Food & Drug Regulatory

Subscribe to Food & Drug Regulatory

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opinion recommends the Court of Justice to deny novel food status to such ingredients under the old legal regime of now repealed Regulation 258/97.  …
Continue Reading Advocate General delivers Opinion on Novel Food Status of Insects

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 from April 29 to May 10, 2019.

The new PFOA restrictions will have significant impact on a wide variety of products marketed, and businesses operating, in the EU/EEA, including semiconductors, textiles, firefighting products, pharmaceuticals, medical devices, and materials used in the life sciences industry.  In effect, the new restrictions implementing the Stockholm Convention are significantly broader than the restrictions on PFOAs that were introduced under the EU REACH Regulation in 2017, and which the Commission now intends to repeal. …
Continue Reading Manufacturers and Marketers Beware: The EU Adopts New Restrictions on Products Containing PFOAs

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 environmentally-friendly food systems.  The Strategy is one of the main pillars of the European Green Deal that, in December 2019, the European Commission announced as its policy flagship for the next five years.
…
Continue Reading The European Commission Announces a Sustainable Food Strategy for Europe

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…

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…

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…

As previously reported on this blog, on 1 April 2020 Belgium adopted a complete ban on exports of certain medicines and raw materials to non-EEA countries to avoid shortages during the COVID-19 outbreak. On 8 April 2020, Belgium reversed this ban, and instead installed a system of export controls. Coincidentally or not, the…

On 8 April 2020, the European Commission published its Communication on the “Temporary Framework for assessing antitrust issues related to business cooperation in response to situations of urgency stemming from the current COVID-19 outbreak” (the “Framework“).

The Commission recognizes that supply chains have been severely disrupted due to COVID-19, combined with…

As reported previously on this blog, several member states have imposed bans, requisitioned stock and applied various other control measures on medicines and protective equipment (e.g., Belgium, Bulgaria, the Czech Republic, France, the Netherlands, and Poland). On 8 April 2020, the European Commission (“Commission”) issued Guidelines on the optimal and rational supply of…

1. Summary

On 1 April 2020, the Belgian Federal Authority for Health and Medicinal Products (“FAMPH”) adopted a Decision to avoid shortages of medicines and raw materials used in the treatment of COVID-19.  It applies for one month from 1 April, renewable.  On 2 April 2020, the authority provided further details in a news post…