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42 news articles found
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Article and Insights

High Court Confirms Scope of Duty of Care owed by Screening Service Providers

The High Court affirms there is no duty of care owned by screening services to relatives of those...

Margaret Muldowney
Consultant
Margaret Muldowney
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Article and Insights

The Importance of ESG for Employers within the Life Sciences Sector

Employers not complying with their ESG obligations face regulatory, capital, and talent retention...

Alicia Compton
Partner
Alicia Compton
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Article and Insights

To Refer or Not to Refer? High Court Provides Further Guidance on Solicitor Referrals to Medical Specialists

High Court considers expert medical evidence where the plaintiff was referred to that expert by h...

Mary Cooney
Partner
Mary Cooney
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Article and Insights

Reality Bites as Industry Forces Postponement of MDR Implementation

European Parliament votes to extend MDR transition periods to avoid supply shortages of medical d...

Mary Cooney
Partner
Mary Cooney
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Article and Insights

High Court Expresses Strong Disapproval of Solicitor Referrals to Medical Specialists

Mr Justice Twomey expresses strong disapproval of referrals to medical experts made by solicitors...

Mary Cooney
Partner
Mary Cooney
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Article and Insights

CJEU Issues Guidance on when Parallel Importers can Rebrand Generics as Branded Medicines

New CJEU guidance on rebranding parallel imported medicines.

Laura Scott
Partner
Laura Scott
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Article and Insights

Video: Brexit and Immigration Series – UK and Irish Nationals and the Common Travel Area

Karen Hennessy and Richard Smith from our Employments & Benefits team and Vincent Chung from Dixc...

Richard Smith
Associate
Richard Smith
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Article and Insights

Stamp Duty Battle: Abbvie Wins Appeal Against €587m Irish Stamp Duty

A recent decision of the Tax Appeals Commission will peak the interests of Pharma, Healthcare and...

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Article and Insights

Russia Issues Decree Providing For 0% Compensation for the Unauthorised Use of Certain IP Rights Emanating From “Unfriendly Countries”

Russia has issued a decree providing for 0% compensation for the unauthorised use by way of compu...

Laura Scott
Partner
Laura Scott
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Article and Insights

Regulatory Flexibility – Key Measures to Support Availability of Medicines and Medical Devices During COVID-19

The COVID-19 pandemic has propelled the healthcare and life sciences industries into uncharted te...

Laura Scott
Partner
Laura Scott
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Article and Insights

New Government Legislation Programme: Industry & Sector Breakdown Summer 2022

The Summer legislation programme has been published by the government. The programme includes 34...

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Article and Insights
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Article and Insights

New Government Legislation Programme Spring Session 2019 Published

No-deal Brexit legislation to dominate Oireachtas schedule over coming months

Shane Kelleher
Partner
Shane Kelleher
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Article and Insights

Medical Devices Regulation – Applicable from Today

Amidst much anticipation, the Medical Devices Regulation becomes fully applicable across the EU f...

Laura Scott
Partner
Laura Scott
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Article and Insights

Medical & In Vitro Diagnostic Devices and the AI Act: Proposed Regulatory Requirements

Artificial Intelligence (AI) is becoming an increasingly pervasive general-purpose technology, wi...

Charleen O’Keeffe
Partner
Charleen O’Keeffe
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Article and Insights

MDR Countdown – 1 Month. European Commission Updates its Rolling Plan

With the Medical Devices Regulation (MDR) set to become fully applicable next month the European ...

Laura Scott
Partner
Laura Scott
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Article and Insights

IVDR Crunch Time – Where does Ireland Stand?

The In Vitro Diagnostic Medical Device Regulation, (EU) 2017/746, is fully applicable as of Thurs...

Laura Scott
Partner
Laura Scott
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Article and Insights

IPHA’s Revised Self-Care Advertising Code

Effective from 1 March 2021, the revised IPHA Code introduces new rules for advertising non-presc...

Laura Scott
Partner
Laura Scott
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Article and Insights

Implementation of EU Medical Device Regulation May Face Delay

The European Commission has announced that it is working on a proposal to postpone the date of ap...

Laura Scott
Partner
Laura Scott
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Article and Insights

High Court Guidance on “Non-Identification” Orders in Civil Proceedings Including Medical Negligence Claims

A recent decision of the High Court illustrates the use of non-identification orders under the Ci...

Margaret Muldowney
Consultant
Margaret Muldowney
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Article and Insights

Guidance Published on Appropriate Surveillance under Article 120 of the MDR

The Medical Device Coordination Group has published guidance on the activities to be performed by...

Charleen O’Keeffe
Partner
Charleen O’Keeffe
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Article and Insights

Government Publishes Spring Legislation Programme for Spring 2021

The legislative programme for the forthcoming spring Oireachtas session has been published by the...

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Article and Insights

European Commission Proposes a Unitary SPC and/or a Unified Procedure for Granting National SPCs

The European Commission has proposed a unified procedure for granting Supplementary Protection Ce...

Laura Scott
Partner
Laura Scott
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Article and Insights

Emergency Measures to Halt the Spread of Covid-19

Government passes emergency COVID-19 Legislation

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Article and Insights

ECJ issues Decision on SPCs for Medical Devices

ECJ rules on the availability of SPC protection for medical devices incorporating a pharmaceutica...

Laura Scott
Partner
Laura Scott
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Article and Insights

Cutting Costs in Personal Injuries Litigation

New legislative changes aimed at cost savings in personal injuries to commence

Margaret Muldowney
Consultant
Margaret Muldowney
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Article and Insights

Court of Appeal Upholds Invalidity of a Combination Product SPC Applying the CJEU Test

The Court of Appeal has upheld a finding by the High Court that Merck Sharp & Dohme's Inegy SPC w...

Laura Scott
Partner
Laura Scott
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Article and Insights

Compulsory Licences on the Horizon for Drugs and Equipment?

As concerns grow globally about the availability of certain drugs and equipment in the midst of t...

Laura Scott
Partner
Laura Scott
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Article and Insights

Clinical Trials Regulation to Take Effect from 31 January 2022

The European Commission has announced that the long-awaited Clinical Trials Regulation (EU) No 53...

Laura Scott
Partner
Laura Scott
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Article and Insights

A Stricter Regime is Beckoning for Manufacturers of Popular Beauty Devices

The European Commission has proposed reclassifying certain beauty and brain stimulation devices w...

Mary Cooney
Partner
Mary Cooney
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Article and Insights

A Further Update on the Unified Patent Court

The requisite number of Member States have now joined the protocol on a European Unified Patent C...

Laura Scott
Partner
Laura Scott
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Article and Insights

Third Strike for Warner-Lambert’s Lyrica® patent

The lengthy Lyrica® patent dispute between Warner-Lambert and Mylan and Actavis is over. Last wee...

Laura Scott
Partner
Laura Scott
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Article and Insights
Laura Scott
Partner
Laura Scott
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Is Change on the Horizon for the Disclosure Regime Under Order 39, Rule 46 RSC?

In a recent decision, the Court of Appeal (CoA) considered the interpretation and application of ...

Mary Cooney
Partner
Mary Cooney
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Ireland’s M&A activity skyrockets following challenging 2020

Deal value in the first six months of 2021 is more than eight times H1 2020 figure.

Stephen Keogh
Managing Partner
Stephen Keogh
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What Regulatory Challenges are Facing the Life Sciences Sector?

Charleen O’Keeffe discusses some of the regulatory trends and challenges she sees coming down the...

Charleen O’Keeffe
Partner
Charleen O’Keeffe
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The European Unified Patent Court – is it Finally within Reach?

The German Federal Constitutional Court has rejected the latest constitutional challenge to the G...

Laura Scott
Partner
Laura Scott
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IPHA’s Revised Code of Practice for the Pharmaceutical Industry

Taking effect on 1 March 2021, the IPHA have revised their Code of Practice for the Pharmaceutica...

Laura Scott
Partner
Laura Scott
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Improved Access to Affordable Medicines – EU Proposes Radical Action

EU Commission releases its Pharmaceutical Strategy for Europe, marking the first step in its prop...

Laura Scott
Partner
Laura Scott
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Article and Insights

Low Rate of Notified Body Designations under MDR and IVDR Causes Bottleneck Concerns for the European MedTech Industry

Continuing our series of publications, in this briefing we explore which EU Notified Bodies have ...

Laura Scott
Partner
Laura Scott
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Article and Insights

Brexit Omnibus Bill Published

Bill to prepare Ireland for no deal withdrawal by the UK working its way through legislative process

Shane Kelleher
Partner
Shane Kelleher
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Article and Insights

Long Awaited Periodic Payment Orders Legislation Now Commenced

Periodic Payment Orders for Catastrophic Injuries Now Commenced

Margaret Muldowney
Consultant
Margaret Muldowney