Conclusion of the assessment of the application
Article 45
1. The authorising entity shall ensure that the process for the assessment of the application has been carried out correctly by checking in an independent manner that: (a) the different stages of the process for the assessment of the application have been correctly applied; (b) there is sufficient evidence to show that all relevant aspects of the application have been assessed; (c) written responses to type 3 and 4 issues and requests for supplementary information have been received from the applicant; (d) type 3 and 4 issues were all resolved or where not resolved, together with clearly documented reasons; (e) the assessments and decisions taken are documented, fair and consistent; (f) the conclusions reached are based on the assessment files and reflect the assessment as a whole. 2. Where it is concluded that the process for the assessment of the application has been correctly applied, a confirmation of the correct application of paragraph 1, accompanied by any comments, shall suffice. 3. Where it is concluded that the process for the assessment of the application has not been correctly applied, then reasons for reaching that conclusion shall be clear and specific. 4. In conclusion of the assessment activities, the authorising entity shall complete an assessment file covering paragraphs 2 or 3 on the basis of the assessment files issued in accordance with Article 39(5) and Article 40(6). 5. The authorising entity shall provide documented reasons for its conclusion in the assessment file referred to in paragraph 4.