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Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency (EMA) and to members of the Committee for Medicinal Products for Veterinary use (CVMP)

EMA: Electronic submission via the EMA e-Submission Gateway or Web Client is currently strongly encouraged and will become mandatory as of 1 January 2017.

Source: EMA Veterinary Medicines Division

Read the full dossier requirements at

Samarind RMS specialises in electronic submission of your regulatory affair documentation, contact us today for a demonstration of the product to see if we have a solution for your e-submission problems.


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