Poland - Hand and body fluids

Description

Requirements of the Contracting Authority concerning the subject matter of the contract: 1. the offered medicinal product, medical device must have approvals, certificates and be registered in accordance with legal regulations requiring approvals, certificates and registration,2. the offered medical device must be marketed and used in accordance with the requirements of the Act of 20 May 2010 on Medical Devices (Journal of Laws of 2019, The offered medicinal product must be marketed in accordance with the requirements of the Act on Pharmaceutical Law of 6 September 2001, uniform text (Journal of Laws of 2018, item 1996),4. If the offered medical device does not require notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the Contractor shall be obliged to perform, at its own expense and on its own account, all activities necessary to fulfil all legal requirements related to the product's marketing and use in the Republic of Poland. The Contractor is obliged to perform such activities within the time limits specified in the applicable regulations and to provide the Contracting Authority with appropriate documents confirming the performance of such activities within such time limits.3.4 The Contracting Authority shall allow the use of equivalent products, i.e. products with chemical, physical and quality parameters not inferior to those specified in the ToR - only in relation to products whose origin has been specified by the Contracting Authority as the indication of trademarks, patents or origin. Pharmaceutical equivalence defines a situation where the medicines compared contain the same quantity of a medicinal product in the same form of medicine, meeting the same comparable standards and intended for the same route of administration; pharmaceutical equivalence does not condition therapeutic equivalence, since differences in complementary substances and manufacturing process may give rise to differences in dissolution and bioavailability, and consequently in the effect of the pharmaceutical product. Therapeutic equivalence - two measures are therapeutically equivalent if they are pharmaceutically equivalent and if, after their administration in the same dose, their effects both in terms of effectiveness and safety are as one could expect from appropriate studies.If the Economic Operator applying for the award of the contract offers, by indicating in the Price Form, the subject of the contract equivalent to that specified in the ToR, the Economic Operator is obliged - in order to confirm that the offered deliveries meet the requirements of the Contracting Authority specified in the ToR - to describe each of the equivalent solutions in the price form (Trade name, international name, number of pieces in the packaging of the offered product).A full description in the LIST OF THE CRITERIES TO WHICH THE CONTRACTOR WILL BE DIRECTED BY THE SELECTED OFFER, AND WITHIN THE VALUE OF THIS CRITERIES AND THE PERSON OF THE EVALUATION OF THE OFFER13.1.Tenders will be scored separately with respect to each Task. During the evaluation of tenders, the following criteria will be scored according to the following rules: CRITERION PRICE Weight: 60% TIME LIMITS FOR THE PARTICIPATION OF THE ORDERS Weight: 40% Weight: 40%.

Opportunity closing date

26 August 2019

Value of contract

to be confirmed