Germany – Pharmaceutical products – Abschluss nicht exkl. Arzneimittel-Rabattvereinb. nach § 130a Abs. 8 SGB V im Wege eines Open-House-Modells zum Wirkstoff Certolizumab pegol (ATC-Code nach WHO: L04AB05)

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 Certolizumab pegol (ATC code according to WHO: L04AB05). 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 they meet and accept the participation requirements. This means that individual contract negotiations will not be conducted and there will be no (delivery) exclusivity. 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 prescription 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 TED (DTVP). To do this, an application for access to the project room is initially required. After the applicant has been released by the contracting authority, the participation documents can 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 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 "Explanation of Contract Terms" stored in the project room. Communication, including the transmission of the participation documents, takes place electronically via the DTVP portal; details can be found in the aforementioned documents. Any contradictory information in the contract notice is due to technical reasons and is not binding. Participation applications can be submitted for the first time by 6 October 2026. All further submission deadlines can be found in the attachment "Submission Deadlines" stored in the project room. If the deadline falls on a Saturday, Sunday or public holiday, the following working day shall apply. In the event of late receipt, the submitted applications will be considered for the next submission deadline. The discount agreement will end, regardless of the date of the contract, by 31 October 2027 at the latest. 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 end 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.