Regulation (EU) 2021/1963
(a) An application for a certificate or an amendment to an existing certificate in accordance with this Annex shall be made in a form and manner established by the competent authority, taking into account the applicable requirements of Annex I (Part-M), Annex Vb (Part-ML) and this Annex.
(b) Applicants for an initial certificate pursuant to this Annex shall provide the competent authority with:
1. the results of a pre-audit performed by the organisation against the applicable requirements provided for in Annex I (Part-M), Annex Vb (Part-ML) and this Annex;
2. documentation demonstrating how they will comply with the requirements established in this Regulation.
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