EU Court Overturns EU-wide Botanical Food Ban
In a precedent decision, on 13 November 2024, the EU General Court annulled significant parts of a Commission Regulation, which sought to restrict or place under scrutiny the addition of certain botanicals containing hydroxyanthracene derivatives (“HADs”) to foods. The Court held that the Commission had exceeded its powers by seeking to regulate botanical “preparations.” Moreover, the Commission, in relying on the scientific opinion of the European Food Safety Authority (“EFSA”), had failed to demonstrate that the relevant substances would be ingested in amounts greatly exceeding those consumed from a normal diet or otherwise represented a potential risk to consumers. Continue Reading EU Court Overturns EU-wide Botanical Food Ban
New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products
Today, the European Parliament approved a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) that will impose new additional costs on producers marketing pharmaceutical and cosmetic products in the European Economic Area by the end of 2027. Some studies suggest that the costs that producers would have to collectively pay could
Continue Reading New EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic ProductsEU Health Emergency Mechanisms: Impact on Medical Devices
The European Union has adopted various new rules for emergency situations relating to public health. These new measures build on the experience gained from the COVID-19 pandemic and give new powers to the European Commission, in close cooperation with the Member States.
The new rules create a complex public health
Continue Reading EU Health Emergency Mechanisms: Impact on Medical Devices
EMA announces €10 million of funding to support the establishment of the African Medicines Agency
On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency
Continue Reading EMA announces €10 million of funding to support the establishment of the African Medicines AgencyEU Adopts New Rules on Greenwashing and Social Impact Claims
On January 17, 2024, the European Parliament formally endorsed its provisional agreement with the Council on the Directive Empowering Consumers for the Green Transition through Better Protection against Unfair Practices and Better Information (“Greenwashing Directive”). The Council is now expected to endorse the provisional agreement after which the
Continue Reading EU Adopts New Rules on Greenwashing and Social Impact ClaimsSingle Market Emergency Instrument: Potential Impact on Medical Devices
The European Parliament and Council are currently negotiating the wording of a new Regulation establishing a Single Market emergency instrument (“SMEI”). This new measure builds on the experience gained from the COVID-19 crisis and gives new powers to the Commission, in close cooperation with the Member States. This blog briefly
Continue Reading Single Market Emergency Instrument: Potential Impact on Medical DevicesEU Talking Life Sciences Audiocast: Supplementary Protection Certificates – What It Means for a Product to Be Protected by a Basic Patent in Force and Future Proposals in the EU
Supplementary Protection Certificates (SPCs) are a form of patent term extension right that are available in the EU for medicinal products.
Tune into this episode of Covington’s Life Sciences Audiocast where Inga Pietsch and Roderick Dirkzwager discuss some of the developments in SPC case law from the European Court of
Continue Reading EU Talking Life Sciences Audiocast: Supplementary Protection Certificates – What It Means for a Product to Be Protected by a Basic Patent in Force and Future Proposals in the EU
New MHRA Guidance on the Windsor Framework: Detail on Labelling and Packaging Changes
On 29 September 2023, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published further guidance (“MHRA Guidance”) on changes to labelling and packaging for medicinal products intended for the UK market (including Northern Ireland) under the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here).
The MHRA Guidance follows the Agency’s announcement of new labelling and packaging measures in June 2023, which will take effect from 1 January 2025. The new measures require, amongst other things: (i) medicinal products intended for the UK market to be authorized by the MHRA; (ii) a single UK-wide pack that bears a “UK only” label; and (iii) disapplication of the EU Falsified Medicines Directive 2011/62/EU (“EU FMD”) to UK packs (please see our blog post on this announcement here).
The latest MHRA Guidance provides further detail on the above measures.Continue Reading New MHRA Guidance on the Windsor Framework: Detail on Labelling and Packaging Changes
UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)
Big news for manufacturers: the UK Government announced on 1 August 2023 that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market.
The move is a significant reversal of the UK’s previous, post‑Brexit policy. In a bid to separate the UK’s internal market from the European market, the UK promised to phase out CE marks for products marketed in England, Scotland and Wales (Great Britain or “GB”), and replace them with an equivalent “UKCA” mark. However, the project suffered from numerous delays, and the UK repeatedly extended the deadline for transitioning from the CE mark to the UKCA mark, before the recent announcement that the UK will accept CE marks indefinitely. Despite this change of policy, the UK has not abandoned the UKCA mark yet, and manufacturers may still choose to use it. Even so, it is not obvious why a manufacturer would choose conformity assessment that is recognized only in the UK over (or even as well as) conformity assessment that is recognized across the UK and the EU. What remains to be seen is whether differences between the UK and EU conformity assessment standards will lead to a kind of “forum shopping” by manufacturers.
Also, and of significant importance for medical device manufacturers, the indefinite extension of CE mark recognition does not (at least currently) cover medical devices nor in vitro diagnostic medical devices (“IVDs”). The Medicines and Healthcare products Regulatory Agency (“MHRA”) is separately consulting on international recognition of foreign approvals (including CE marks) in the medical device space.Continue Reading UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)