In the attention of the applicants

Note

Please be informed that in the marketing authorisation granted in RO through decentralised/mutual recognition/repeat use procedures, the information regarding the name, address and function(s) of each manufacturer will be written in line with the information declared in the latest eAF submitted during the European procedure.

Therefore, the applicant is requested at all time to align the information from eAF regarding the name, address and functions for each manufacturer, with the correct information from Module 3.2.S, 3.2.P.3.1, Annex 5.6, Annex 5.8, Annex 5.9 and Annex 5.22. (Please refer to the User guide for the electronic application form for a Marketing Authorisation published by the CMDh).