The newly finalized Variations Regulation has been published in the Official Journal of the E.U., providing a framework for implementing post-authorization changes to medicinal products. Updates aim to streamline the variations process and align with current regulatory practices. A new guideline implementing the changes is open for public consultation until August 23, 2024.
The regulation distinguishes between minor Type IA variations like changes in manufacturing sites, Type IB variations such as alternative sterilization sites, and major Type II variations like introducing a new manufacturer for an active substance. The regulation applies to products with marketing authorizations according to Regulation (EC) No 726/2004 and Directive 2001/83/EC.
In 2020, the European Commission identified opportunities to improve the variations regulation, leading to a revised regulation in 2024. The Commission aims to reduce administrative burdens and costs for market authorization holders. Proposed changes include reclassification of variations, additional flexibility, and simplifying submission procedures.
The finalized implementing regulation was published in the Official Journal, with updates to the classification of changes for medical devices and in vitro diagnostics. The revised guideline for variations introduces clarifications based on current regulatory practices, restructuring sections to eliminate duplication, and adding new classifications for different types of variations.
The guideline emphasizes the importance of work-sharing procedures to reduce duplication of efforts for sponsors and regulators. Marketing authorization holders must ensure all affected authorizations are included in submissions, and timelines for assessment of variations are clarified. The guideline also addresses changes to the classification of variations and introduces new regulatory tools.
While the guideline is open for public consultation until August 23, 2024, it will not be applicable until the delegated regulation takes effect on January 1, 2025. The guideline does not address work-sharing with regulators outside the E.U., and industry may need to submit updates to international regulators separately. A second revision of the variations regulation is expected after the revised pharmaceutical legislation is implemented.
Overall, the Variations Regulation aims to streamline the post-authorization changes process for medicinal products, with the final guideline providing clarity on classification, submission requirements, work-sharing procedures, and timelines for assessment. The regulation and guideline updates reflect current regulatory practices and aim to reduce administrative burden for market authorization holders.
