Changes regarding transfer of marketing authorisation and change to name or address of marketing authorisation holder
Following a redistribution of tasks between the Authorisations and Marketing sectors, Swissmedic wishes to inform marketing authorisation holders that the current guidance document regarding transfer of marketing authorisation and change to name or address of marketing authorisation holder (I-311.AA.04-A16d) will be replaced by two new guidance documents as of 1 September 2016.
The Authorisations sector (BW) will continue to handle changes to names or addresses of marketing authorisation holder. The relevant instructions are set out in guidance document BW303_00_001d_WL Change to name or address of marketing authorisation holder.
The Marketing sector (ZL) will process transfers of marketing authorisation between two authorisation holders in accordance with the detailed instructions set out in guidance document ZL303_00_001d_WL Transfer of marketing authorisation.
These new guidance documents will become available on the Swissmedic website during August 2016. Requests submitted as of 1 September 2016 will have to comply with the new instructions. Requests submitted before this date will be handled according to the current procedure.