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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance article 82 CELEX: 02014R0536-20221205 Functionality of the EU portal and the EU database
1. The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the EU portal and the EU database, together with the time frame for their implementation. 2. The Management Board of the Agency shall, on the basis of an independent audit report, inform the Commission when it has verified that the EU portal and the EU database have achieved full functionality and the systems meet the functional specifications drawn up pursuant to paragraph 1. 3. The Commission shall, when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union. |