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[RegAffairs]Re: Submitting US dossier to EU
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Title: Re: Submitting US dossier to
EU
This can be very complicated or, if you are remarkably lucky,
very easy. As there is presumably no requirement for a biostudy you
are already on the up side. You now have to work through the ANDA line
by line-for example-the API needs a European DMF and if there is a
monograph is must comply with the Ph. Eu.
Excipients are also a problem-the EMEA does not recognize USP as
a standard.
You should get someone to review your dossier who ha both Eu and
USA development background...that should be pretty quick and
easy...you will then know exactly where you are.
Malcolm Ross
Generapharm-Training and Consultancy
Basel-CH
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