Germany – Pharmaceutical products – Abschluss nicht-exklusiver Vereinbarungen über Arzneimittel mit dem Wirkstoff Melatonin (ATC-Code: N05CH01) 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 melatonin (ATC code: N05CH01), limited to sustained-release formulations of the strengths 1mg and 5mg. 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 prescribing behaviour of doctors and on the dispensing and stocking behaviour of public pharmacies. Minimum order quantities will therefore not be guaranteed. Interested pharmaceutical companies can download the participation documents from the project room of the German Tender Portal (DTVP). To do this, an application for access to the project room is required first. 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 agreement and the rebates 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 result from 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 tender portal DTVP; 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 5 March 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 will take its place. In the event of late receipt, the submitted participation applications will be considered for the next submission deadline. The agreement ends, regardless of the date of the contract conclusion, at the latest on 31 March 2028. The contracting authority 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 will end in accordance with the contractual provisions. According to the experience of the contracting authority, 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.