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Marie Doyle-Rossi

Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics, biologics, combination products, digital health and personalized medicine.

Marie provides strategic, policy and regulatory advice on biologics, orphans, human tissue and cells, market and data exclusivity, clinical trials, pricing and reimbursement, product life-cycle management, data privacy and compliance issues.

She has developed considerable expertise in GxP, including adverse event reporting, quality systems and manufacturing, supply chains and recalls. She regularly counsels clients on “Brexit” related issues from both a UK, EU and Irish perspective.

Marie also advises on, and performs regulatory due diligence for, corporate/commercial transactions including acquisitions, public offerings and clinical trial agreements.

She is associate co-chair of Covington’s Food, Drug, and Device Rapid Response team during the COVID-19 pandemic.

Contact:Read more about Marie Doyle-RossiEmail

On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products.  This shows the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations.  The MHRA…

Continue Reading Fast-Tracking Access to New Medicines – UK Announces New International Reliance Route

On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (“SPCs”) throughout the EU.  The changes are intended to complement the new unitary patent procedure that will enter into force on June 1, 2023.  The Commission intends…

Continue Reading EU Pharma Legislation Review Series: Unitary Supplementary Protection Certificates and Recast

The European Commission’s proposal to amend the current pharmaceutical regulatory framework includes a draft Directive on medicines for human use (the “Proposed Directive”) and a draft Regulation on the central authorisation and supervision of medicines (the “Proposed Regulation”, together the “Proposal”).  In this blog, we provide an overview of the…

Continue Reading EU Pharma Revision Series: Pharmacovigilance

The European Commission’s proposal to amend the EU’s general pharmaceutical legislation includes a new draft directive replacing Directive 2001/83/EC (the draft Directive) and a new draft regulation replacing Regulation (EC) No 726/2004, which will also incorporate the EU’s amended paediatric and orphan medicine rules (the draft Regulation…

Continue Reading EU Pharma Legislation Review Series: Marketing Authorisations

More Obligations for the Same Reward?

On 26 April 2023, the European Commission published its long awaited proposal to revise the EU’s general pharmaceutical legislation.  As expected, the Commission’s proposal represents a significant overhaul of the EU medicine rules.  Not least the incorporation of the EU’s amended paediatric and orphan…

Continue Reading EU Pharma Legislation Review Series: Paediatric Medicines

This is the first in a series of Covington blogs about the EU’s proposals to amend the current pharmaceutical regulatory framework, which were released today (see here).  It introduces some of the key aims and themes and invites readers to read more in-depth summaries as we release them. …

Continue Reading EU Pharma Legislation Review Series: The EU’s proposals to amend its pharmaceutical laws released today

Complex international pharmaceutical supply chains often separate the physical flow of product from financial flows or flows of legal title. Tune in to this episode of Covington’s Life Sciences Audiocast, where Grant Castle, Robin Blaney and Marie Doyle-Rossi, discuss how the EU and UK pharmaceutical rules seek…

Continue Reading EU Talking Life Sciences Audiocast: Episode 4 – EU and UK Pharmaceutical Regulation of Tax Structures and Financial Flows – Implications for Global Supply Chains

Tune into the first episode of Covington’s Talking Life Sciences Audiocast, where Grant Castle, Peter Bogaert and Marie Doyle-Rossi discuss key developments and trends in the pharma sector. Our speakers review the major issues of 2022, including the Clinical Trials Regulation, the Health Technology Assessment Regulation, European Health…

Continue Reading EU Talking Life Sciences Audiocast: Episode 1 – Key Developments in the Pharma Sector: A Review of 2022 and Insights for 2023

In a landmark judgment on 19 November 2020, the CJEU ruled in Case C-663/18 that cannabidiol (“CBD”) is not a narcotic drug under the UN Conventions.  This is the case even where the CBD is derived from the whole cannabis plant.  The ruling provides clarity on the non-controlled status of CBD and the free movement of CBD products within the Union.  This is likely to have wide implications for the CBD industry.
Continue Reading CJEU Confirms that CBD is Not a Narcotic Drug

On 28 April 2020, the European Commission published further Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic (the “Guidance”), supported by the European Medicines Agency (EMA) and the national Heads of Medicines Agency (HMA).  The Guidance is an update to the previous version published…
Continue Reading Commission Publishes Further Guidance on Clinical Trial Conduct During COVID-19 Pandemic