MB Decision No 01-2023
1. The Agency may terminate an initial evaluation procedure when the applicant is unable or unwilling to demonstrate compliance with Part‑TCO as demonstrated by:
a. a lack of transparency or adequate and timely communication on the part of the applicant; or
b. an inappropriate or insufficient corrective action plan presented in response to findings.
2. If during an initial evaluation procedure the Agency determines that the number and/or nature of non-compliance findings of an applicant is such that permanent rectification of all level 1 findings within 3 months after their initial notification is unlikely or unrealistic, the Agency may decide to reject the application on grounds of significant systemic non-compliance with Part‑TCO in accordance with ART.200(e)(1).
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