Attention of Marketing Authorisation Holders
The National Agency for Medicines and Medical Devices hereby reminds you the 2 dedicated addresses related to management of variations to marketing authorisation submitted for evaluation through European procedures, as follows:
var.responses@anm.ro – for submission of documentation/supplementations to documentation/responses concerning variation procedures in progress
var.translations@anm.ro – for submission of Romanian versions of texts agreed on positive completion of a variation.
You are reminded that intermediary versions of Product information (Summary of Product Characteristics, Leaflet, Labelling information) submitted in response to comments during the procedure are considered documentation and are transmitted to the address dedicated to this type of documentation. In addition, information may be required at the mrp-dcp.info@anm.ro general address regarding the NAMMD allocatted number to grouped variations for procedures with Romania as reference Member State.