22 May 2012

RAPS: EMA Releases Guidance on Electronic Submission of Veterinary Applications

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.

To find more information please use the below mentioned weblink

http://www.raps.org/focus-online/news/news-article-view/article/1554/ema-releases-guidance-on-electronic-submission-of-veterinary-applications.aspx

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