30 April 2012

EMA: VNeeS submissions to be 100% compliant to guideline by June 01, 2012

Since January 2010, the Agency has accepted electronic submissions for applications for veterinary medicinal products or MRLs. Such applications should be submitted in line with the Guideline on the specifications for provision of an electronic submission (e-submission) for a veterinary medicinal product (“e-submission guideline”). Taking into account that this procedure of submitting electronic dossiers was new and that both regulatory authorities and applicants had to adjust their internal procedures to comply with e-submission requirements, the Agency accepted up to now dossier submissions not fully in line with these requirements. The electronic submissions are sent as CD or DVD, particularly initial applications, but updates of dossiers and responses to list of questions or post-authorisation applications are often submitted via EudraLink/e-mail. These EudraLink/e-mail submissions are not always sent via a central address, which may cause delays or inconsistencies in archiving.

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