Judgment_paragraph 12 · Delfarma Sp. z o.o. v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (C-488/20)

12Article 24 of Regulation No 726/2004, as amended by Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 (OJ 2010 L 348, p. 1) (‘Regulation No 726/2004’) provides:1. The [EMA] shall, in collaboration with the Member States and the Commission, set up and maintain a database and data processing network (hereinafter the “Eudravigilance database”) to collate pharmacovigilance information regarding medicinal products authorised in the Union and to allow competent authorities to access that information simultaneously and to share it.The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.2. The [EMA] shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the Eudravigilance database, together with a timeframe for their implementation.…The Eudravigilance database shall be fully accessible to the competent authorities of the Member States and to the [EMA] and the Commission. It shall also be accessible to marketing authorisation holders to the extent necessary for them to comply with their pharmacovigilance obligations.The [EMA] shall ensure that healthcare professionals and the public have appropriate levels of access to the Eudravigilance database, while guaranteeing personal data protection. The [EMA] shall work together with all stakeholders, including research institutions, healthcare professionals, and patient and consumer organisations, in order to define the “appropriate level of access” for healthcare professionals and the public to the Eudravigilance database.The data held on the Eudravigilance database shall be made publicly accessible in an aggregated format together with an explanation of how to interpret the data.3. The [EMA] shall, in collaboration either with the marketing authorisation holder or with the Member State that submitted an individual suspected adverse reaction report to the Eudravigilance database, be responsible for operating procedures that ensure the quality and integrity of the information collected in the Eudravigilance database.4. Individual suspected adverse reaction reports and follow-ups submitted to the Eudravigilance database by marketing authorisation holders shall be transmitted electronically upon receipt to the competent authority of the Member State where the reaction occurred.’