Adaptation of the form Manufacturer information and new form Responsible Person Declaration


At the end of 2013, the form Manufacturer information was modified to make it easier for applicants to enter the manufacturer's details and to speed up Swissmedic's internal processes. The form has been completely revised in consultation with industry representatives in the light of the experience gained with this version, new requirements for the review process, an increase in the volume of queries and a more complicated eCTD life-cycle.

The new form Manufacturer information (version 7.0) will be available on the Swissmedic website in July 2016. The current version of the form (06) will still be accepted during a transitional period lasting until 30 November 2016.

At the same time a new form will be provided for RP declaration(s). This should be submitted with all changes and new applications.