In this episode of Covington’s Life Sciences Audiocast, Marie Doyle-Rossi, Anna Wawrzyniak, and Valeria Sturla discuss the position adopted by the European Parliament on 10 April 2024 on the Commission proposal to reform the core EU pharmaceutical legislation.
Parliament’s position comes less than a year since the Commission published its proposal, and
On 10 April 2024, the European Parliament adopted its position on the Commission proposal to reform the core EU pharmaceutical legislation (see here and here). In doing so, the European Parliament has met its ambitious timeline to adopt its position before the upcoming Parliamentary elections and marks a significant step in the legislative process.
Parliament’s position comes less than a year since the Commission published its proposal, which consists of a new directive replacing Directive 2001/83/EC and a new master regulation replacing Regulation 726/2004, which will also consolidate the orphan and pediatric medicines regulations (see our prior EU Pharma Legislation Review blog series). Many of Parliament’s amendments to the Commission proposal will be seen as improvements by the innovative industry, but there remain challenges and unresolved questions.
We provide below the top 8 takeaways for industry to consider during the next phase of the legislative process, which is a detailed review by the Council.Continue Reading European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for Industry
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
On 30 August 2023, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) published detailed guidance on its recently announced new International Reliance Procedure (“IRP”) (see our prior blog and audiocast). The IRP will apply from 1 January 2024 and will replace and significantly expand on existing EU reliance procedures to apply to authorizations
Tune into this episode of Covington’s Life Sciences Audiocast, where Grant Castle, Marie Doyle Rossi, and Ellie Handy discuss the UK’s recent announcement of new international reliance routes for medicinal products and medical devices. The speakers will discuss existing EU reliance procedures offered by the UK. They will then set out 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 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products. This shows the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations. The MHRA is “focused on providing
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
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
The European Commission’s proposal to amend the EU’s general pharmaceutical legislation includes a new draft directive replacing Directive 2001/83/EC (the draft Directive) and a new draft regulation replacing Regulation (EC) No 726/2004, which will also incorporate the EU’s amended paediatric and orphan medicine rules (the draft Regulation).
Whilst the proposal maintains