rec_20

(20) In order to facilitate the prevention, monitoring and reporting of shortages of medicinal products, the Agency should set up an information technology (IT) platform, to be known as the European shortages monitoring platform (‘ESMP’), that is capable of processing information on the supply of and demand for critical medicinal products during public health emergencies or major events and, outside of those situations, to allow for reporting on shortages of medicinal products that are likely to lead to public health emergencies or major events. To facilitate the development of the ESMP, existing IT systems should be leveraged and used where possible. The ESMP should allow national competent authorities to submit and monitor information on unmet demand, including information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public, in order to anticipate shortages of medicinal products. The ESMP could also process additional information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public in order to avert a public health emergency or a major event. The ESMP, once it is fully implemented, should act as the sole portal for marketing authorisation holders to provide the information required during public health emergencies and major events, with a view to increasing efficiency and predictability during public health emergencies and major events, and to accelerating the decision-making process while avoiding duplication of efforts and unjustified burdens on stakeholders. In order to facilitate the coordination role of the Agency, the interoperability of data with existing Member States’ IT platforms for monitoring shortages and other systems, as appropriate, is essential to allow the sharing of relevant information with the ESMP, which should be managed by the Agency.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.