ARA.GEN.120 Means of compliance

(a)The Agency shall develop Acceptable Means of Compliance (AMC) that may be used to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules. When the AMC are complied with, the related requirements of the Implementing Rules are met.

(b)Alternative means of compliance may be used to establish compliance with the Implementing Rules.

(c)The competent authority shall establish a system to consistently evaluate that all alternative means of compliance used by itself or by organisations and persons under its oversight allow the establishment of compliance with Regulation (EC) No 216/2008 and its Implementing Rules.

(d)The competent authority shall evaluate all alternative means of compliance proposed by an organisation in accordance with ORA.GEN.120 by analysing the documentation provided and, if considered necessary, conducting an inspection of the organisation. When the competent authority finds that the alternative means of compliance are in accordance with the Implementing Rules, it shall without undue delay:

(1)notify the applicant that the alternative means of compliance may be implemented and, if applicable, amend the approval or certificate of the applicant accordingly; and

(2)notify the Agency of their content, including copies of all relevant documentation;

(3)inform other MS about alternative means of compliance that were accepted.

(e)When the competent authority itself uses alternative means of compliance to achieve compliance with Regulation (EC) No 216/2008 and its Implementing Rules it shall:

(1)make them available to all organisations and persons under its oversight; and

(2)without undue delay notify the Agency. The competent authority shall provide the Agency with a full description of the alternative means of compliance, including any revisions to procedures that may be relevant, as well as an assessment demonstrating that the Implementing Rules are met.