Purchase of antiretroviral drugs; Parts 1÷3

… Procurement Act, in order to confirm the conformity of the supplies offered with the requirements, characteristics or criteria set out in the description of the subject-matter of the contract or the tender evaluation criteria or requirements related to the performance of the contract, the contracting authority requires economic operators to provide the following documents: 2.1.1. A valid marketing authorisation valid on the date of submission of tenders in Poland issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or a valid marketing authorisation valid on the date of submission of tenders issued by the Council of the European Union or the European Commission. 2.2. The Ordering Party accepts the possibility of offering the subject of the order in foreign-language packaging. The contractor must provide at least one instruction in Polish attached to the packaging regarding the storage and storage of the subject of the contract and a copy of the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to the exemption in whole or in part from the obligation to prepare packaging marking and package leaflet in Polish or confirmation of the submission of an application for such consent. If consent is obtained, the contractor is obliged to provide a copy to the contracting authority at the latest on the day of signing the contract. 2.3. These documents must have a validity period covering the entire duration of the contract. 2.4. In the event that the validity of the document expires, the Contractor shall provide the Contracting Authority with an additional document, together with the documents referred to in point 2.1.1, declaring the timely submission of an application for renewal of the marketing authorisation for the medicinal product or, if granted, a valid marketing authorisation for the medicinal product. 2.5. In accordance with Article 107(1) CTMR, 1 of the Public Procurement Act, the Contractor is obliged to submit the above-mentioned means of proof together with the tender and should exercise all due diligence to ensure that these documents are complete and contain all the necessary information enabling the Ordering Party to verify them for accuracy. 2.6. In accordance with Article 107(2) of the Public Procurement Act, the contracting authority provides for the possibility of supplementing the above-mentioned evidence once within the time limit set by the contracting authority. 2.7. The means of proof referred to above shall be submitted in the manner provided for in the provisions issued on the basis of Article 70 of the Public Procurement Act. – i.e. the Regulation of the Prime Minister of 30 December 2020 on the method of preparing and transmitting information and technical requirements for electronic documents and means of electronic communication in a public procurement procedure or a competition. 2.8. Documents drawn up in a foreign language are submitted together with a translation into Polish. · 1. International chemical name of the medicinal product: Darunavir/Cobicistat | 800mg/150mg | tablet | 30; Power or volume: 800/150mg; Form of the farm.: tablet; Pack size: 30. Number of packages: 1600 2. MEASURES TO BE PROVIDED FOR: 2.1. Pursuant to Articles 105 and 106 of the Public Procurement Act, for the purpose of