 2024/1701 applies to post-authorisation variation applications for centrally authorised regulatory dossiers submitted to the authorities as of 1 January 2025){kind=link}
The new version of the Variations Regulation (EU) 2024/1701 applies to post-authorisation variation applications for centrally authorised regulatory dossiers submitted to the authorities as of 1 January 2025. The aim of the new regulation, published in March 2024, is to make the life-cycle management of medicinal products for human use more efficient.
To help with the implementation of the new arrangements, the European Medicines Agency (EMA) has recently published a set of guidelines that specifically address the procedures for the various types of variations and the documents to be submitted (link to dedicated page). The European Commission’s examination of proposed amendments to the guidelines on the categories of variations and related procedures is also continuing, and is expected to be concluded in 2025.
Until this new legislation comes into force, the EMA website specifies, AIC holders should continue to refer to the current classification and guidance documents published at the end of October 2024 and available on the EMA website. For variations filed before 1 January 2025 , however, the provisions of Regulation (EC) 1234/2008 as amended by Delegated Regulation (EU) 2021/756 continue to apply.
Guidelines available on the EMA website
The EMA website page allows you to download the guidelines for the different types of variations that will apply from 1 January next, together with models of the letters of intent.
The document on type IA variations specifies, for example, that variations of this type that do not require immediate notification should be collected and filed as a ‘type IA manual update’ within 12 months of the implementation date of the oldest variation.
Another guideline describes how several type IA/ IAIN variations referring to the same MA should be grouped within a single notification and sent to a single reference regulatory authority.
A Guideline on Variation Sharing is also available, which provides that the AIC holder must compulsorily follow the sharing procedure for the same Type IB and Type II variations or for the same group of variations affecting more than one AIC of the same holder in a single application.
Finally, the last guideline concerns recommendations on the procedures to be followed for unforeseen variations filed pursuant to Article 5 of Regulation (EC) 1234/2008