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Acceptable Means of Compliance & Alternative Means of Compliance

Acceptable Means of Compliance & Alternative Means of Compliance. Margit Markus Moossen Legal department 31 January 2013. Overview. Introduction of AMC; Introduction of AltMoC ; AltMoC process : From the CA perspective; The Agency’s procedures ;. Acceptable Means of Compliance.

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Acceptable Means of Compliance & Alternative Means of Compliance

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  1. Acceptable Means of Compliance&Alternative Means of Compliance Margit Markus Moossen Legal department 31 January 2013

  2. Overview • Introduction of AMC; • Introduction of AltMoC; • AltMoCprocess: • From the CA perspective; • The Agency’sprocedures;

  3. Acceptable Means of Compliance • Legal basis: Article 18(c) of Regulation 216/2008; • Article 10 (1) of Regulation 748/2012; • Article 8(1) of Regulation 2042/2003; • ARA.GEN.120(a) of Annex VI to Regulation 1178/2011; • ARO.GEN.120(a) of Annex II to Regulation 965/2012; • Recital 7 of Regulation 805/2011; change via "view" > "header and footer"

  4. Art 18(c) of Basic Regulation • The Agency shall, where appropriate issue certification specifications and acceptable means of compliance […] for the application of this Regulation and its implementing rules. change via "view" > "header and footer"

  5. AMC- ARO.GEN.120(a) • The Agency shall develop acceptable means of compliance (AMC) that may be used to establish compliance with Regulation (EC) No 216/2008 and ist Implementing Rules. When the AMC are complied with, the related requirements of the Implementing Rules are met. change via "view" > "header and footer"

  6. AMC • ‚soft law‘- adopted by the ED; • non-binding; • not mandatory to use; • not to introduce new requirements or alleviate the requirements; • presumed compliance when following the AMC issued by the Agency; change via "view" > "header and footer"

  7. Alternative Means of Compliance • ARA.GEN.120(b): • Alternative means of compliance may be used to establish compliance with the Impementing Rules. change via "view" > "header and footer"

  8. ARA.GEN.105: • “Alternative means of compliance” are those that propose an alternative to an existing AMC or those that propose new means to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules for which no associated AMC have been adopted by the Agency; change via "view" > "header and footer"

  9. AltMOC: Principles AMC = Non-binding Alternative means may be used Compliance with rules demonstrated Process established to ensure: No negative effect on safety Transparency Harmonisation

  10. ORA.GEN.115 • Full description of AltMOC • Revisions to manuals or procedures • Demonstration that rules are complied with • Organisations may use AltMOC to establish compliance with rules • Implementation is subject to prior approval by CA:

  11. ARA.GEN.115 - 1 CA needs to have a system in place to consistently evaluate the compliance of AltMOC with the rules • For AltMOC proposed by organisations • For AltMOC it proposes itself

  12. ARA.GEN.115 - 2 CA evaluates AltMOC proposed: • Analysis of documentation provided & if needed inspection • Notify applicant & change of certificate, if needed • Notify the Agency of the content, including copies of relevant docs • Inform other MS When AltMOC complies with the rule, CA:

  13. ARA.GEN.115 - 3 CA proposes AltMOC itself • Makes them available to all organisations and persons under its oversight • Notifies the Agency • Full description of the AltMOC, including any revisions to procedures • Demonstration that AltMOC complies with rules

  14. The Agency process - 1 • Agency receives notification from CA Standardisation • Risk based approach Rulemaking • Recurrent task • Simplified procedure

  15. The Agency process - 2 Information included in database Quarterly review by S & R FP • Identification of significant AltMOC, requiring further assessment • Statistical report to S & R management

  16. The Agency process - 3 Input to S, for use in Standardisation Significant AltMOC reviewed by internal experts: • Compliance with rules • Regularity of procedure Input to R, for possible RM task

  17. Actions • Creation of a dedicated mailbox AltMOC@easa.europa.eu • Dedicated page on EASA website, with relevant information under development

  18. We would like your input • Any specific information you would like to see on the website? • The RAG has already indicated they would like to have: • A form for the notification • A list of contacts in the different CA, where you could send your notifications and queries • Do you have any further suggestions that would facilitate your work and our cooperation?

  19. Questions?Suggestions? Contact micaela.verissimo@easa.europa.eu

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