art_13__para_6__point_b__text_1

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

require that data submitted to the ESMP comply with the standards developed by the International Organization for Standardization for the identification of medicinal products and be based on the domains of master data in pharmaceutical regulatory processes, namely substance, product, organisation, and referential data, where relevant;

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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.