The section "Human Medicines - EMEA Post-Authorisation Guidance" comprises
an updated version of the Q&A guidance on variations. Some of the Q&As
related to variations Type 1 and Type 2 were revised in June 2007. Further
parts of this Post Authorisation Guidance were added in August.
In addition to the Q&As related to variations other parts of this document
provide answers to fundamental questions with regard to the authorisation of
medicines. A new part published in August is related to Article 61 (3)
"Notifications, Marketing and Cessation Notification".
Another interesting part, already published for some time, is the last
section entitled "Other". In addition to others it also contains the
question "Which EMEA inspection related activities may occur during the