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Data and AI in Medicines Regulation: EMA and HMA Work Plan
The European Medicines Authority and the Heads of Medicines Agencies have published a three-year ...
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Update: Transposition of Revised Product Liability Regime by 2026
The Revised Product Liability Directive came into force six months ago and must be transposed int...
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Article and Insights
The Innovation Race in Pharma and Healthcare Sectors
In the pursuit of next-generation therapies, several trends are emerging in the pharma and health...
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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...
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...
Consultant
Alicia Compton
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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...
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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...
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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...
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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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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
New Government Legislation Programme Spring Session 2019 Published
No-deal Brexit legislation to dominate Oireachtas schedule over coming months
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Medical Devices Regulation – Applicable from Today
Amidst much anticipation, the Medical Devices Regulation becomes fully applicable across the EU f...
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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...
Partner
Charleen O’Keeffe
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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 ...
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IVDR Crunch Time – Where does Ireland Stand?
The In Vitro Diagnostic Medical Device Regulation, (EU) 2017/746, is fully applicable as of Thurs...
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IPHA’s Revised Self-Care Advertising Code
Effective from 1 March 2021, the revised IPHA Code introduces new rules for advertising non-presc...
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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...
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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...
Partner
Charleen O’Keeffe
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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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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...
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Emergency Measures to Halt the Spread of Covid-19
Government passes emergency COVID-19 Legislation
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ECJ issues Decision on SPCs for Medical Devices
ECJ rules on the availability of SPC protection for medical devices incorporating a pharmaceutica...
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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
Consultant
Margaret Muldowney
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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...
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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...
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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...
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A Stricter Regime is Beckoning for Manufacturers of Popular Beauty Devices
The European Commission has proposed reclassifying certain beauty and brain stimulation devices w...
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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...
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Third Strike for Warner-Lambert’s Lyrica® patent
The lengthy Lyrica® patent dispute between Warner-Lambert and Mylan and Actavis is over. Last wee...
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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 ...
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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.
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...
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...
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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...
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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...
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Brexit Omnibus Bill Published
Bill to prepare Ireland for no deal withdrawal by the UK working its way through legislative process
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Article and Insights
Long Awaited Periodic Payment Orders Legislation Now Commenced
Periodic Payment Orders for Catastrophic Injuries Now Commenced
Consultant
Margaret Muldowney
