Regulation amending procedures for examining variations of MA’s

The new regulation aims to simplify and streamline the existing legal framework, while ensuring the same level of public health protection, based on the practical experience and scientific and technical progress in the field of medicines.

The main changes introduced by the regulation include: the possibility to submit a single notification of variations to the terms of more than one marketing authorisation owned by the same holder ('super-grouping of variations'); the extension of the work-sharing procedure to cover all appropriate variations; the adaptation of the classification of some quality changes related to biological medicines to a risk-based approach; and the introduction of additional regulatory tools, such as post-approval change management protocols.

The Regulation also provides for specific procedures for variations concerning changes to the active substance of human influenza and coronavirus vaccines, as well as other human vaccines that have the potential to address a public health emergency, in order to ensure the continued effectiveness and availability of these vaccines.

The Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union and will apply from 1 January 2025, being binding in its entirety and directly applicable in all Member States.