1.Within one month from the date of receipt of the pre-engagement application the authorising entity and the concerned NSAs for the area of use shall inform the applicant that the pre-engagement file is complete or ask for the relevant supplementary information, setting a reasonable deadline for the provision thereof.
2.Where the applicant is informed that their file is complete, the authorising entity and the concerned NSAs for the area of use shall issue through the one-stop shop an opinion on the approach proposed by the applicant in the pre-engagement application no later than two months after the acknowledgement that the file is complete. That issued opinion establishes the pre-engagement baseline, including a determination of the version of the TSIs and national rules that are to be applied for the subsequent application for authorisation without prejudice to paragraph 4.
3.The pre-engagement baseline shall specify which language shall be used pursuant to Article 10.
4.In case of changes affecting the pre-engagement file which are relevant for the pre-engagement baseline, the applicant shall send an amended and updated pre-engagement application only considering the changes and the interfaces with the unchanged parts. This may occur in the following situations:
(a)changes to the design or to the assessment methodology resulting from major safety issues;
(b)changes in legal requirements invalidating the pre-engagement baseline; or
(c)any changes voluntarily introduced by the applicant.
5.The authorising entity and where applicable the concerned NSAs for the area of use shall within 1 month review and issue an opinion on the amended and updated pre-engagement application and record that opinion in an amended and updated pre-engagement baseline.