1.

In order to prepare for the fulfilment of the tasks referred to in Articles 4 to 8, the Agency, shall: specify the procedures and criteria for establishing and reviewing the critical medicines lists; specify the methods of and criteria for the monitoring, data collection and reporting provided for in Articles 4, 7 and 8, with a basic minimum data set; develop streamlined IT monitoring and reporting systems, in coordination with the relevant national competent authorities, that facilitate interoperability with other existing IT systems and IT systems under development until the ESMP is fully functional, on the basis of data fields that are harmonised across Member States; establish the working party referred to in Article 3(6) and ensure that each Member State is represented on that working party; establish and maintain a list of single points of contact for marketing authorisation holders for all medicinal products authorised in the Union, through the database provided for in Article 57(1), point (l), of Regulation (EC) No 726/2004; specify the methods for the provision of recommendations referred to in Article 5(2) and Article 8(3) and (4) and for the coordination of measures referred to in Article 8(5); publish information covered by points (a), (b) and (f) on a dedicated webpage on its web portal. For the purposes of the first subparagraph, point (a), Member States, marketing authorisation holders, other relevant actors in the supply chain for medicinal products and representatives of healthcare professionals, of patients and consumers, may be consulted as necessary.

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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.