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Publication of Regulation Revising Variations Framework for Medicines for Human Use

  • 17/06/2024
  • News

Today, on 17 June 2024, the Official Journal of the European Union publishes Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 “amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use” (the New Regulation) (see, attachment). The New Regulation, which will apply from 1 January 2025, purports to establish a simpler, clearer and more flexible framework on variations, without giving in on public health protection. It takes stock of the feedback which the European Commission (Commission) received in consultations launched in August 2023 (see, Van Bael & Bellis Life Sciences News and Insights of 1 September 2023).
Here are the key novelties brought about by the New Regulation: 

  • More frequent updating of classification guidelines – The New Regulation requires the European Medicines Agency (EMA) to report annually to the Commission on recommendations regarding unforeseen variations that result in the new classification of variations and regarding updates to be included in the Commission’s guidelines “on the details of the various categories of variations, on the operation of the [variation] procedures [...] and on the documentation to be submitted pursuant to those procedures” (see, Chapter 5 of Volume 2A of EudraLex). The New Regulation notes that “[t]he Commission shall without undue delay consider the report and integrate new classification of variations and necessary updates to the guidelines”. 
  • Super-grouping of variations and work-sharing – The New Regulation extends the possibility for marketing authorisation holders (MAHs) to group several variations in a single submission by making it possible to make a single submission of (minor variations of type IA) variations to the terms of more than one (national) marketing authorisation. This makes it easier for MAHs to harmonise their purely national marketing authorisations in different EU Member States. Further, work-sharing procedures are created to avoid duplication of work by national competent authorities in the evaluation of variations. 
  • Biological medicines – The New Regulation abandons the earlier approach of classifying some of the quality changes related to biological medicines by default as major variations. It notes that scientific and technological progress as well as decades of experience in the production of biological medicines have made it possible to apply a risk-based approach to these changes. 
  • Public health emergency – The New Regulation introduces the possibility of changing the composition of human vaccines addressing a recognised public health emergency, even if specific pharmaceutical, non-clinical or clinical data are missing. This novelty results from the experience gained from the COVID-19 pandemic. During the pandemic, adaptations were made to the variations system to enable changes to the composition of COVID-19 vaccines so as to protect against new or multiple variant strains. 
  • Coronavirus vaccines outside public health emergency – Aiming to streamline updates of human coronavirus vaccines outside of public health emergencies, the New Regulation makes the examination of variations concerning changes to the active substance of human coronavirus vaccines for the purposes of their annual update subject to the same rules as influenza vaccines. 

Veterinary medicines – Having regard to the fact that variations to the terms of marketing authorisations for veterinary medicines are now governed by Regulation (EU) 2019/6 of 11 December 2018 “on veterinary medicinal products and repealing Directive 2001/82/EC”, the New Regulation removes all references to veterinary medicines from Regulation (EC) No 1234/2008. 

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