The EMEA has revised the Q&A document in chapter V of Eudralex Vol 10.  The changes are as follows:

New question 3: is commercially available product used as a comparator IMP?  Answer is yes basically!

New Question 4: Definition of a non-interventional trial - to clarify that these are not subject to GCP.

Revised Question 8: This is about sponsor delegation of tasks and responsibilities and specifically states that the sponsor can delegate tasks/duties but remains RESPONSIBLE.

Revised question 18: Dates of annual safety reports can be aligned with PSURs and IND Annual Reports provided the timeframe is shortened rather than lengthened.