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Apostilling ISO Certificate and EC Certificate

  • 1.  Apostilling ISO Certificate and EC Certificate

    This message was posted by a user wishing to remain anonymous
    Posted 21-Jun-2022 16:45
    This message was posted by a user wishing to remain anonymous

    Hi community,

    I am really new to my regulatory role and I am asked to apostille our ISO and EC Certificate from TUV-SUD Germany to be submitted to Kazakhstan. My question is do I need to notarized the certificates first and then have it apostilled in the state if it was issued by TUV Germany? Or can I have it apostilled directly from the US Department of State?


  • 2.  RE: Apostilling ISO Certificate and EC Certificate

    Posted 22-Jun-2022 01:21
    Well, I am actually currently investigation the issue one step further with the authorities (no answers yet). My question is:
    • My Notified Body is accredited to issue certificates
    • I have a certificate from them
    • Why would I need a legal statement saying
      • the person signing the certificate is authorized to do so and
      • this statement is notarized?
    In my opinion this defeats the whole idea of official certificates.

    Can someone from the legal standpoint help us here please?

    Thank you so much.

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    Richard Jansky
    Head of RA / RM / QM
    Beringen
    Switzerland
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  • 3.  RE: Apostilling ISO Certificate and EC Certificate

    Posted 22-Jun-2022 03:19
    When we have a document apostille for Kazakhstan, we take it to the solicitors where they notarize that it is a "true copy" of the original document (CE Cert or DofC), then they send to the Kazakhstan embassy to have it apostille. We usually request for them to ship directly to the requestor and send a scan copy to us for our records.

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    Colleen Powell
    Director of Regulatory Affairs
    Gloucestershire
    United Kingdom
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  • 4.  RE: Apostilling ISO Certificate and EC Certificate

    Posted 22-Jun-2022 03:36
    Hello,

    At Richard: because some countries are stuck in the 1800s and do not trust anything or anyone?  Though in seriousness, these are needed because unfortunately there are a lot of ISO certificates (in particular ISO 9001) and other "certificates" which are falsified.

    The way Colleen described the process is probably the best approach.  You can have your local government apostille the document, but having the receiving country embassy apostille is a bit better.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 5.  RE: Apostilling ISO Certificate and EC Certificate

    Posted 22-Jun-2022 04:43
    Thank you, Richard, for your eye opener!

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    Richard Jansky
    Head of RA / RM / QM
    Beringen
    Switzerland
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  • 6.  RE: Apostilling ISO Certificate and EC Certificate

    Posted 23-Jun-2022 11:42
    Some countries require batch release documents for vaccines to be notarized for each batch of vaccine being received by them. This may include Lot Release certificates issued by Health authorities and electronically signed off documents issued from manufacturer's internal validated electronic systems. Some countries also request for wet signatures. Painful and expensive...unfortunately to prevent counterfeit practices.....

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    [Meena] [Garg] [Dr.]
    [Director]
    [InxSys BioSolutions Consulting]
    [Ontario]
    Canada
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  • 7.  RE: Apostilling ISO Certificate and EC Certificate

    Posted 22-Jun-2022 06:07
    Anon,
    I complete about 20 apostilles annual here in Michigan via the Secretary of State.

    For each document that needs legalization (apostille), if I have created it, I go to my notary with the document(s) and my identification and I sign the document (in the presence of the notary) and the Notary stamps, signs and dates document itself.

    However, if I am having document(s) notarized that I did not create, I need to create another document that I verify the authenticity of the document (certification, license or other document created by a third party) that requires the apostille. I sign the verification and the Notary stamps, signs and dates the verification document itself. 

    After my document is notarized, I take it to the state agency that is authorized to affix the apostille (here the Secretary of State) and that person takes my document and my identification and prepares the apostille and the bows or ribbons and the seal. 

    The completed apostilled document(s) are shipped to the requestor. No copies.

    Never break the seal on the Apostille. If for any reason the completed apostille seal is broken, redo the above.

    Yes, you need to have the document(s) notarized.

    Good luck.


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    Robert J. Bard, JD, RAC CQE
    Managing Director
    HealthCare Technologies Consultants, LLC
    Northville, MI
    USA
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  • 8.  RE: Apostilling ISO Certificate and EC Certificate

    Posted 22-Jun-2022 07:19
    You also need to be aware of what countries belong to the Hague convention and ones that don't. Some won't accept the Secretary of State.  The links to the website and pdf are pretty self explanatory. 

    https://www.hcch.net/en/states/hcch-members

    https://assets.hcch.net/docs/b697a1f1-13be-47a0-ab7e-96fcb750ed29.pdf

    ------------------------------
    Colleen Powell
    Director of Regulatory Affairs
    Gloucestershire
    United Kingdom
    ------------------------------



  • 9.  RE: Apostilling ISO Certificate and EC Certificate

    Posted 22-Jun-2022 07:18
    Welcome to Regulatory!  I hope you are enjoying your new role.  The notary stamp is the first step in document legalization process.   This website may be helpful for you to better understand the process.  Some countries also require the Seal of the Secretary of State for the state where you are located.  Good luck!   Apostille Requirements
    State remove preview
    Apostille Requirements
    Apostilles authenticate the seals and signatures of officials on public documents such as birth certificates, court orders, or any other document issued by a federal agency or certified by an American or foreign consul. An apostille certifies the document(s), so the document can be recognized in foreign countries that are members of the 1961 Hague Convention Treaty.
    View this on State >


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    Sara Coon
    Director, Regulatory Affairs
    MN United States
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  • 10.  RE: Apostilling ISO Certificate and EC Certificate

    Posted 22-Jun-2022 16:18
    It has been several years since I had to do this. We always used a service for Apostile and legalization by an embassy (when required).  You don't have to have anything done in Germany. I can speak to what we did in Ohio. We would create a cover sheet for the ISO and EC Cert copies that declared they were  exact copies of the orignial documents issued by [insert name of issuer] and sign in front of a notary. We never sent original certificates and never had issue with using notarized copies. Even if you sent the originals you would need to have the document notarized first. The Apostile is certifying that notary. I don't know how it works in other states, but believe it works the same as Ohio... If your notary is commissioned through the county you have to have the documents certified by the clerk of court in the county where the notary is commissioned and then certified by the secretary of state in the state where the document was notarized. If the notary was commissioned by the state then you only have to get the certification from the secretary of state. Then onto the US secretary of state for certification. If the country you are sending it to isn't part of the Hague Convention then you will need to have it legalized by the receiving country's embassy. This is a lot of sending out the documents and receiving them back to send out for the next step. The use if a service is key. They can also talk you through what you need for each country since there can be differences. 


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    Christine Anderson
    Senior Principal Specialist
    Cleveland, OH USA
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  • 11.  RE: Apostilling ISO Certificate and EC Certificate

    Posted 24-Jun-2022 20:23
    Hello!
    I've always recieved docs for Kazakhstan apostilled  many times in different companies. Normally it was done by my collegues at the Notary office. I believe Robert Bard described the process correctly. We only had to ask Embassies (Russian or KZ) in China for apostillation, so it usually took longer.
    Kazakhstan requires certificates to be apostilled, yes. Exception was when there was Covid-19 pandemic - they took e-copies from me for a while. They will require them apostilled in the future as well.)

    Oksana


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    Oksana Kolosova
    Moscow
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