2.

Where a medicinal product of relevance to the public health emergency receives a marketing authorisation, the Agency shall publish, in particular: the product information with details of the conditions of use at the time of the marketing authorisation; the European Public Assessment Reports as soon as possible and, where possible, within seven days of the marketing authorisation; the clinical data submitted to the Agency in support of the application, where possible within two months of the marketing authorisation by the Commission; the entire risk management plan referred to in Article 1, point 28c, of Directive 2001/83/EC, and any updated versions thereof. For the purposes of the first subparagraph, point (c), the Agency shall anonymise all personal data and redact commercially confidential information.

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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.