Poland – Pharmaceutical products – Zakup i dostawy produktów leczniczych krwiopochodnych, siarczanu protaminy, leków hemostatycznych stosowanych w trakcie zabiegów operacyjnych. .

The subject of the procurement is the purchase and successive delivery of blood-derived medicinal products, protamine sulphate, and haemostatic drugs used during surgical procedures, in accordance with the requirements specified in: • Annex No. 5 – Price Form / Description of the Subject of the Procurement, • Annex No. 4 – Draft Contract, in which the detailed conditions of supply, quality, deadlines and complaints have been specified. The procurement has been divided into 19 parts (packages), in accordance with Annex No. 5. The contractor may submit an offer for any number of packages, with the reservation of the obligation to offer the entire range within a given package. All offered medicinal products must have: • a current marketing authorisation issued by the URPL, • or marketing authorisation issued by the European Medicines Agency (EMA). The supplied medicinal products, which have the status of a reimbursed drug, must be included in the current list of reimbursed drugs published by the Minister of Health. Non-reimbursed medicinal products, in particular blood-derived products, protamine sulphate, haemostatic drugs used during surgical procedures and products used in drug programs, must be supplied in accordance with the requirements specified in the SWZ, regardless of their reimbursement status. The contractor is obliged to ensure that all supplied products comply with the applicable legal provisions, current Characteristics of Medicinal Products and clinical requirements resulting from their use. The contractor is obliged to provide in the offer: the trade name, manufacturer, EAN code. The purchaser allows a change in quantity from pieces to packages with the appropriate price conversion. The purchaser agrees to a change in the size of the packages, with the reservation of not exceeding double the size of the package for oral forms such as tablets, syrups, etc., unless otherwise agreed for the specified individual position. In the case where a single package containing a different quantity (different weight) than the quantity specified in the SWZ, it should be converted to two decimal places according to arithmetic rounding. The purchaser allows the offer of equivalent products, provided that the contractor proves that the offered product meets all the requirements specified in the SWZ, in particular regarding composition, strength, form, method of administration, purpose, quality parameters, safety, effectiveness and possession of the appropriate marketing authorisation (URPL/EMA) or CE certification in accordance with MDR 2017/745. The contractor is obliged to submit documents confirming equivalence, in particular: ChPL, manufacturer's documents, declaration of equivalence. In any case of using in the description of the subject of the procurement of the norms, technical assessments, technical specifications and technical reference systems referred to in Article 101(1)(2) and (3) of the Pzp Act, the contractor should assume that such a reference is accompanied by the words: "or equivalent".