Ireland: 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.
Article
A New Era For EU Pharma
The Council of the European Union has formally adopted the EU Pharma Package, marking the most significant revision of EU pharmaceutical legislation since 2004. This comprehensive reform introduces substantial changes to regulatory protection periods, innovation incentives, medicine shortage protocols, and market access mechanisms that will fundamentally reshape how pharmaceutical companies operate across the European Union.
European Union Healthcare
WF
William Fry
Article
A New Regulatory Landscape For Veterinary Manufacturers
Since July 2026, veterinary medicines manufacturers have been subject to restructured good manufacturing practice (GMP) rules under two new EU Regulations. These standalone frameworks introduce mandatory quality obligations for finished products and active substances, replacing previous guidance-based requirements with directly applicable law. Meanwhile, the European Commission's proposed Biotech Act I aims to streamline variation procedures, simplify GMO approvals, and introduce new incentives for biotechn
European Union Healthcare
AC
Arthur Cox
Article
EU Council Adopts New EU Pharma Package
The Council of the EU has adopted the most comprehensive reform of EU pharmaceutical legislation in over 20 years, fundamentally reshaping regulatory protection mechanisms, market exclusivity periods, and incentive structures for pharmaceutical companies. These reforms balance patient access to medicines with creating a more competitive and innovation-friendly environment, addressing antimicrobial resistance, medicine supply challenges, and the early availability of generic alternatives.
Ireland Healthcare
M
Matheson
Article
Life Sciences Outlook 2026
Arthur Cox's Life Sciences Outlook 2026 examines critical regulatory developments and strategic opportunities shaping Ireland's life sciences sector. The publication explores Ireland's EU Council Presidency and its potential impact on advancing key legislative initiatives including the Biotech Act I and medical device reforms. Industry leaders will find comprehensive analysis spanning pharmaceutical compliance, medtech regulation, data governance, M&A activity, and environmental considerations.
Ireland Healthcare
AC
Arthur Cox
Article
EU Reaches Agreement On ‘Pharma Package’ Legislative Reforms
On 11 December 2025, the Council of the European Union (the “Council”) and the European Parliament (the “Parliament”) provisionally reached an agreement on the first major reform of EU pharmaceutical rules since 2004. The agreement (known as the “Pharma Package”) aims to increase patients’ access to medicinal products across the EU and to boost the competitiveness of the pharmaceutical industry.
Ireland Anti-trust
M
Matheson
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