Swissmedic - Applicant's consent for sharing risk assessments info

Inclusion of a new section 7.14 “Sharing information relating to risk assessments for nitrosamine impurities” for the purpose of obtaining the applicant’s consent.

7.14 Sharing information relating to risk assessments for nitrosamine impuritiesThe 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 ( Swissmedic is thus authorised to provide its evaluations1. The decision regarding an authorisation is made independently of any information sharing with Swissmedic.

IDRAC_287727_10-Jan-2023_Swissmedic Form_ New Authorisation of Human Medicinal Products HMV4 (ZL100_.pdf (895.7 KB)