Information for marketing authorisation holders

Information for marketing authorisation holders

The State Agency of Medicines informs that from now the product information (summary of product characteristics, package leaflet and labeling text) in the Medicinal Product Register on SAM website will be published in Word format that will facilitate its use for marketing authorisation holders. Product information in Word format will be available from March 5, 2014, starting with medicinal products included in the Order Regarding Marketing Authorisation of Medicinal Products No 2-20/20 (05.03.2014.). The format of documents published previously will not be changed.