Finnish Medicines Agency Fimea maintains and promotes the safe use of medicines, healthcare equipment and supplies, and blood products. It is also responsible for publishing up-to-date information on medicinal products. Fimea chose Indox as its XML publishing system and OpenText Content Server as its knowledge management system.
Summary of Product Characteristics and Package Leaflet on Fimea's website
Medicines marketed in Finland must have a marketing authorization. Along with the marketing authorization application, the applicant must submit e.g. Summary of Product Characteristics and Package Leaflet. Once a marketing authorization has been granted, Fimea publishes the approved SPCs and package leaflets on its website via the Indox XML publishing system connected to the Content Server software. MS Word summaries are automatically converted to XML whenever they are exported to the Content Server document archive. Product summaries and their metadata in XML format are retrieved from the Content Server and transferred to the Indox XML publishing system using the Indox Content Server Interface piece.
Versatile search functions
There are many ways to search for published medicines; in addition to the name of the medicinal product, on the basis of the active substances, adverse reactions or ATC classification (anatomical-therapeutic-chemical classification) of the medicinal product. The product information can also be found in the Marketing Authorization Holder's name or marketing authorization number. Medicinal products that have been revoked are automatically removed from the system.
The search result contains a link to both the summary of product characteristics and the package leaflet in PDF format.