Regulation (EU) 2019/897
(a) The applicant shall submit to the Agency the following documents:
1. a certification programme for the ETSO authorisation, setting out the means to demonstrate compliance with point 21.A.606(b);
2. a statement of compliance certifying that the applicant has met the requirements of this Subpart;
3. a declaration of design and performance (DDP), stating that the applicant has demonstrated that the article complies with the applicable ETSO in accordance with the certification programme;
4. a copy of the technical data required in the applicable ETSO;
5. the exposition, or a reference to the exposition, referred to in point 21.A.143 for the purpose of obtaining an appropriate production organisation approval under Subpart G or the manual, or a reference to the manual, referred to in point 21.A.125A(b) for the purpose of manufacturing under Subpart F without production organisation approval;
6. for an APU, the handbook, or a reference to the handbook, referred to in point 21.A.243 for the purpose of obtaining an appropriate design organisation approval under Subpart J;
7. for all other articles, the procedures, or a reference to the procedures, referred to in point 21.A.602B(b)(2);
(b) The applicant shall report to the Agency any difficulty or event encountered during the approval process that may significantly impact the ETSO authorisation.
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