Package insert for medicinal products used by professionals

According to Chapter 2.5.3.1 of the WL Guidance document Formal requirements, no patient information is required for certain types of human medicinal products in dispensing categories A and B which in accordance with Art. 14 Para. 2 TPO (Therapeutic Products Ordinance - In German only) are used exclusively by physicians or dentists (e.g. injectables, infusions). Theoretically, however, it is possible to provide patient information in this case. The patient information can then be used as a package insert (in 3 languages) instead of the Information for healthcare Professionals. Otherwise, the Information for healthcare Professionals is used as a package leaflet in accordance with the information in the Guidance document Packaging for human medicinal products, i.e. in two languages.