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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 21 CELEX: 02014R0536-20221205 Substantial modification of aspects covered by Parts I and II of the assessment report
1. Where a substantial modification relates to aspects covered by Parts I and II of the assessment report, the application for authorisation of that substantial modification shall be validated in accordance with Article 17. 2. The aspects covered by Part I of the assessment report shall be assessed in accordance with Article 18 and the aspects covered by Part II of the assessment report shall be assessed in accordance with Article 22. |