Hepatitis A vaccine (inactivated) for use in children, to secure reserve status. Part: 1

I. DEFINITION OF THE SUBJECT OF THE ORDER: 1. Hepatitis A vaccine (inactivated) for use in children, to secure reserve status. Part 1: in the amount of 2,000 doses. 2. When selecting the most advantageous offer, the contracting authority reserves the right to reduce the purchase of medicinal products, but by no more than 20% of the total subject of the order (in each of the above-mentioned parts) in the event of: exceeding the amount allocated for the execution of the order or the emergence of objective and justified needs, in particular changes in demand among patients. 3. The order must be executed in accordance with the requirements specified in the SWZ and PPU. II. EVIDENTIAL MEANS: 2.1. Pursuant to Art. 105 and Art. 106 of the Pzp Act, in order to confirm the compliance of the offered supplies with the requirements, characteristics or criteria specified in the description of the subject of the order or the criteria for evaluating offers or requirements related to the execution of the order, the Contracting Authority requests the Contractors to submit the following documents: A valid, current marketing authorization for the 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, current marketing authorization for the medicinal product issued by the Council of the European Union or the European Commission, 2.2. Pursuant to Art. 107 sec. 1 of the Pzp Act, the Contractor is obliged to submit the aforementioned evidential means together with the offer and should exercise all due diligence to ensure that these documents are complete and contain all necessary information enabling the Contracting Authority to verify their correctness. 2.3. The marketing authorization for the medicinal product must be valid on the day of submitting the offers. 2.4. The composition of the preparation and packaging must be consistent with the content of the documents referred to in point 2.1. 2.5. In the event that the validity of the document expires, the Contractor is obliged to provide the Contracting Authority with an additional document, along with the documents referred to in point 2.1, declaring the timely submission of an application for extension of the marketing authorization for the medicinal product or, if obtained, a valid marketing authorization for the medicinal product. 2.6. The Contractor is obliged to inform the Contracting Authority about the transfer of rights and obligations of the marketing authorization holder to another entity. 2.7. The aforementioned documents must have an expiry date covering the entire period of order execution. 2.8. The documents referred to above are submitted in the manner provided for in the regulations issued on the basis of Art. 70 of the Pzp Act, i.e. in the Regulation of the President of the Council of Ministers of December 30, 2020, on the method of preparing and submitting information and technical requirements for electronic documents and electronic communication methods in public procurement proceedings or competitions. 2.9. Pursuant to Art. 107 sec. 2 of the Pzp Act, the Contracting Authority provides for the possibility of supplementing the aforementioned evidential means once within the deadline set by the Contracting Authority. 2.10. Documents drawn up in a foreign language must be submitted together with a Polish translation.