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GM1 ARGH.MGM.200 Management system

ED Decision 2025/006/R

ORGANISATION AND GENERAL POLICY

(a) It is recommended that the competent authority be organised in such a way that:

(1) there is specific and effective management authority in the conduct of all relevant activities;

(2) the functions and processes described in the applicable requirements of Regulation (EU) 2018/1139 and its implementing and delegated acts, AMC and GM can be properly implemented;

(3) the competent authority’s organisational and operating procedures for the implementation of the applicable requirements of Regulation (EU) 2018/1139 and its implementing and delegated acts are properly documented and applied;

(4) specific and effective provision is made for communication and coordination, as necessary, with the Agency and the competent authorities of other Member States; and

(5) all functions related to implementing the applicable requirements are adequately described.

(b) The competent authority’s general policy on activities to implement the applicable requirements of Regulation (EU) 2018/1139 and its implementing and delegated acts, while satisfying additional national regulatory responsibilities, takes into account in particular:

(1) the provisions of Regulation (EU) 2018/1139,

(2) the provisions of the applicable implementing and delegated acts and their AMC and GM,

(3) the needs of the industry, and

(4) the needs of the Agency and of the competent authority.

(c) The policy defines specific objectives for key elements of the organisation and processes for implementing related activities, including the corresponding control procedures and the measurement of the standard achieved.