European Union

In recent weeks, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published further guidance relating to the implementation of the Windsor Framework.  From 1 January 2025, changes due to the Windsor Framework for the licensing, labelling and wholesale dealing of human medicinal products in the UK will become effective.  The new measures require, amongst other things: (i) all human 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”) requirements to UK-wide packs. 

Following the MHRA’s initial publication of guidance focusing on the changes to labelling and packaging (please see our blog post here), the Agency has now issued guidance relating to wholesalers and manufacturers (“Wholesaler and Manufacturer Guidance), licensing (“Licensing Guidance”) and advertising (“Advertising Guidance”).

We explore some of the key requirements and recommendations for supply chains and promotional material arising from this new guidance below.

Continue Reading Are you Windsor Framework ready? A focus on pharmaceutical supply chains and promotional material

In an earlier blog, we had reported on an interesting litigation case concerning the legal scope of the market exclusivity right for orphan drugs in the EU. Meanwhile, there have been further developments in this court case and its key questions have now been referred to the European Court…

Continue Reading European Court of Justice requested to clarify the scope of the market exclusivity right for orphan drugs – German courts remain divided

The European Medicines Agency (EMA) has announced that it will expand its activities under its clinical data publication policy (CDP Policy, also known as Policy 0070) to cover all clinical data submitted under new marketing authorization applications (MAAs) for medicinal products as well as any applications for line extensions or

… Continue Reading EMA Clinical Data Publication Policy to Cover All New Marketing Authorization Applications, Line Extensions and Major Clinical Type II Variations Starting Q2 2025

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

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 Products

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

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 Agency

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 Claims

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 Devices

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