EMA Releases Guidance on Electronic Submission of Veterinary Applications
Posted 22 May 2012 | By
The European Medicines Agency (EMA) released a new question and answer guidance document on 22 May to assist sponsors with submitting their veterinary dossiers in an electronic format.
The document, Electronic submission of veterinary dossiers: Questions and answers, provides answers to a number of common questions.
Sponsors submitting via the centralized application procedure are encouraged-but not required-to submit their veterinary dossiers to EMA, though sponsors who have submitted electronic dossiers to EMA in the past are required to keep it updated electronically.
Unlike the application for human medicines, veterinary medicinal products do not use the electronic common technical document (eCTD), and submissions using the format will not be accepted by EMA.
All electronic applications for veterinary medicines in the EU can be submitted via EMA's eSubmission website. Sponsors also have the option of co-submitting physical copies of electronically-readable media to EMA so long as it is readable using software and hardware available to EMA.
Further information, including the labeling of electronic media, the use of encryption technologies in electronic media, and procedures to amend submissions is available in the guidance.
Electronic submission of veterinary dossiers: Questions and answers