Regulatory Open Forum

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  • 1.  EU Filling

    Posted 23-Oct-2013 11:14
    Hi, and thank you in advance for all feedback!

    I have no previous experience with EU Filings, does anyone know if paper filings are still the acceptable practice? If not, what is the current requirement?

    Thank you so much.

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    Kelsey Frisch
    Reliable Biopharmaceutical
    Overland MO
    United States
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  • 2.  RE:EU Filling

    Posted 24-Oct-2013 08:11
    Hello Kelsey, we have just sent our last CE marking dossier to our notified body. We agreed with them to send the dossier on a CD, so no paper copies. In the past we also used a shared FTP site.

    Best regards

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    Caterina Brusasco
    IBA
    Louvain La Neuve
    Belgium
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    Original Message


  • 3.  RE:EU Filling

    Posted 25-Oct-2013 04:00
    We recently submitted CE marking (Sept. 2013) and we only submitted electronic documents. 

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    Eugene Lee
    Taejoon Pharm
    Seoul
    Korea, Republic of
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    Original Message


  • 4.  RE:EU Filling

    Posted 31-Oct-2013 14:12
    Non -electronic filing in EU is being phased out in 2014 completely.

    http://www.raps.org/focus-online/news/news-article-view/article/3504

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    Rajeev Aneja
    Princeton NJ
    United States
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    Original Message


  • 5.  RE:EU Filling

    Posted 29-Oct-2013 02:27
    Please go through the following guidance published in the EMA website. The paper submission is still a legal requirement in some of the EU countries, not sure which countries still accept paper submissions though.

    http://esubmission.ema.europa.eu/doc/PAPER%20Accompanied%20by%20eCTD%20and%20NeeS%20Guidance%20Final%20March%202010.pdf

    Best luck,

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    Venkatesh Rao
    Senior Consultant, Regulatory Affairs
    India
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    Original Message


  • 6.  RE:EU Filling

    Posted 30-Oct-2013 10:35

    These are old guidelines. I think in EU- electronic is the preferred way.





    Original Message


  • 7.  RE:EU Filling

    Posted 31-Oct-2013 05:25
    Hi All,

    There is a new CESP system for electronic filing of submissions to European authorities, if we are talking medicines.  Suggest to have a look at that.  At present 27 countries particpating and being extended all the time.

    Kind regards

    Karen

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    Karen Real
    Director
    Real Regulatory Ltd
    London
    United Kingdom
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    Original Message