EMA Fails to Follow Legislation and Its Own Policy, page-10

You're right Figaroo and I'm sorry if my use of language confused anyone. You've caused me to do a bit more research and whereas I am not the font of all European Law I believe I may have found the relevant legislation which has been breached by the EMA in this instance:

"REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL"

"AUTHORISATION AND SUPERVISION OF MEDICINAL PRODUCTS FOR HUMAN USE"

Under Article 6:
"3. The Agency shall ensure that the opinion of the Committee for Medicinal Products for Human Use is given within 210 days after receipt of a valid application."

The only outstanding question IMHO is the one raised by Cro as to whether the company requested a delay until February.

Rev