European Union

In short

We won Case T-201/21 Covington & Van Vooren vs European Commission.  But why did we litigate?  Why did we ask to see how the member states voted on an EU implementing act?  A short background story, worth a few minutes of your time if interested in the EU as a democracy… 

The

On 9 June 2023, the UK Government published further guidance relating to the practical implementation of the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here).  This overarching guidance contains further detail from the Medicines and Healthcare products Regulatory Agency (“MHRA”) on the implementation

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 the new unitary SPC to

Borderline issues arise when the regulatory classification of a product, for example, as a medicine, a medical device or a food supplement, is unclear.  Uncertainty about the regulatory status of a product under development, and consequently uncertainty as to what legal rules need to be followed, can have immense consequences for developers and innovators.  To

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 potential impact of the Proposal

On April 26, 2023, the European Commission proposed the long awaited reform of the EU’s pharmaceutical regulations (see here to view our previous blogs on the subject).  This blog post discusses the data protection aspects of the proposals, which relate to the data processing activities of the European Medicines Agency (“EMA”). 

Legal basis – The

The European Commission (the “Commission”) wants to “avoid unnecessary administrative and financial burdens for applicants and competent authorities.”  As such, the Commission’s proposal for a revised Directive on the Union Code Relating to Medicinal Products for Human Use (the “Directive”) retains the Decentralized Procedure (“DCP”) and Mutual Recognition Procedure (“MRP”).  Chapter III of

The EU’s General Pharmaceutical Legislation amendment proposal, which was published on 26 April 2023 (“the Proposal”), is introducing new measures to regulate decentralized manufacturing, which is increasingly used for certain categories of medicinal products.  In particular, the Proposal introduces new obligations for manufacturers and for national competent authorities overseeing decentralized sites.  In this blog

As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“the Proposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages.  In particular, there are new obligations for Marketing Authorization Holders (“MAH”)

The latest draft pharmaceutical legislation published by the European Commission (“Commission”) is set to shake up the regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU (as discussed in further in our previous blog). As part of these developments, the Commission has clarified the concept of the Bolar exemption