The subject of the order is the delivery of recombinant human growth hormone for administration in automatic pens (penach):

Part 1: For patients treated under drug programs entitled: "Treatment of short-statured children with somatotropin hypopituitarism (SNP)", "Treatment of short-statured children with Turner Syndrome (TS)", "Treatment of short-statured children with chronic renal failure (CKD)", "Treatment of Prader-Willi syndrome (PWS)", Treatment of severe growth hormone deficiency in adult and adolescent patients after completion of growth promoting therapy in the amount of 973,000 mg.

Part 2: For patients treated under the drug program "Growth hormone therapy of small children born too small for the duration of pregnancy (SGA or IUGR)" in the amount of 198,675 mg.

AND.

Part 1 : For patients treated under drug programs entitled: "Treatment of small children with somatotropin hypopituitarism (SNP)", "Treatment of short-growth children with Turner syndrome (VT)", "Treatment of short-growing children with chronic renal failure (CKD)", "Treatment of Prader-Willi syndrome (PWS)"Treatment of severe growth hormone deficiency in adult patients and adolescents after completion of growth-promoting therapy"

As part of the order, the Ordering Party requires the offer of vial/ampoule cartridges below (<7 mg), and vial / ampoule cartridges above (> 7 mg). Failure to meet the above condition will result in rejection of the offer.

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:

Pursuant to Article 105 and Article 106 of the PPL Act, in order to confirm the compliance of the offered deliveries with the requirements, features or criteria specified in the description of the subject of the contract or the criteria for the evaluation of tenders or requirements related to the performance of the contract, the Contracting Authority shall require the Contractors to provide 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.

AND.

Part 2: For patients treated under the drug program entitled: "Growth hormone treatment of short children born too small compared to the duration of pregnancy (SGA or IUGR)"

As part of the order, the Ordering Party requires the offer of vial/ampoule cartridges below (<7 mg), and vial / ampoule cartridges above (> 7 mg). Failure to meet the above condition will result in rejection of the offer.

Detailed description of the item of the order is included in the SWZ and the Designed Contract Terms

II.

Measures of evidence in question:

Pursuant to Article 105 and Article 106 of the PPL Act, in order to confirm the compliance of the offered deliveries with the requirements, features or criteria specified in the description of the subject of the contract or the criteria for the evaluation of tenders or requirements related to the performance of the contract, the Contracting Authority shall require the Contractors to provide 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.