14.03.2013.
Dear clients! Submission of the electronic documentation in the non-eCTD (NeeS) format The State Agency of Medicines (hereinafter SAMLV) informs you that starting from March 18, 2013 there will be launched documentation in NeeS format uploading into SAMs database. In order to ensure positive technical validation, please take into consideration guidance for NeeS submissions for human medicinal products in the EU. Note, if technical validation is negative, you will be informed about invalidation issues via email during 5 days; if technical validation is positive – email will not be sent. Guidance for NeeS you can see here. For more information please visit EMA home page (PDF file). Read more.
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