ema - response to query - finally!

I sent this message to EMA on the 28th of November, 2012:

"My query is in relation to the letter of intention to submit. The guidelines suggest that the letter needs to be provided at least 6 months before the date of submission. However, I note that there has been some discussion of this point by EMEA committees. Can you please provide advice concerning the 6 months timeframe and the degreee of flexibility contained therein. For example is it possible to make the actual submission immediately or does EMEA require some warning in order to set up certain administrative processes? Furthermore, if the latter is the case and the notified body indicates it would like to make the submission ASAP, then will EMEA contact the notified body to set a date of submission."

Here is the response recevied today (15/2/13):

"Thank you for contacting the European Medicines Agency. Please accept our sincere apologies fro the delay in response.
With regards to your query, please note the timeframe 6/7 Months prior to submission mentioned on EMA Pre-submission (PS) guidance document is to enable Rapporteur appointment, to hold a pre-submission meeting with EMA. The latter is highly recommended, especially if the applicant (here the Notified Body) is not familiarised with the centralised evaluation."

Doesn't really answer the question and took a very long time to get it but given we're about two thirds of the way through the 6 months and we may well hear something concrete after next week's meeting, the answer is pretty academic anyway.

Rev