Germany – Pharmaceutical products – Abschluss nicht-exklusiver Vereinbarungen über Arzneimittel mit dem Wirkstoff Roxadustat (ATC-Code: B03XA05) im Wege eines Open-House-Modells

The subject of this publication is the conclusion of non-exclusive agreements for medicinal products containing the active substance Roxadustat (ATC Code: B03XA05). The contract award will take place within the framework of an 'Open-House' model, i.e. a contract award is open to all interested pharmaceutical companies within the participation period, provided they meet and accept the participation requirements. This means that individual contract negotiations will not be conducted and (supply) exclusivity will not be given. It is noted that the order quantity is unknown, as it depends on demand and the development of the number of insured persons, on the prescription behaviour of doctors, and on the dispensing and stocking behaviour of public pharmacies. Minimum order quantities will therefore not be guaranteed. Interested pharmaceutical entrepreneurs can download the participation documents via the project room of the German TED e-Submission Portal (DTVP). To do this, an application for access to the project room is first required. After the applicant has been enabled by the contracting entity, the participation documents can then be accessed. Absolute confidentiality must be maintained regarding the content of the participation documents - in particular regarding the content of the agreement and the discounts mentioned therein. Full or partial disclosure or making available of contents of the participation documents to or for third parties requires the prior written consent of the contracting entity. If participation is waived, all documents must be destroyed immediately in accordance with data protection regulations. The documents to be submitted are set out in the documents "Cover Letter" and "Explanations of the Contract Terms" stored in the project room. Communication, including the transmission of the participation documents, takes place electronically via the DTVP e-Submission Portal; details can be found in the aforementioned documents. Any contrary indications in the contract notice are due to technical reasons and do not constitute a binding commitment. Participation applications can be submitted for the first time by 30 April 2026. All further submission deadlines can be found in the attachment "Submission Deadlines" stored in the project room. If the deadline for submission falls on a Saturday, Sunday or a public holiday throughout Germany, the next working day shall take the place of such a day. In the event of late receipt, the submitted participation applications will be considered for the next submission deadline. The agreement ends, irrespective of the date of the contract conclusion, at the latest on 31 May 2028. The contracting entity reserves the right to terminate the open-house procedure prematurely, in particular in the event of the conclusion of exclusive agreements; in this case, the agreements already concluded end in accordance with the contractual provisions. According to the experience of the contracting entity, exclusive agreements usually come into force 8 to 12 months after the publication of the corresponding contract notice in the Supplement to the Official Journal of the European Union.