Conclusion of a non-exclusive discount agreement pursuant to Section 130a (8) of the German Social Code (SGB) on medicinal products containing the active substance risperidone in the formulation of dry matter containing solvent or powder and solvent for solution for injection (ATC code: N05AX08) within the period from 1.7.2021 to 30.6.2023 with any time Possibility of concluding a contract during the term (“open-house model”).

The contractual partners can be viewed at: https://www.aok-gesundheitpartner.de/nds/arzneimittel/rabatt/index_03504.html?bl=nds

With regard to the active substance risperidone in the formulation of dry matter containing solvent or powder and solvent for solution for injection (ATC code: N05AX08), AOK — The Lower-Saxony Health Fund for the period up to the entry into force of exclusive contracts following a formal procurement procedure under the Regulations of Part 4 of the GWB shall apply rebate agreements to all interested pharmaceutical companies, without a selection decision. The contracts are concluded within the framework of an “open-house model” and act as a bridge between the beginning of the generic competition (patent procedure) and the award of exclusive contracts. The contracts offered are not exclusive; contracts with all market participants (pharmaceutical companies) are requested by AOK Niedersachsen. Uniform conditions apply to all participants in the open-house model. The content of the contract, conditions and access procedures are uniform — individual negotiations are generally not conducted. The contract terms are a maximum of twenty-four months, the earliest contract commencement is 1.7.2021. All contracts shall expire no later than 30 June 2023, irrespective of the date of the respective contract. An entry or conclusion of a contract may take place on the first of each month within the twenty-four month period. There is a right of termination for 6 weeks at the end of each month. The AOK — Gesundheitskasse für Niedersachsen reserves the right to replace the non-exclusive open-house discount agreements with exclusive discount agreements during the contract period. With the entry into force of exclusive discount agreements that have been tendered, the open house contracts will be terminated in accordance with the contractual arrangements, i.e. the open-house contracts will end automatically. According to the experience of the AOK Niedersachsen, exclusive discount contracts usually enter into force 6 to 8 months after the publication of the relevant notice of invitation to tender in the Supplement to the Official Journal of the European Union. The future contracting parties in the open-house model are requested to inform themselves regularly in the Supplement to the Official Journal of the European Union regarding these tender notices.

Interested pharmaceutical companies can request the contractual documents and the contractual terms and conditions at the contact address given under I.1).

Contracts for risperidone in the above dosage form (ATC code: N05AX08) will be concluded for the first time with effect from 1.7.2021. Interested parties wishing to become a contracting party on this date must submit the contract documents to be submitted to the address specified in the contract documents by 27 May 2021. It depends on the access at the AOK Lower Saxony. Subsequent contracts can be concluded on the first of each month during the maximum period of twenty-four months. Organisationally, an advance of as a rule 35 calendar days on the part of the AOK is necessary to ensure the necessary work, e.g. the contract notification to Lauer Taxe®. The exact dates of receipt will be announced together with the contract documents. This publication does not constitute the award of a public contract within the meaning of Directive (2014/24/EU) or public procurement law. In order to ensure the widest possible level of transparency for the contracts envisaged, publication is made in the Supplement to the Official Journal of the European Union. In the absence of a corresponding publication form, the contract notice shall be used. The resulting conceptual requirements, such as the “open procedure” method designation, are solely due to the use of this notice form and the publication platform. This does not imperate any other importance, in particular submission to public procurement regulations.