Romania – Pharmaceutical products – Framework agreement: Supply of medicines, food supplements and nutritional or phytotherapeutic support products necessary for administering treatments prescribed to beneficiaries of social services within the centers subordinated to DGASPC Neamț, with individual dispensing based on a medical prescription and payment of the personal contribution by the contracting authority

Opportunity description

Several residential and day centers operate within DGASPC Neamț, where approx. 800 beneficiaries with various types of medical conditions are cared for and the administration of treatments prescribed by physicians is ensured. The products covered by this procedure may be supplied by any economic operator which, under the applicable legislation, has the right to market the respective products in Romania. In the case of products included in Lot 1 – Medicines included in the Nomenclature of medicinal products for human use, supply shall be carried out in compliance with the regulations specific to the pharmaceutical field. In the specific context of this procurement, the contracting authority may purchase medicines only from economic operators authorized to market medicines directly to the end user, namely authorized pharmacies, because the institution does not have its own pharmacy. In the case of products included in Lot 2 – Food supplements and nutritional or phytotherapeutic support products that are not included in the Nomenclature of medicinal products for human use, supply shall be carried out in compliance with the legislation applicable to the marketing of these products. Exception: The contracting authority has on record beneficiaries included in national curative health programs carried out in accordance with Government Decision no. 155/2017, namely programs for the treatment of HIV/AIDS infection and chronic viral hepatitis. The medicines related to these programs are provided and financed from the National Single Health Insurance Fund through designated healthcare units and pharmacies, in accordance with the framework contract concluded with the National Health Insurance House. Since these products are not paid for from the contracting authority's budget, they are not included in the estimated value of this award procedure, are not the subject of the framework agreement to be awarded and will not be requested through the subsequent contracts. The contracting authority will evaluate the tenders based on the full price of the medicines offered (retail price). The reimbursement or free-of-charge status of medicines is determined exclusively on the basis of the medical prescription and the rules of the social health insurance system and is not an element in the evaluation of tenders. For medicines dispensed on the basis of reimbursed or free medical prescriptions, the supplier will invoice the contracting authority exclusively for the personal contribution (payment difference) attributable to the beneficiary, substantiated by a centralized schedule of prescriptions. For non-reimbursed medicines, the supplier will invoice their full value. The estimated value of the framework agreement is 4.939.519,74 lei excluding VAT. Description of the lots and the estimated values (in lei, excluding VAT) of the framework agreement and of the largest subsequent contract: Lot 1 - Medicines included in the Nomenclature of medicinal products for human use: Max. FA 4.229.479,39 / min. FA 731319,24 and max. SC 2.483.963,39 / min. SC 373.698,69; Lot 2 - Food supplements and nutritional or phytotherapeutic support products that are not included in the Nomenclature of medicinal products for human use: Max. FA 710.040,35 lei excluding VAT / min. FA 120.364,51 and max. SC 416.386,77 / min. SC 61.701,08. Details regarding the commercial conditions and the technical specifications relating to the requested products, within each individual lot, can be found in the Tender Specifications attached to the procedure. Pursuant to the provisions of Art. 160 para. (2) of Law 98/2016, the following deadlines are established regarding requests for clarification: a) deadline for receipt of requests for clarification: on the 18th day before the deadline for submission of tenders;/ b) deadline by which the contracting authority will respond clearly and concretely to all requests for clarification: on the 11th day before the deadline for submission of tenders. The request for clarification must be submitted in SEAP (https://e-licitatie.ro/pub). The lot includes products that hold a marketing authorization issued in accordance with pharmaceutical legislation and are regulated as medicines. These products are prescribed by a physician and are identified by the international nonproprietary name (INN), being therapeutically standardized. The lot includes 1501 products whose technical specifications and estimated quantities can be found in the annex to the Tender Specifications: Annex 1 - List of products and their maximum estimated quantities provided for the period of the framework agreement (12 months). Additional information regarding the products in this lot can be found in chap. 3.3.1. Products requested in the Tender Specifications Estimated value of the largest subsequent contract anticipated to be awarded during the framework agreement: 2.483.963,39 lei excluding VAT. Subsequent contracts will be concluded at a frequency of one - seven months, depending on the needs of the contracting authority The dates proposed in the estimated schedule represent the intention of the contracting authority, not a firm commitment by the contracting authority/entity regarding the award of subsequent contracts, based on the working assumption that no unforeseeable events/circumstances will arise that could not have been taken into account when the award procedure was initiated, and that the necessary financial resources will also be ensured. The medicinal treatment of beneficiaries is established exclusively by authorized medical personnel, on the basis of consultations and medical documents, and the contracting authority is required to ensure its administration. Thus, the need for medicines is determined by individual medical prescriptions and may vary depending on changes in the beneficiaries' state of health, changes to therapeutic regimens or the emergence of new treatments. For this reason, the quantities provided under the framework agreement are estimates, established on the basis of previous consumption and the forecast needs of the beneficiary centers, without representing a firm purchasing obligation for the contracting authority. The estimated quantities for each center are indicative and are established on the basis of estimated consumption at the centers subordinated to DGASPC Neamț. During the performance of the framework agreement and subsequent contracts, the contracting authority reserves the right to redistribute quantities among centers, depending on the beneficiaries' actual needs, while observing the total quantities estimated at contracting authority level. The products included in Lot 2 are used in the institution's practice as nutritional, phytotherapeutic or adjuvant support products for maintaining the beneficiaries' state of health. The lot includes products that do not have medicinal product status, do not hold a marketing authorization and are marketed on the basis of notification in accordance with the legislation on food supplements. They are not standardized by INN, and their composition and presentation form differ significantly between manufacturers. The lot includes 327 products whose technical specifications and estimated quantities can be found in the annex to the Tender Specifications: Annex 1 - List of products and their maximum estimated quantities provided for the period of the framework agreement (12 months). Additional information regarding the products in this lot can be found in chap. 3.3.1. Products requested in the Tender Specifications Estimated value of the largest subsequent contract anticipated to be awarded during the framework agreement: 416.386,77 lei excluding VAT. Subsequent contracts will be concluded at a frequency of one - seven months, depending on the needs of the contracting authority The dates proposed in the estimated schedule represent the intention of the contracting authority, not a firm commitment by the contracting authority/entity regarding the award of subsequent contracts, based on the working assumption that no unforeseeable events/circumstances will arise that could not have been taken into account when the award procedure was initiated, and that the necessary financial resources will also be ensured. The treatment of beneficiaries is established by authorized medical personnel, on the basis of consultations and medical documents, and the contracting authority is required to ensure its administration. Thus, the need for food supplements or nutritional or phytotherapeutic support is determined by individual medical prescriptions and may vary depending on changes in the beneficiaries' state of health, changes to therapeutic regimens or the emergence of new treatments. For this reason, the quantities provided under the framework agreement are estimates, established on the basis of previous consumption and the forecast needs of the beneficiary centers, without representing a firm purchasing obligation for the contracting authority. The estimated quantities for each center are indicative and are established on the basis of estimated consumption at the centers subordinated to DGASPC Neamț. During the performance of the framework agreement and subsequent contracts, the contracting authority reserves the right to redistribute quantities among centers, depending on the beneficiaries' actual needs, while observing the total quantities estimated at contracting authority level. Procedure: open. Estimated value: 4,939,519.74 RON. Review the original TED notice for the complete requirement, lots, amendments and attachments.