Flyer application support

4 Applications in the outpatient sector Below the laws, the conditions of the regulatory institutions prevail. The legislator has trans- ferred these tasks to the corresponding institutions on a sovereign basis. Consequently, the outpatient and inpatient sectors each have to deal with specific regulatory requirements and processes if they want to obtain reimbursement for their products. In the outpatient sector, a distinction is made between 3 separate areas: marketing authori- zation, market access, and reimbursement of drugs or medical devices. The following figure shows the relevant application processes for the medical device sector. Specific framework conditions apply to each of the applications shown in the figure. The permission requirement in the outpatient sector is particularly important, as no products or other health care services may be introduced here without permission from the G - BA. A complicated application is also required for inclusion in the official list of therapeutic appli- ances of the GKV (§ 139 SGB V), which passes through the committees with a complex and less transparent procedure. The applications for new, innovative methods according to §§ 137 e and h SGB V are also very time - consuming and complicated. Moreover, these procedures tend to take years rather than a few months, and they involve not inconsiderable effort and expense for the applicant, with a positive outcome by no means certain.