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  • 1.  Marketing Authorization for OTC homeopathic in Europe

    This message was posted by a user wishing to remain anonymous
    Posted 29-Sep-2017 15:44
    This message was posted by a user wishing to remain anonymous

    Hi, I am new to RAPS and was wondering if anyone here has marketed an OTC homeopathic from the USA in Europe? I am not clear on the regulatory procedures and requirements to gain marketing authorization. There appears to be a few systems in place to do this but I haven't found much information regarding homeopathic drugs. Any help would be great!


  • 2.  RE: Marketing Authorization for OTC homeopathic in Europe

    Posted 30-Sep-2017 13:49
    Start with these two documents and you will need to contact EMA since Homeopathic medicines are a bit of a gray zone when importing into the EU.

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    Robert Falcone
    Lipo Chemicals
    Paterson NJ
    United States
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    Attachment(s)

    pdf
    report_on_emea_fuer_23-mai_2007.pdf   93 KB 1 version
    pdf
    D18-2015-Profile-of-an-industry.pdf   1.19 MB 1 version
    Original Message


  • 3.  RE: Marketing Authorization for OTC homeopathic in Europe

    This message was posted by a user wishing to remain anonymous
    Posted 02-Oct-2017 13:57
    This message was posted by a user wishing to remain anonymous

    Thanks! I will take a look at these.
    Original Message


  • 4.  RE: Marketing Authorization for OTC homeopathic in Europe

    Posted 02-Oct-2017 15:28
    The Homeopathic Medicinal Products Working Group (HMPWG) provides useful information, and guidelines on the regulations applicable to Homeopathic drugs.

    http://www.hma.eu/hmpwg.html

    ------------------------------
    Chitra Edwin PhD RAC
    Senior Vice President, Regulatory Affairs & Compliance
    Spotlight Innovation, Inc
    Towson MD
    United States
    ------------------------------

    Original Message


  • 5.  RE: Marketing Authorization for OTC homeopathic in Europe

    Posted 01-Oct-2017 07:07
    You'll find lots of information about registration of homeopathics by googling 'guidelines homeopathic medicinal products europe'.  The Irish Guide to registration is particularly useful https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0037-guide-to-registration-of-homeopathic-medicinal-products-v4.pdf?sfvrsn=6
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    Apart from the quality Module 3 file, There are plenty of specific requirements which you will need to consider such as the appointment of Qualified Persons for product release and pharmacovigilance, location of the applicant, need to perform readability testing on the package insert and Module 1.  A good EU consultant can help with these matters.
    Regards,
    Steve

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    Steve Binysh
    Acta Pharma Services Ltd
    RUISLIP
    United Kingdom
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    Original Message


  • 6.  RE: Marketing Authorization for OTC homeopathic in Europe

    This message was posted by a user wishing to remain anonymous
    Posted 02-Oct-2017 13:57
    This message was posted by a user wishing to remain anonymous

    Thank you, looks like I've got lots to read!
    Original Message


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