New Regulation EU 2024/1701: What Changes for Medicine Authorisation Variations?
This year will open with the entering into force of the 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 the marketing authorisation of medicinal products for human use.
The new Regulation 2024/1701 intends to establish a simpler, clearer and more flexible framework on variations, without giving up public health protection.
What’s New in Regulation EU 2024/1701: A Simpler and More Flexible Approach for Medicine Marketing Authorisation Variations
Let’s try and summarise the main new developments introduced by Regulation 2024/1701:
Unforeseen variations as per Article 5
The new Regulation requires that EMA, in cooperation with the Member States, annually reports to the Commission on recommendations on unforeseen variations referred to in Article 5 and provides information on necessary updates to be included. The Commission commit themselves to assess, without delay, the information received and integrate new classification of variations and necessary updates of the guidelines.
Biological medicinal products
Science and technology advances and decades of experience enable to change any previous approach providing for the classification of some variations as type II, and to apply a risk-based approach.
Grouping of variations
The grouping of variations is extended to enable more flexibility and to increase harmonisation. For the grouping of type IA variations referred to a MA, this kind of variations not requiring immediate notification should be grouped and submitted “as an annual update of type IA variations”, within 12 months following the implementation of the oldest variation. Alternatively, one or more type IA variations referring to different marketing authorisations of the same holder can be submitted as one single notification in a “super-grouping”.
Coronavirus vaccines
Based on the experience gained from the COVID-19 pandemic, it is appropriate to introduce similar possibilities to change the composition for other vaccines to address a public health emergency. Also the examination of variations concerning changes to the active substance to annually update a human coronavirus vaccine should follow the same rules as influenza vaccines.
Public health emergency
The new Regulation 2024/1701 introduces the possibility to change the composition of human vaccines in case of acknowledged public health emergencies , even if certain pharmaceutical, non-clinical or clinical data are missing. This innovation comes from the experience acquired during the COVID-19 pandemic.
EMA Guidelines
To support the application of the new provisions, the European Medicines Agency (EMA) published a series of guidelines specifically addressing the procedures regarding the various types of variations and the documents to be submitted.
Moreover, the European Commission examination of the proposals to amend the guidelines on the variation categories and the relevant procedures should be concluded within 2025. Until the new regulation becomes effective, MA holders shall keep referring to the current classification and guiding documents published in late October 2024 and available on the EMA website.
