HPRA WEBINAR- 24 March 2026
Following the amendment of the Variation Regulation [(EU) 2024/1701 amending (EC) No 1234/2008) (hereafter the Variation Regulation) – applicable since 1 January 2025 – the European Commission (EC) has adopted and published an updated version of the EC variations guidelines 1 . The Guidelines apply from 15 January 2026.
To support stakeholders with national licenses authorised via a National or Mutual Recognition Procedure, the Health Products Regulatory Authority (HPRA) will be hosting a webinar where relevant aspects associated with the implementation of the revised guidelines will be discussed. In addition, the HPRA will present on other topics relevant to variations, such as commonly-seen issues associated with applications, as noted during the submission and assessment phases.
1 Guidelines on the details of the various categories of
variation, on the operation of the procedures laid down
in Chapters II, IIa, III and IV of Commission Regulation
(EC) No 1234/2008 concerning the examination of
variations to the terms of marketing authorisations for
medicinal products for human use, and on the
documentation to be submitted pursuant to those
procedures.
