The subject of the order is the delivery of recombinant human insulin-like growth factor - 1 (meccasermine) for administration in generally available syringes of low capacity and high accuracy:

- 144,800 mg vial/ampoule of < 50 mg.

AND.

Order description:

1. The drug offered is registered and reimbursed for the treatment of recombinant IGF-1 patients with low age following severe primary IGF-1 deficiency.

2.The offered preparation must meet the conditions of use in the above indication in patients covered by the following new drug programme of the National Health Fund for which the purchase in question is made, i.e.: “Treatment of low-growth children with severe primary deficiency of insulin-like factor 1” recombinant, human insulin-like growth factor- 1.

The preparation contained in vials or ampoules may be in the form of a powder for dissolution, as well as in the form of an already dissolved preparation for direct use. This preparation must be administered in common syringes of small capacity and with sufficiently high accuracy to determine the dosage of the drug.

The Contracting Authority reserves the opportunity to reduce the purchase of the growth factor, but not more than 20% of the subject of the contract, in the event of exceeding the amount allocated for the execution of the contract or in case of objective and legitimate needs arise, in particular the change in demand among patients.

A detailed description of the item of the order is contained in the SWZ and the Designed Contract Terms.

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 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 of a medicinal product issued by the Council of the European Union or the European Commission.

2. In accordance with Article 107 (1) of the Pzp Act, the Contractor is obliged to submit the abovementioned evidence measures in question together with the offer and should exercise every diligence to ensure that these documents are complete and contain all the necessary information enabling the Contracting Authority to them verification for 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 transmit to the Contracting Authority, together with the documents referred to in point 1, an additional document declaring the submission of an application in due time for renewal of the marketing authorisation of the medicinal product or in a timely manner when 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. According to Article 107 (2) of the Law Pzp. The Contracting Authority provides for the possibility of supplementing the above-mentioned evidence measures within the time limit set by the Contracting Authority.

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