Revision of the Therapeutic Products Licensing Requirements Ordinance
7 July 2022 – Following the conclusion of the expert and official consultations, the Swissmedic Institute Council decided at its meeting on 22 April 2022 to amend Annex 7 of the Ordinance on the Authorisation of Medicinal Products (Arzneimittel-Zulassungsverordnung, AMZV) with effect from 1 July 2022. In addition to clarifications of conditions and documentation requirements, the current revision of Annex 7 TPLRO also includes a new quality change for Type II.
For more information, see here.