7 July 2022
Revision of the Therapeutic Products Licensing Requirements Ordinance
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.
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