Swiss Medic recently published a new version of their form for new marketing authorization. A new section has been added 7.14 “Sharing information relating to risk assessments for nitrosamine impurities” for the purpose of obtaining the applicant’s consent
The applicant consents to Swissmedic sharing evaluationsdrawn up by Swissmedic on nitrosamine impurities for a medicinal product with international partner authorities for the purpose of sharing information and as support for forming opinions as part of its collaboration in the Nitrosamine Strategic Group (NISG) and Nitrosamine Technical Working Group (NITWG). This exchange is based on the existing agreements (https://www.swissmedic.ch/swissmedic/information-exchange). Swissmedic is thus authorised to provide its evaluations1. The decision regarding an authorisation is made independently of any information sharing with Swissmedic.
Form attached: (English/French/German/Italian)
IDRAC_287727_05-Jul-2022_Swissmedic Form_ New Authorisation of Human Medicinal Products HMV4 (ZL100_.pdf (894.7 KB)