Hungary – Medical equipments, pharmaceuticals and personal care products – Általános és sürgősségi Egészségügyi fogyóanyagok

The MH EK intends to procure general and emergency medical supplies through a framework agreement, based on the provisions of Section 105. (1) a) of the Public Procurement Act, with one tenderer. The total value of the framework agreement is 865 604 065 HUF net, based on Section 105. (1) a) of the Public Procurement Act. The procurer is not obliged to implement the procurement. Performance: through multiple calls, multiple deliveries, with the possibility of issuing partial invoices. The allocation of the framework amount: 1. 6 487 815 HUF 2. 29 492 000 HUF 3. 5 834 094 HUF 4. 2 682 060 HUF 5. 51 732 000 HUF 6. 26 844 800 HUF 7. 810 060 HUF 8. 17 873 130 HUF 9. 614 693 706 HUF 10. 18 358 650 HUF 11. 5 470 200 HUF 12. 3 849 600 HUF 13. 5 371 200 HUF 14. 7 649 100 HUF 15. 17 595 900 HUF 16. 39 980 400 HUF 17. 8 400 000 HUF 18. 2 479 350 HUF. Requirements for the offered product are detailed in the procurement documents. Further Procurement Document: KKD, Technical Description. The tenderer (AT) may only offer product(s) that meet the following: - legally marketable in the member states of the European Union; - new (factory new, not used, not a demo unit); - manufactured according to the essential requirements of EU harmonised standards (or equivalent solutions in case of deviation) and directives. The tender must include: Professional tender: (1) Within the framework of the tender, the tenderer must attach a product information sheet, supervised by the manufacturer or distributor (in copy), for the offered product. The product information sheet supervised by the manufacturer or distributor must contain at least the product name, the manufacturer's name, the country of origin of the product, as well as its technical parameters, characteristics and all data and information from which it can be established that the product meets the technical requirements prescribed in the procurement documents. If the product information sheet is not in Hungarian, the non-Hungarian language document and its Hungarian translation must be attached. By product information sheet supervised by the manufacturer or distributor, we mean a document issued by the direct manufacturer of the product, or its representative authorised for distribution, or in the case of a non-EU manufacturer, a representative authorised for distribution in the EU (EC REP) summarising the functional and technical parameters of the product. AK does not require certification by the manufacturer or distributor, i.e. any product description/prospectus originating from the manufacturer or distributor is sufficient. (2) AT's declaration (CONFORMITY DECLARATION) that the tendered product meets the technical requirements and expectations set out for the product to be procured. The declaration must be made in the commercial table, based on the technical description table, with knowledge of the technical requirements set for the product to be procured: in text, with data, or with a yes/no declaration. Commercial tender: (3) Commercial table (to support the offered price), to be completed according to the specified template. [KKD.7.3.] It must contain the name of the offered product, its item number, manufacturer, country of origin, net and gross unit price, total price, VAT rate, and packaging unit. The name of the offered product, its item number, manufacturer, and the net unit price per unit are considered basic data by AK. The omission of attaching the professional tender to the tender submitted before the deadline renders the tender INVALID. This does not apply if the values determined as basic data in the professional tender can be clearly and unambiguously established in the other parts of the tender. (see KKD 7.3.2.). (X) AT must record in the tender that the product it offers is suitable for medical devices. If the offered product is classified as a medical device, the winning tenderer's contractual obligation is to prove that the offered product meets the requirements of a medical device according to Section 9 (2) of Government Decree 16/2012. (II.16.). (X) AK states in the invitation to tender IV.1.8. that the procedure is subject to the GPA. Accordingly, Section 2. (5) of the Public Procurement Act is applicable. According to Section 2. (5) of the Public Procurement Act, economic operators established in the EU and goods originating in the Community must be given national treatment in the public procurement procedure. For economic operators established outside the EU and for goods not originating in the Community, national treatment must be given in the public procurement procedure in accordance with the obligations of the Member State and the EU in the field of public procurement. In accordance with Section 74. (2) of the Public Procurement Act, the procurer may exclude from the procedure the tenderer for whom national treatment is not required [Section 2. (5)]. AK does not exclude the tenderer (AT) if the manufacturer of the offered product is an economic operator established in the European Union and the European Economic Area, and the offered product, regardless of its country of origin, complies with the EU directives. AT, in relation to whom, taking into account the country of origin of the offered product, 8. "manufacturer": the natural or legal person who manufactures a product, or has a product designed or manufactured, and markets the product under its own name or trademark; 9. "importer": a natural or legal person established in the Union who places a product originating in a third country on the Union market; 10. "distributor": a natural or legal person in the supply chain, other than the manufacturer or importer, who markets a product.