Germany – Pharmaceutical products – Abschluss nicht exkl. Arzneimittel-Rabattvereinb. nach § 130a Abs. 8 SGB V im Wege eines Open-House-Modells zum Wirkstoff Nilotinib (ATC-Code nach WHO: L01EA03)

The subject of this publication is the conclusion of non-exclusive discount agreements pursuant to Section 130a (8) SGB V for medicines with the active substance Nilotinib (ATC Code according to WHO: L01EA03 - excluding Nilotinib dispersed in apple sauce, unless the pharmaceutical company holds patent protection for this). The contract is 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 they meet and accept the participation requirements. As a result, individual contract negotiations are not conducted and (supply) exclusivity is not given. It is pointed out that the procurement quantity is unknown, as this depends on the demand and the development of the number of insured persons, the prescribing behaviour of doctors and the dispensing and stocking behaviour of public pharmacies. Minimum procurement quantities are therefore not guaranteed. Interested pharmaceutical companies can download the participation documents from the project room of the German TED e-Submission Portal (DTVP). An application for access to the project room is required. After the applicant has been released by the contracting authority, the participation documents can be accessed. Absolute confidentiality must be maintained regarding the contents of the participation documents - in particular regarding the contents of the discount 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 authority. If participation is waived, all documents must be destroyed immediately in accordance with data protection regulations. The documents to be submitted are specified in the documents "Cover Letter" and "Explanations of the Contract Terms" stored in the project room. Communication, including the transmission of the participation documents, is carried out electronically via the DTVP e-Submission Portal; details can be found in the aforementioned documents. Any contrary information in the contract notice is due to technical reasons and does not constitute a binding commitment. Applications for participation can be submitted for the first time by 7 July 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, the next working day shall take its place. In the event of late receipt, the submitted applications for participation will be considered for the next submission deadline. The discount agreement ends, regardless of the date of the contract conclusion, at the latest on 31 July 2027. 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 end in accordance with the contractual provisions. According to the contracting authority's experience, exclusive discount agreements generally 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.