European Commission Started Consultations on Revision of Variation Framework for Medicines for Human Use
On 29 August 2023, the European Commission (the Commission) started public consultations on a revision of the variation framework for medicines for human use. This set of rules governs changes to an existing marketing authorisation for medicines. The Commission is probing for ways to achieve efficiency gains in hopes of reducing the administrative burden for both marketing authorisation holders and the regulatory authorities. Stakeholders will welcome efficiencies in the face of the large number of variations.
While the Pharmaceutical Package (see, Van Bael & Bellis Life Sciences News and Insights, 3 May 2023), once adopted, will bring about further improvements for managing post-authorisation changes, the Commission points out that it will still take “some years” for this set of rules to take effect. This makes a short-term approach necessary and will involve amendments to delegated Commission Regulation 1234/2008 which governs variations to the terms of marketing authorisations of medicines for both human and veterinary use, regardless of whether they are centrally authorised or form the subject of a national authorisation.
The Commission is considering re-classifying specific variations into lower categories; adding flexibility regarding the level of technical information that must be provided; clarifying the changes and data that must be communicated to the regulators; simplifying the single submission or notification of variations (“grouping”); and creating work-sharing procedures.