1. Within the framework of the contract, two tasks were identified:

Task: 1 Concentrate of recombinant coagulation factor VIII minimum of the second generation together with successive deliveries to Haemophilia Treatment Centres – as part of the National Health Fund programme entitled "Prevention of bleeding in children with haemophilia A and B".

Task: 2 Concentrate of recombinant coagulation factor VIII minimum of the second generation together with successive deliveries to Regional Blood Donation and Haemotherapy Centres – as part of the Ministry of Health programme entitled "National Programme for the Treatment of Patients with Haemophilia and Related Hemorrhagic Disorders for 2024-2028".

2. The Contracting Authority requires the Contractor to submit one bid for both tasks constituting the subject of the contract.

3. The joint purchase is aimed at ensuring the compatibility of the drugs used in both of the above-mentioned programs - the Contracting Authority requires the Contractor to offer the same type of recombinant coagulation factor concentrate VIII or minimum of the second generation as part of both tasks.

I. Determination of the object of the order:

Task 1: The subject of the contract includes the supply of recombinant coagulation factor concentrate VIII minimum of the second generation as part of the implementation of the drug program of the National Health Fund, as well as the supply of infusion kits to vascular ports for a specified number of patients, the organization of home deliveries for the indicated number of patients, the disposal of single-use equipment and the control of drug consumption. The offered subject of the order must have a valid decision, i.e. be covered by a refund as of January 1, 2024.

Task 2: The subject of the contract includes the supply of a concentrate of recombinant coagulation factor VIII minimum of the second generation as part of the implementation of the health policy program of the Ministry of Health, as well as the supply of infusion sets to vascular ports for a specified number of patients.

II. Measures of evidence in question:

1. Pursuant to Article 105 and Article 106 of the Pzp. Act, in order to confirm the conformity of the supply offered with the requirements, characteristics or criteria specified in the description of the subject of the contract or the criteria for the evaluation of tenders or the requirements related to the execution of the contract, the Contracting Authority shall request from the Contractors submission of the following documents:

- A valid marketing authorization for a medicinal product in the Territory of the Republic of Poland issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,

or

- A valid marketing authorisation for a medicinal product issued by the Council of the European Union or the European Commission.

and

- Summary of Product Characteristics (SmPC),

and/or

- Copies of scientific publications/clinical evidence (in case the SmPC does not confirm the dosage/declared dose),

2. Pursuant to Article 107(1) of the Public Procurement Law, the Contractor is obliged to submit the above-mentioned means of evidence together with the tender and shall exercise due diligence to ensure that these documents are complete and contain all the necessary information enabling the Contracting Authority to verify their correctness.

3. The marketing authorisation of the medicinal product must be valid and up-to-date at the date of submission of tenders.

4. The composition of the preparation and packaging must be in accordance with the contents of the documents referred to in point 1.

5. Where the validity of the document expires, the Contractor shall be obliged to forward to the Contracting Authority, together with the documents referred to in point 1, an additional document declaring the submission in due course of an application for the renewal of the marketing authorisation of the medicinal product or in if it is obtained a valid marketing authorisation of the medicinal product.

6. The Contractor shall be obliged to inform the Contracting Authority of the transfer to another entity of the rights and obligations of the responsible entity arising from the marketing authorisation of the medicinal product.

7. The documents must have an expiry date covering the entire period of execution of the contract.

8. The documents referred to above are submitted as provided for in the provisions issued pursuant to Article 70 of the Law Pzp., i.e. in the Regulation of the President of the Council of Ministers of 30 December 2020 on the method of preparation and transmission of information and technical requirements for documents electronic communications and means of electronic communication in the procedure for the award of a public contract or competition.

9. Pursuant to Article 107(2) of the Public Procurement Law, the Contracting Authority provides for the possibility of supplementing the above-mentioned means of evidence once within the time limit set by the Contracting Authority – applies to permits.

10. Pursuant to Article 107(3) of the PPL, the Contracting Authority does not provide for the possibility of supplementing the above-mentioned means of evidence concerning the SmPC and copies of scientific publications/clinical evidence, because the evidence in question is used to confirm compliance with the characteristics or criteria specified in Chapter IX of the Terms of Reference in the description of the tender evaluation criteria.

11. Documents drawn up in a foreign language are submitted together with translation into Polish.