ARGH.GEN.120 Means of compliance

ALTERNATIVE MEANS OF COMPLIANCE

(a)The competent authority may use alternative means of compliance (AltMoC) to establish compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts.

(b)The competent authority should establish a system to consistently check that the AltMoC used by itself or by the GH organisations under its oversight comply with Regulation (EU) 2018/1139 and its delegated and implementing acts. That system should include procedures to limit, revoke or amend AltMoC if the competent authority finds that these do not comply with Regulation (EU) 2018/1139 and its delegated and implementing acts.

(c)The competent authority should evaluate the AltMoC proposed by GH organisations in accordance with point ORGH.GEN.120 of Commission Delegated Regulation (EU) 2025/20, by analysing the documentation provided and, if necessary, conducting an inspection of the organisations. When the competent authority finds that the AltMoC proposed by a GH organisation are in accordance with Regulation (EU) 2018/1139 and its delegated and implementing acts, it should inform the Agency of their content, including copies of the relevant documentation.

(d)If the competent authority itself uses AltMoC to achieve compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts, it should:

(1)conduct a safety risk assessment of the AltMoC, which should demonstrate that compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts is met;

(2)make the AltMoC available to the GH organisations under its oversight if those AltMoC are intended for use by GH organisations;

(3)notify the Agency without undue delay; and

(4)provide the Agency with:

(i)a full description of the AltMoC, including any revision to manuals or procedures that may be relevant; and

(ii)the safety risk assessment referred to in point (1).

(e)AltMoC used by a competent authority or by a GH organisation under its oversight may be used by other competent authorities or GH organisations. However, they should be processed again in accordance with point (c) or (d), as applicable.