Execution - Golimumabum, solution for injection - NFZ Drug Program

3.3. Contracting Authority's requirements regarding the subject of the order: 1) the offered medicinal product must have approvals, certificates and be registered in accordance with the provisions of law requiring approvals, certificates and registration, 2) the offered medicinal product must be placed on the market in accordance with the requirements of the Act of April 12, 2024, Pharmaceutical Law, consolidated text (Journal of Laws of 2024, item 686), 3) the offered medicinal product must comply with the standards or technical specifications applicable to this product; 3.4. The Contracting Authority allows the possibility of using equivalent products, i.e. with chemical, physical and quality parameters not worse than those specified in the SWZ – exclusively in relation to products whose origin has been specified by the Contracting Authority by indicating trademarks, patents or origin. The Contracting Authority allows the possibility of offering equivalent products specified in the SWZ, i.e. pharmaceutically and therapeutically equivalent and reimbursed by the National Health Fund. Pharmaceutical equivalence defines the situation where compared drugs contain the same amount of active substance in the same dosage form, corresponding to the same comparable standards and intended for administration by the same route; pharmaceutical equivalence does not guarantee therapeutic equivalence, as differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability, and consequently in the effect of the pharmaceutical substance. Therapeutic equivalence - two substances are therapeutically equivalent if they are pharmaceutically equivalent and if, after their administration in the same dose, their effects in terms of both efficacy and safety are as could be expected based on appropriate studies. The Contracting Authority's requirements regarding the subject of the order have been specified in Annex No. 2b to the SWZ. If the Contractor applying for the order offers, by indicating in the price form, a subject of the order equivalent to that specified in the SWZ, they are obliged - in order to confirm that the offered supplies meet the Contracting Authority's requirements specified in the SWZ - to describe each of the equivalent solutions in the price form (Trade name, international name, number of units in the package of the offered product). The Contracting Authority agrees to a change in the dosage form of oral preparations, i.e. pricing: -instead of tablets – coated tablets, ampoules – vials; -instead of coated tablets – tablets, capsules or dragees -instead of capsules – coated tablets, tablets, or dragees Instead of tablets, coated tablets, or slow-release capsules – tablets, coated tablets, or capsules, and modified-release and vice versa. An equivalent solution means a solution that allows achieving the effect intended by the Contracting Authority and specified in the SWZ using other solutions. The Contractor offering solutions equivalent to those described by the Contracting Authority is obliged to define and describe the equivalent solutions, filling in the price form accordingly, the template of which is an annex to the SWZ. 3.5. The Contracting Authority requires the execution of the subject of the order on the terms specified in the agreement. The draft provisions of the public procurement agreement, which will be introduced into the agreement, constitute annexes to the SWZ. INFORMATION ON INTENDED ORDERS REFERRED TO IN ART. 214(1)(7) AND (8), IF THE CONTRACTING AUTHORITY INTENDS TO AWARD SUCH ORDERS The Contracting Authority does not intend to award orders referred to in art. 214(1)(7) of the Pzp Act. The Contracting Authority does not intend to award orders referred to in art. 214(1)(8) of the Pzp Act. DESCRIPTION OF THE CRITERIA THE CONTRACTING AUTHORITY WILL USE TO SELECT THE OFFER, INCLUDING THE WEIGHTS OF THESE CRITERIA AND THE METHOD OF EVALUATING OFFERS 13.1. The evaluation of offers will be carried out based on the criteria specified in the SWZ and their weights. Offers will be evaluated on a point basis. During the evaluation of offers...