Oral explanation to be held on Wednesday 25 March 2015 at 11.00, page-39

Fellow TIS holders,

Was looking at the EMA Centralised Procedure  February 2010 and in particular Page 8
"Basic New Product Assessment Process"
as it shows a diagram First Phase/Second Phase.

It highlights "Oral Explanation by the Applicant at Day 180" and this follows "List of Issues" stage of the process.

The interesting thing is that the next step is "Final Scientific Opinion, Report Day 210" followed by SPC, EPAR (Public Report) Etc.

The link is below and I think this is "positive"  IMO.


http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2010/03/WC500074885.pdf

GLTA