The suspension of the establishment licence and medicinal product authorisations of Dr. Heinz Welti AG became legally enforceable on 8 December 2022. This meant that authorised medicinal products under the name of Dr. Heinz Welti AG could no longer be distributed. Following successful implementation of corrective measures by the company, 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 GMP deficiencies identified in an inspection are remedied.
Swissmedic partially lifts suspensions for Dr. Heinz Welti AG: Distribution licences and authorisations are valid again; manufacturing activities still suspended
Suspensions for medicinal product authorisations lifted
31.03.2023
Dr. Heinz Welti AG has implemented initial corrective measures and taken appropriate actions to ensure compliance with the provisions of the therapeutic products legislation. Swissmedic is therefore lifting the suspension of the establishment licence for distribution activities at the Gebenstorf site with immediate effect. Consequently, all medicinal products registered in the name of Dr. Heinz Welti AG with valid authorisations that were manufactured and technically released before the suspension was applied in December 2022 can now be distributed again. The manufacturing licence for the Gebenstorf site and all activities at the Bubendorf site will remain suspended for the time being, until the deficiencies concerning compliance with good manufacturing practice (GMP) identified during an inspection are remedied.
Supplementary information
13.01.2023
Suspension of the establishment licences of Amino AG and Dr. Heinz Welti AG
Information for professionals, updating the communication dated 14 December 2022 on key aspects connected with the suspension of the establishment licences and authorisations of the companies Amino AG and Dr. Heinz Welti AG