SAI - Legal mandate of the Refdata Foundation
“AIPS, professional and patient information”
According to Art. 67 para. 3, TPA, the marketing authorisation holder is obliged to submit the drug information in the version approved by Swissmedic, in the languages D/F/I, to the Refdata Foundation for publication, at the latest when the drug is first placed on the market (Art. 29 VAM/Ordinance on Medicinal Products).
The AIPS platform contains only product information approved by Swissmedic and uploaded by the marketing authorisation holder. The information can be accessed online or downloaded as XML files for further digital use.
“SAI, Structured information on medicinal products”
According to Art. 67 Para. 4, TPA, the marketing authorisation holder is obliged to publish the drug information in an electronic directory in structured form (SAI) for the public. To relieve the burden on the marketing authorisation holder, the Foundation makes use of approved and publicly available raw data from Swissmedic.
The marketing authorisation data presented in a structured way can be supplemented by the marketing authorisation holder with the GTIN and the trade status. The information can be accessed online or downloaded as XML files for further digital use.
The Refdata Foundation is a "non for profit" organisation and is tax exempt due to its "service public" commitment. For further information www.refdata.ch