The European Commission has published the decision (L275) in the Official Journal of the European Union, today (July 31, 2021) announcing that the EU portal and the EU database have achieved full functionality and meet the functional specifications, as referred to in Article 82(2) of Regulation (EU) No 536/2014. This Decision shall enter into force on the day of its publication in the Official Journal of the European Union (31 July 2021).
On 21 April 2021, the Management Board of the Agency, on the basis of the independent audit report delivered on 8 April 2021, informed the Commission in accordance with Article 82(2) of Regulation (EU) No 536/2014 that the EU portal and the EU database have achieved full functionality and the systems meet the functional specifications published by the Agency.
On the basis of the information provided by the Management Board of the Agency, the Commission verified that the EU portal and the EU database fulfilled the conditions of the full functionality and of compliance with those functional specifications. For more details, please refer to the Commission Decision (EU) 2021/1240 of 13 July 2021 on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council.