Adaptation of the Guidance document Packaging for human medicinal products HMV4


Section 6.23: Reformulation of instruction “Please read the package leaflet”; Section 6.6: Clarification of information regarding dosage strength for parenterals in freeze-dried form;
Addition to section 9.3: Hospital packaging;
Addition to section 11.3.1: Application type A.100, type IAIN

The modified guidance document takes immediate effect.