EMA/HMA/ECA: List of Active Substances defined to prevent supply bottlenecks

Recommendation

14-16 May 2024
Vienna, Austria

Analytical Instrument Qualification
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory

As part of the measurements against supply shortages in the pharmaceutical sector, the first version of the "Union list of critical medicines" and further information was published on the EMA website at the end of last year. This list contains more than 200 active substances that are considered critical in the event of a supply shortage and whose shortage must be avoided at all costs. These substances were chosen by all EU member states from a selection of 600 substances, and it is already clear that the list will be expanded in 2024. Currently, the substances on the list are categorised according to their "ATC description" (Anatomical Therapeutic Chemical code) and belong to a wide range of active substances including vaccines.

The Q&A document "Questions and answers on the Union list of critical medicines" provides further information on the list of active substances. In 19 questions and answers, it explains, for example, what obligations the list entails for marketing authorisation holders, what significance the list has for patients, suppliers or doctors and how the list should be used and understood.

Both the "Union list of critical medicines" and the "Questions and answers on the Union list of critical medicines" can be viewed on the EMA website.