Flyer Substitution Exclusion List

6 The application to the SEL An application for inclusion on the substitution exclusion list can be submitted by a phar- maceutical entrepreneur at any time, as there is as yet no official and structured application procedure or corresponding forms or rules of procedure. Nevertheless, certain formal requirements and also certain standards have proven themsel- ves in the application to the G - BA. Due to the fact that this is not an official and structured application procedure, times and deadlines are not specified, but cannot be influenced by the applicant. By submitting an official SEL application to the G - BA, the applicant is also entitled to partici- pate in the G - BA hearings on SEL and to argue in favor of his application. Experience shows that an SEL application takes about 1 year until a decision is made by the G - BA. Formal requirement The core of the procedure is the legally prescribed inclusion of the thematically (possibly) affected stakeholder groups in the decision - making process. These include, first and fore- most, experts from medical and pharmaceutical science and practice, relevant umbrella or- ganizations of pharmaceutical entrepreneurs formed to represent economic interests, affec- ted pharmaceutical entrepreneurs, professional representatives of pharmacists, and rele- vant umbrella organizations of medical associations of special therapeutic directions. They are addressed by the G - BA, but can also submit an application for the inclusion of a drug in the substitution exclusion list themselves (which, however, does not have to be dealt with by the G - BA). Process flow Entitled to request ( no formal determination of the application) Manufacturer Patient Associations Professional societies Subcommittee Drugs Draft resolution Resolution of the G - BA