Inside EU Life Sciences

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Inside EU Life Sciences

Brexit: UK Guidance on Regulation of Medical Devices from 1 January 2021

By Sarah Cowlishaw & Katharina Ewert

September 3, 2020

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published Guidance on the regulation of medical devices from 1 January 2021 (the “Guidance”). It discusses the regulatory requirements that apply to medical devices after the end of the Brexit transitional period under the EU-UK Withdrawal Agreement. In summary: From 1 January 2021, different rules will apply to medical devices placed on the market in Great Britain (e., England, Wales and Scotland) and those placed…

Inside EU Life Sciences

New Licensing Regulations to Import Agricultural Products into the EU: What Traders Should Know to Avoid Missing Quota Allocations in 2021

By Cándido García Molyneux & Paul Mertenskötter

August 29, 2020

As of January 2021, many imports and exports of agricultural products covered by EU tariff quotas will be subject to the new licensing rules of Commission Delegated Regulation (EU) 2020/760 (“Delegated Regulation”) and Commission Implementing Regulation (EU) 2020/761 (“Implementing Regulation”) (together, “Licensing Regulations” or “Regulations”). The new Regulations introduce significant changes to – and are likely to disrupt – the trade of a wide variety of food and feed products, including beef, pork, poultry, sugar,…

Inside EU Life Sciences

Germany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for “Data Donations” for Research Purposes

By Dr. Dr. Adem Koyuncu & Valerie Mei

August 10, 2020

On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020. One of the main objectives of the bill is to make everyday life easier for patients and healthcare professionals by increasing use of innovative digital applications, while…

Inside EU Life Sciences

Advocate General delivers Opinion on Novel Food Status of Insects

By Bart Van Vooren & Loïc Waty

July 16, 2020

On 9 July 2020, Advocate General Bobek delivered his opinion on the status of edible insects (e.g., mealworms, locusts, and crickets) under the EU novel foods rules. While insects fall under the scope of the new EU Novel Food Regulation 2015/2283, the opinion recommends the Court of Justice to deny novel food status to such ingredients under the old legal regime of now repealed Regulation 258/97. …

Inside EU Life Sciences

Manufacturers and Marketers Beware: The EU Adopts New Restrictions on Products Containing PFOAs

By Cándido García Molyneux & Lukasz Gorywoda

July 16, 2020

Since July 4, 2020 the manufacture, marketing and use of perfluorooctanoic acid (“PFOA”), its salts and PFOA-related compounds (collectively, “PFOAs”), and products containing them, is significantly restricted in the European Economic Area (“EU/EEA”). The restrictions were introduced by a Commission Delegated Regulation amending Annex I to the EU POPs Regulation, and are intended to implement a decision of the ninth meeting of the Conference of the Parties to the Stockholm Convention that was held…

Inside EU Life Sciences

The European Commission Announces a Sustainable Food Strategy for Europe

By Cándido García Molyneux & Loïc Waty

May 29, 2020

The COVID-19 pandemic has focused attention on the need for resilient supply chains, including perhaps most importantly, the critical need for sustainable supplies of healthy food. In line with this, the European Commission (the “Commission) has published a Communication on a Farm to Fork Strategy (the “Strategy”) where it announces a series of legislative and policy initiatives intended to place sustainability at the center of EU food law and policy by ensuring fair, healthy and…

Inside EU Life Sciences

Commission Publishes Further Guidance on Clinical Trial Conduct During COVID-19 Pandemic

By Marie Doyle-Rossi & Anna Herrmann

April 30, 2020

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 in late March (see InsideEULifeSciences blog post here). As outlined in the Commission’s press release, the Guidance’s objective is to mitigate clinical trial disruption in…

Inside EU Life Sciences

German Government Adopts FDI Emergency Measures with Focus on Healthcare Sector

By Peter Camesasca, Horst Henschen, Sarah Hachmeister & Martin Juhasz

April 29, 2020

On 28 April 2020, the German government published a ministerial draft for an amendment of the Foreign Trade and Payments Ordinance (“Draft Ordinance”). The amendment supplements the existing Foreign Direct Investment (“FDI”) regime in order to tighten it with respect to acquisitions of critical companies in the healthcare sector by purchasers from third countries. The Draft Ordinance comes shortly after the German government proposed a new draft bill on 31 March 2020 reforming the current…

Inside EU Life Sciences

Effective date of EU Medical Device Regulation now officially delayed by 1 year

By Sarah Cowlishaw & Anna Herrmann

April 27, 2020

On 23 April 2020, the European Parliament and Council approved the European Commission’s proposal to delay the application date of the Medical Device Regulation 2017/745 (the “MDR”) by one year (from 26 May 2020 to 26 May 2021) by adopting New Regulation (EU) 2020/561 (the “New Regulation“). Unusually, the New Regulation took effect on the date of its publication in the Official Journal of the European Union, i.e., on 24 April 2020. Typically, regulations come…

Inside EU Life Sciences

Ireland’s HPRA to fast-track review of Covid-19 related Clinical Trials and Clinical Investigations

By Maree Gallagher & Marie Doyle-Rossi

April 14, 2020

The Irish Health Products Regulatory Authority (HPRA) today announced the introduction of an expedited review process for human health research related to COVID-19. The Irish Minister for Health also announced the setting up of a dedicated COVID-19 National Research Ethics Committee (NREC-COVID-19). Applications for clinical trials of human medicines or clinical investigations of medical devices will be given priority and an expedited review by HPRA. The NREC-COVID-19 will review applications concurrently with the regulatory review…

Inside EU Life Sciences

Updates on Legal Developments in the EU Life Sciences Industry

Blog Authors

Brexit: UK Guidance on Regulation of Medical Devices from 1 January 2021

New Licensing Regulations to Import Agricultural Products into the EU: What Traders Should Know to Avoid Missing Quota Allocations in 2021

Germany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for “Data Donations” for Research Purposes

Advocate General delivers Opinion on Novel Food Status of Insects

Manufacturers and Marketers Beware: The EU Adopts New Restrictions on Products Containing PFOAs

The European Commission Announces a Sustainable Food Strategy for Europe

Commission Publishes Further Guidance on Clinical Trial Conduct During COVID-19 Pandemic

German Government Adopts FDI Emergency Measures with Focus on Healthcare Sector

Effective date of EU Medical Device Regulation now officially delayed by 1 year

Ireland’s HPRA to fast-track review of Covid-19 related Clinical Trials and Clinical Investigations

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