EMEA: Electronic-only submissions

As of 12 October 2009 (new procedures without pre-submission meeting) and 19 October 2009 (new procedures with Pre-submission meeting), the EMEA will only accept electronic submissions for Scientific Advice and Protocol Assistance final requests, including follow-up requests. Applicants should submit their applications as a CD or DVD only. As of 03 August 2009, the EMEA is only accepting electronic submissions for new Qualification of novel methodologies final requests. Applicants should submit their applications as a CD or DVD only.