Organisational approvals

Is the ETSO authorization holder required to hold organisational approvals?

An ETSOA holder could either hold a Product Organisation Approval (POA) or be linked through an agreement to an independent POA or produce under the provision of Part 21, subpart F.

The ETSOA holder is also required to hold Alternative Procedures to Design Organisation Approval (ADOA). For an APU approval a DOA is mandatory.

The organisational requirements do not apply to applications from third countries that have signed a full bilateral agreement with the EU.

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Can an ETSO Authorisation Holder task different production organisations for the production of articles covered by one ETSO Authorisation at the same time?

This is not allowed and is explained below. 
 
According to Part 21 subpart O, the ETSOA holder is responsible for the manufacturing of ETSO articles [see 21.A.602B(a), 21.A.607, 21.A.609(a)]. 
Considering the general provisions of 21.A.2, for those ETSOA holders that do not wish to manufacture, they have the possibility to have an agreement with another natural or legal person for the production of the article. In this case, only this other natural or legal person is allowed to manufacture the article and mark it accordingly. According to 21.A.2 an ESTO article cannot be produced by two different natural or legal person at the same time. 
Therefore the options are:

  • the ETSOA holder manufactures the article, or
  • the one natural or legal person with which the ETSOA holder has such agreement manufactures the article. 

For the one natural or legal person with which the ETSOA holder has such agreement the following has to be considered. In cases where Part 21 Section A Subpart G is applicable, such as to produce ETSO articles, a letter of agreement to produce under Part 21 Subpart F should not be given unless an application has been made for organisation approval under Subpart G, and reasonable progress is being made towards compliance with Subpart G. Long-term production under Part 21 Subpart F will not be permitted.

 

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Can an ETSO Authorisation Holder task different production organisations for the production of different articles covered by different ETSO Authorisations?

Yes, an ETSO Authorisation Holder can task different production organisations for the production of different articles covered by different ETSO Authorisations, as long as for each ETSO Authorisation only one production organisation is tasked.

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