Revision of the Therapeutic Products Licensing Requirements Ordinance

7 juillet 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.

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