Guidance document Authorisation according to Art. 14 para. 1 abis-quater of the Therapeutic Products Act (TPA) updated
2 September 2022 – Swissmedic clarified the inclusion of safety-relevant aspects in the information for healthcare professionals for authorisations according to Art. 14 para. 1 lit. abis TPA. In addition, Art. 14 para.1 lit. aquater TPA requires that the existing cantonal registration be waived before the medicinal produced is launched on the market for the first time. The revised guidance document is valid with effect from 1 September 2022.
For more information, see here.