Clarification of safety-relevant updates to medicinal product information for authorisations according to Art. 14 para. 1 let. abis TPA. Addition concerning the discontinuation of cantonal authorisation for authorisation according to Art. 14 para. 1 let. aquater TPA.
Based on accumulated experience, Swissmedic has clarified the inclusion of safety-relevant aspects in the information for healthcare professionals for authorisations according to Art. 14 para. 1 let. abis TPA (sections 6.4.2 and 6.4.4).
In addition, the requirement of discontinuation of existing cantonal registration before the medicinal product is launched on the market has been incorporated for authorisations according to Art. 14 para.1 let. aquater TPA (section 8.4).
The revised guidance document is valid with effect from 1 September 2022.