anx_I__cpt_2__point_12__text_1

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 · European Union

In the case of a resubmission, the cover letter shall specify the EU trial number for the previous clinical trial application, highlight the changes as compared to the previous submission and, if applicable, specify how any unresolved issues in the first submission have been addressed.

← 12. · All articles · C. EU APPLICATION FORM →

Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.