Table 1.

Important terms in the German Medicinal Products Act (Deutsches Arzneimittelgesetz, AMG) www.gesetze-im-internet.de/bundesrecht/amg_1976/gesamt.pdf, as well as particular features of the Austrian and Swiss drug laws

Finished medicinal products

Section 4 Sub-section 1, AMG § 4 (1): „Finished medicinal products are medicinal products which are manufactured beforehand and placed on the market in packaging intended for distribution to the consumer or other medicinal products intended for distribution to the consumer, in the preparation of which any form of industrial process is used or... are produced commercially“.

Marketing authorization

Section 21 Sub-section 1, AMG § 21 (1): „Finished medicinal products which are medicinal products as defined in Section 2 sub-section 1 or sub-section 2 number 1, may only be placed on the market within the purview of the present Act, if they have been authorised by the competent higher federal authority...“

Individual formulations (NPP)

Section 21 Sub-section 2, AMG § 21 (2): “A marketing authorization (Zulassung) shall not be required for medicinal products which ... No. 1g: ... are therapeutic allergens manufactured to order for individual patients...”

Important Terms in the Austrian Drug Law (Österreichisches Arzneimittelgesetz)

AMG § 7a(1): “Medicinal products containing antigens or half-antigens intended for the detection of specific antibodies and protective substances for desensitization or hyposensitization, provided they are not always produced in the same composition and under the same designation in a defined form intended for distribution to the consumer or user, are only permitted to be distributed domestically or held ready for domestic distribution if the Federal Office for Safety in Healthcare has approved by notification the manufacturing process including chemical/pharmaceutical documentation, for this medicinal product.“

Situation in Switzerland

Under the terms of the Swiss Federal Law on Medicinal Products [Heilmittelgesetz, HMG; Art. 9 (1)] dated December 15th 2000, allergen preparations intended for AIT are considered as medicinal products requiring marketing approval (SR812.21, www.admin.ch/opc/de/classified-compilation/20002716/index.html#a9). Allergen preparations used under the terms of the exemption clause [HMG Art. 9 (2)], for example as individual formulations (patient-specific mixture of allergens, NPP), are exempt from marketing authorization.

A new regulation came into force in 2010 to simplify the marketing approval process for allergen preparations (Allergenverordnung, AllergV SR812.216.2, www.admin.ch/opc/de/classified-compilation/20060055/index.html). The simplification of the marketing approval procedure consists of the fact that the market authorization documentation can be based on published literature (from scientifically recognized sources) or on documentation for other allergen preparations (a reference preparation of the same manufacturer). Allergen preparations containing recombinant allergens or genetically modified organisms are excluded from this simplified marketing authorization procedure.

In cases where marketing authorization has already been granted in a country with comparable medicinal drug regulations and a comparable marketing authorization process, it is possible, under the terms of Art. 13 of the Swiss HMG to take these results into consideration with regard to marketing authorization in Switzerland.