The suspension of the establishment licences and medicinal product authorisations of Amino AG became legally enforceable on 8 December 2022. As a result, the manufacture of medicinal products was no longer possible and medicinal products under the name Amino AG could no longer be distributed. Subsequent to Swissmedic’s acceptance of the new Qualified Person (QP) at the end of January 2023 and the company’s implementation of measures for distribution in accordance with the regulations, Swissmedic is lifting the suspension of the establishment licence for distribution activities and of the medicinal product authorisations with immediate effect. The manufacturing licence remains suspended until the deficiencies identified in an inspection in August 2022 are remedied.
Swissmedic partially lifts suspensions for Amino AG: medicinal product authorisations are valid again, manufacturing activities still suspended
Interim decision concerning suspension of establishment licences and medicinal product authorisations of Amino AG
22.03.2023
Amino AG has implemented initial corrective measures and taken appropriate actions to enable medicinal products manufactured and released before 8 December 2022 to be distributed according to the regulations. The suspension of the establishment licence for distribution activities is therefore lifted with immediate effect. The medicinal product authorisations dependent on the establishment licence are valid again. The partial lifting of the suspension means that Amino AG is permitted to place on the market those of its authorised medicinal products that were manufactured and technically released before the suspension acquired legal force.
Because Swissmedic also identified significant deficiencies in compliance with Good Manufacturing Practice (GMP) in a routine inspection in August 2022, the manufacturing licence remains provisionally suspended. For the time being, Amino AG is not permitted to manufacture or technically release any medicinal products until these deficiencies are remedied and compliance with the provisions of therapeutic products legislation on the manufacture of medicinal products is ensured.
Supplementary information
Suspension of the establishment licences of Amino AG and Dr. Heinz Welti AG