rec_21

Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance) · European Union

(21) In the event that the actual future demand is unknown due to a public health emergency or major event, it is important to make pragmatic predictions as to demand for certain medicinal products on the basis of the best available information. In that context, information and data on available stocks and planned minimum stocks should be collected by Member States and the Agency and taken into account in identifying the demand as far as possible. Those information and data are essential for making correct adjustments in the manufacturing of medicinal products to avoid or at least mitigate the impact of shortages of medicinal products. However, when data on stocks are not available or cannot be provided due to national security interests, Member States should provide the Agency with estimated data on volumes of demand.

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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.