Recommendations for better identification of medicinal product information

Recommendations for better identification of medicinal product information

Information for marketing authorisation holders

Currently medicinal product information (summary of product characteristics, patient information leaflet, labelling text) available on the State Agency of Medicines (SAM) website could be identified by information placed on the upper edge of the page “Approved by the SAM dd.mm.yyyy.” However, representatives of the marketing authorization holders time by time requested to adjust published medicinal product information with the regard to specific marketing authorization, renewal or variation procedure.

In order to provide better link between published medicinal product information and specific marketing authorization, renewal or variation procedure, the State Agency of Medicines kindly asks marketing authorization holders to identify submitted product information by adding an appropriate reference in header or footer.

Example

Please be informed also that reference used by the company will be displayed unchanged in the medicinal product information published on the SAM website.