The texts of the SPC, PIL and labelling forming part of any application handled after 2 April 2013 will no longer bear the “APPROVED” stamp and will no longer be labelled as annexes to the decision/notification. Instead, they will only be labelled with the reference number of the procedure in which they were handled.
Home
/
Medicines
/
Marketing authorisation of pharmaceuticals
/
Details of marketing authorisation
/
Questions and answers on the amended Act on...
/
General question
/
How will be product information (SPC, PIL,...