Dear authorisation holder,
You will be aware that following renewal of approval for the ‘AIR4’ active substances[i], the process of Article 43 (the renewal of authorisations for all products containing those active substances) has started.
To help the Central Zone member states to plan for the expected workloads, we ask all affected authorisation holders to provide some information to facilitate co-operative working between member states. With the current e-mail we ask information on products based on AIR 4 active substances group 1-3.
Attached to this e-mail you will find a spreadsheet. Please note that based on the current status of the Brexit it is not possible to propose UK as ZRMS for products based on AIR 4 active substances. Please note that the spreadsheet does not need to be filled for products only authorized in UK.
Please note: an instruction is included in the spreadsheet!
You are kindly requested to return the completed spreadsheet by 15 December 2018 to the secretariat of the Central Zone at PPP@Ctgb.nl.
Mgr. Peter Kiklica
[i] Active substances as listed in Regulation (EU) N°2016/183