(2004; 109 pages)
Annex IV Licence Symbol, Swissmedic1
1 Swissmedic Internet communication 4 September, 2003 at http://www.swissmedic.ch/en/industrie/overall.asp?theme=0.00107.00004.00001&theme_id=916&news_id=1839&page=1
The licence symbol indicates that Swissmedic, the Swiss Agency for Therapeutic Products, has issued an authorization for a specific preparation. (It corresponds to the previous “IKS/OICM” including the (IKS/Uhu) logo in the corner with the distribution category.) Owing to the disbanding of Sanphar the previous “IKS Vignettes” may not be replaced with “Medwin Vignettes” and the old IKS logo will no longer be continued by Swissmedic. A new format for the licence symbol will therefore be made available to companies requiring it. It was decided that the all black version of the Swissmedic logo should appear in the circle indicating the distribution category. For reasons of space the authorization number had to be left out of this circle. On the packaging the authorization number is indicated under the EAN barcode. As this number is the only way of faultlessly classifying the package, the package indication in the form of a three-figure pharmaceutical code for IKS preparations or the two-figure pharmaceutical code for the former BAG preparations is printed in the EAN barcode next to the former five-figure IKS number or the former three-figure BAG number. However, as it is not legally compulsory to place a barcode on the package, in the absence of the EAN barcode the authorization number must be printed on the packaging, with the indication “Zulassungs-Nr.” (abbreviated to: “Zul.-Nr.”). The previous bilingual indication “IKS/OICM” or “BAG/OFSP” must of course be replaced by “SWISSMEDIC” (in capitals to make it easier to read). The time allowed for the change-over to the Swissmedic licence symbol is one year from the expiry of the existing IKS or BAG certificate and its replacement by a new Swissmedic authorization. The change-over to the Swissmedic authorization symbol may be made earlier but in this case Swissmedic must be informed that this aspect of the packaging has been modified.