1. For the duration of a public health emergency, the sponsors of clinical trials conducted in the Union shall, in particular, make the following information publicly available through the EU portal and EU database established respectively by Articles 80 and 81 of Regulation (EU) No 536/2014:
(a)
the clinical trial protocol, at the start of each trial for all trials authorised under Regulation (EU) No 536/2014 that examine medicinal products which have the potential to address the public health emergency;
(b)
the summary of the results, within a timeline set by the Agency that is shorter than the timeline laid down in Article 37 of Regulation (EU) No 536/2014.
2. Where a medicinal product of relevance to the public health emergency receives a marketing authorisation, the Agency shall publish, in particular:
(a)
the product information with details of the conditions of use at the time of the marketing authorisation;
(b)
the European Public Assessment Reports as soon as possible and, where possible, within seven days of the marketing authorisation;
(c)
the clinical data submitted to the Agency in support of the application, where possible within two months of the marketing authorisation by the Commission;
(d)
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.