Contributed By Walder Wyss Ltd
Only a small number of sample packages may be distributed per medicine, per year and per healthcare professional. They may be distributed only on the initiative of the healthcare professional and upon their written request. Sample packages must be clearly and permanently marked as a “free sample.” They must contain the necessary information and texts on the container and packaging material as well as an approved package leaflet. In the case of medicines that may be marketed without a package leaflet, the sample package must contain the required information on the container and the packaging material. The sample package must be accompanied by the drug information last approved by Swissmedic or contain a reference to its publication in the list in accordance with Article 67 para. 3 or Article 95b HMG. Sample packages must always correspond to the smallest approved package size and may not be sold. The supply of sample packages containing psychotropic substances or narcotics is subject to the provisions of the Narcotics Control Ordinance. The marketing authorisation holder must ensure that records are kept of the distribution of sample packages (Article 10 AWV).
According to Swissmedic, the following quantities qualify as “small quantity”: A maximum of five packages per healthcare professional, per year and per medicine in the first two years after market introduction and a maximum of two packages per healthcare professional, per year and per medicine from the third year on.