02.02.2015 - The table Documents to be submitted has been modified. In the sheet “App. var. auth. Holder Var req.” app/sc. ass. has been modified to Var req. app/no sc. ass.; at the module 188.8.131.52 Manufacturing licence (M) has been removed and has been inserted at the module 2-5 in the new section “proof that a holder of an authorisation has an establishment licence according to art. 10, para. 1, letter b TPA (copy of the current establishment licence)”.