Amino AG/Dr. Heinz Welti AG: Suspension of establishment licences and authorisations

Medicinal products that have already been delivered can still be distributed


On 1 October 2019, Swissmedic suspended the establishment licences and all medicinal product authorisations of Amino AG and Dr. Heinz Welti AG. Swissmedic waived a recall of goods already sold. This means that in accordance with the official decision, batches delivered by the two companies up until 8 December 2022 (date the suspension acquired legal force) can continue to be distributed and dispensed. A recall by the company would, however, be permitted.

Amino AG and Dr. Heinz Welti AG appealed unsuccessfully against the official decisions of suspension. The Swiss Federal Supreme Court issued a final rejection of the appeals on 29 November 2022 (published 7 December 2022). Since that time, Amino AG and Dr. Heinz Welti AG no longer hold valid licences under therapeutic products legislation and are no longer permitted to exercise activities governed by therapeutic products legislation. This will apply as long as the deficiencies that resulted in the suspension have not been remedied and until Swissmedic has officially lifted the suspension.