1.   Upon completion of an investigation of potential infringements listed in Article 42(1), point (a), of Regulation (EU) 2016/1011, and before submitting a file to ESMA, the investigation officer as referred to in Article 48i(1) of that Regulation, shall inform the person subject to investigation in writing of its findings and shall provide that person with the opportunity to make written submissions pursuant to paragraph 3. The statement of findings shall set out the facts liable to constitute one or more of the infringements of the requirements set out in Title VI of Regulation (EU) 2016/1011, including an assessment of the nature and seriousness of those infringements, taking into account the criteria laid down in Article 48e(2) of that Regulation.

2.   The statement of findings shall set a reasonable time limit for the person subject to investigation to make its written submissions. In investigations other than those referred to in Article 5, this time limit shall be at least four weeks. The investigation officer shall not be obliged to take into account a written submissions received after that time limit has expired.

3.   In its written submissions, the person subject to investigation may set out the facts, which it considers relevant for its defence and shall, if possible, attach documents as proof of the facts set out. The person subject to investigation may propose that the investigation officer hears other persons who may corroborate the facts set out in the submissions of the person subject to investigation.

4.   The investigation officer may invite a person subject to investigation to which a statement of findings has been addressed to attend an oral hearing. The person subject to investigation may be assisted by a counsel of their choice. Oral hearings shall not be public.