Germany – Pharmaceutical products – Abschluss nicht exkl. Arzneimittel-Rabattvereinb. nach § 130a Abs. 8 SGB V im Wege eines Open-House-Modells zum Wirkstoff Tolvaptan (amtlicher ATC-Code: G04BX21)

The subject of this publication is the conclusion of non-exclusive discount agreements pursuant to § 130a para. 8 SGB V for medicinal products with the active substance Tolvaptan (official ATC code: G04BX21). The contract will be concluded within the framework of a so-called Open-House model, i.e. a contract conclusion is open to all interested pharmaceutical companies within the participation period, provided that they meet and accept the participation requirements. This means that individual contract negotiations are not conducted and (supply) exclusivity is not given. It is pointed out that the quantity to be procured is unknown, as it depends on demand and the development of the number of insured persons, the prescribing behaviour of doctors, and the dispensing and stocking behaviour of public pharmacies. Accordingly, minimum procurement quantities are not guaranteed. Interested pharmaceutical companies can download the participation documents from the project room of the German Tendering 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 authority, 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 discount agreement and the discounts mentioned therein. Any complete or partial disclosure or provision of content of the participation documents to or for third parties requires the prior written consent of the contracting authority. 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 tendering portal DTVP; details can be found in the aforementioned documents. Any contradictory information in the contract notice is due to technical reasons and does not constitute a binding commitment. Participation applications can be submitted for the first time by 05.08.2026. 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 apply in place of such a day. If the submission is received late, the submitted participation applications will be considered for the next submission deadline. The discount agreement expires, regardless of the date of the contract conclusion, at the latest by 31.08.2028. The contracting authority reserves the right to terminate the Open-House procedure prematurely, in particular in the event of the conclusion of exclusive discount agreements; in this case, the discount agreements already concluded will expire in accordance with the contractual provisions. According to the contracting authority's experience, exclusive discount 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.