avocats

Malta Citizenship By Merit Law Explained

Malta Immigration

CC

Chetcuti Cauchi Advocates

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

See more

Life Sciences, Biotechnology & Nanotechnology

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

A

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

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

A

Altius

The EU Pharma Package: The Transferable Exclusivity Voucher Compromise Proposal

European Union Healthcare

CM

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

See more

Latest Videos

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Healthy Byte | Live From HIMSS 25! (Video)

AB

Alston & Bird

Zadłużona Służba Zdrowia

KHG Hupajlo Grzegorczyk & Partners

Lex Inside - L'Actualité Juridique - Émission Du 28 Juin 2024 (Video)

J

Jeantet

Episode #12 | European Health Data Space Regulation | 1 December 2022 (Video)

AM

Arendt & Medernach

Launch Of Our Medical Device Publication (Video)

WF

William Fry

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