Renewal of authorisation for medicinal products whose authorisation expired as of 1 January 2020


For applications requesting renewal of authorisation which are to be submitted from July 2019 onwards (i.e. expiry of authorisation in the year 2020), variation A.109 for adaptation to the revised Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the Licensing Requirements for Therapeutic Products (SR 812.212.22; as at 1 January 2019) must be submitted as a separate application either before or, at the latest, at the same time as the application for renewal. If variation A.109 is not submitted, the applicant will be required to provide variation A.109 with the preliminary decision of the extension for the official decision concerning the renewal at a later date.