Changes to the medicinal product information as of 2019

From the 1^st of January 2019 onwards, the specific changes (type IA, IA_IN, IB, II or Marketing Authorisation extension) listed in Annex 7 AMZV (= Ordinance of the Swiss Agency for Therapeutic Products on the Requirements for the Authorisation of Medicinal Products) shall apply to variations in Switzerland; this also applies to any changes to the medicinal product information of a product. In terms of the fees to be charged, it is no longer relevant how many sections change or whether the Patient Information changes; only the type of variation (e.g. type IB or type II) is important. Only the new requirements as per the revised AMZV need to be implemented for A.109 changes. In addition to an A.109 change, other variations may, however, be submitted collectively within the framework of a collective application for the specific medicinal product. Safety-relevant changes may not, however, be included in collective applications.