Poland - Medical devices, pharmaceuticals and personal care products

Description

All offered medicinal products must be authorized for marketing in Poland in accordance with the provisions of the Pharmaceutical Law of September 6, 2001. (Journal of Laws of 2021, item 1977, 2120) . -. In the event that the Ordering Party allows offering products that do not meet the above provision, it will specify in Col. 3 of Appendix No. 1 DETAILS:a) In the case of products that are not medicinal products, the regulations authorizing the marketing of these products in Poland shall apply.b) All offered medical devices, must be authorized for marketing in accordance with the Law on Medical Devices of April 7, 2022 (Journal of Laws 2022.974 as amended)c) All offered foodstuffs for special nutritional use must be authorized for in accordance with the Regulation of the Minister of Health of September 16, 2010. (Journal of Laws of 2015, item 1026).d) All offered pharmaceutical raw materials must comply with the provisions of the Pharmaceutical Law.
1.1 THREE-COMMUNICATION BAG, CONTAINING AMino ACIDS, GLUCOSE, FATS (INCLUDING OMEGA 3 ACIDS), ELECTROLITES FOR SUSPENSION BY CENTRAL VITES, WITH A CONTENT OF 4 TO 5 G of Nitrogen IN THE OFFERED COVERAGE of 493 ml to 625 ml; 1 /12601.2. THREE-CELL SACK, CONTAINING AMino ACIDS, Glucose, FATS (INCLUDING OMEGA 3 ACIDS), ELECTROLITES; for parenteral nutrition by the central vein route, with nitrogen content of 8 to 10 G of nitrogen in the OFFERED VOLUME, bag from 986 ml to 1250 ml; 1 /16001.3. THREE-CELL SACK, CONTAINING AMino ACIDS, Glucose, FATS (INCLUDING OMEGA 3 ACIDS), ELECTROLITES; for parenteral nutrition by the central vein route, with nitrogen content of 10 to 12 G of nitrogen in the OFFERED VOLUME, tubing from 1250 ml to 1477 ml; 1 /5401.4. THREE-CELL SACK, CONTAINING AMino ACIDS, GLUCOSE, FATS (INCLUDING OMEGA 3 ACIDS), ELECTROLITES FOR NON-ELECTRIC ROUTINE FOOD, WITH CARBON CONTENT FROM 15 TO 16 G OF NITROGEN IN THE OFFERED VOLUME BAGS from 1875 ml to 1970 ml; 1 /100 TWO-COMMUNITY BAG FOR NON-ELECTRIC, CENTRAL AND ROUTE feeding, CONTAINING AMino ACIDS, GLUCOSE, ELECTROLITES 1000 ml 1 /50 3.1. THREE-CELL SACK, CONTAINING AMino ACIDS, GLUCOSE, FATS (INCLUDING OMEGA 3 ACIDS), ELECTROLITES FOR NON-ELECTRIC ROUTINE AND ROUTINE FOODING, WITH CARBON CONTENT FROM 3 TO 3.5 G OF CARBON IN THE OFFERED VOLUME Bag from 850 ml to 1000 ml; 1 /20003.2.THREE-COMMUNIC BAG, CONTAINING AMino ACIDS, GLUCOSE, FATS (INCLUDING OMEGA 3 ACIDS), ELECTROLITES FOR NON-ELECTRIC ROUTE USE IN CENTRAL AND ROUTE VITES, WITH CARBON CONTENT FROM 5.6 TO 6.2 G OF ATTITUDE IN THE OFFERED VOLUME BAG from 1200 ml to 1250 ml; 1 /12003.3.THREE-CELL SACK, CONTAINING AMino ACIDS, GLUCOSE, FATS (INCLUDING OMEGA 3 ACIDS), ELECTROLITES FOR NON-ELECTRIC ROUTINE AND VEGETARY DIVERSION, WITH CARBON CONTENT FROM 6 TO 7.4 G G OF ATTITUDE IN THE OFFERED VOLUME bag from 1400 ml to 1500 ml; 1 /400 4.1. THREE-CELL SACK, CONTAINING AMino ACIDS, GLUCOSE, FATS, ELECTROLITES FOR NON-ELECTRIC ROUTINE FOOD, WITH CARBON CONTENT FROM 5 TO 7 G OF NITROGEN IN THE OFFERED VOLUME bag from 625 ml to 1030 ml; 1 /5404.2. THREE-COMMUNIC BAG, CONTAINING AMino ACIDS, GLUCOSE, FATS, ELECTROLITES FOR NON-ELECTRIC ROUTINE FOOD, WITH 8 TO 10.5 G OF NITROGEN IN THE OFFERED VOLUME bag from 1250 ml to 1550 ml; 1 /9004.3. THREE-CELL SACK, CONTAINING AMino ACIDS, GLUCOSE, FATS, ELECTROLITES FOR NON-ELECTRIC ROUTINE FOODING, WITH A CONTENT OF 10.5 TO 15 G OF NITROGEN IN THE OFFERED VOLUME bag from 1875 ml to 2060 ml; 1 /50 5.1. HIGH-PROTEIN THREE-CHAMBER BAG DEDICATED TO INTENSIVE CARE UNITS, HIGH-PROTEIN, LOW-GLUCOSE FORMULA WITH OLIVE OIL FAT EMULSION TO COVER DAILY PROTEIN REQUIREMENTS WHILE AVOIDING EXCESSIVE FLUID AND GLUCOSE SUPPLY; LOW NON-POTEIN ENERGY TO NUTRITION RATIO, 93 KCAL/1G NUTRITION; HIGH NUTRITION CONTENT of 9G NUTRITION IN 1000 ML; COVERAGE OF PROTEIN REQUIREMENT IS ABOUT 1.5/KG/DAY pouch of 1000 ml 1 /14005.2. HIGH-PROTEIN THREE-CHAMBER BAG DEDICATED TO INTENSIVE CARE UNITS, HIGH-PROTEIN, LOW-GLUCOSE FORMULA WITH A FAT EMULSION CONTAINING OLIVE OIL TO COVER DAILY PROTEIN REQUIREMENTS WHILE AVOIDING EXCESSIVE FLUID AND GLUCOSE SUPPLY; LOW NON-POTEIN ENERGY TO NUTRITION RATIO, 93 KCAL/1G NUTRITION; HIGH NUTRITION CONTENT of 9G NUTRITION IN 1000 ML; COVERAGE OF PROTEIN REQUIREMENT IS ABOUT 1.5/KG/DAY pouch 1500 ml 1 /400 6.1. A THREE-CHAMBER BAG WITH HIGH PROTEIN CONTENT DEDICATED TO INTENSIVE CARE UNITS, USED DURING CONTINUOUS RENAL REPLACEMENT THERAPY TO COMPENSATE FOR THE LOSS OF AMINO ACIDS ON THE FILTER; NON-POTEIN ENERGY TO NITRIC ENERGY RATIO IS 53 KCAL/G N; COVERAGE OF DAILY PROTEIN REQUIREMENT TO 2G/KG/DOB (12 G N /1000 ML) bag 650 ml 1 4006.2. THREE-CHAMBER BAG WITH HIGH PROTEIN CONTENT DEDICATED TO INTENSIVE CARE UNITS, USED DURING CONTINUOUS RENAL REPLACEMENT THERAPY TO COMPENSATE FOR THE LOSS OF AMINO ACIDS ON THE FILTER; NON-POTEIN ENERGY TO NITRIC ENERGY RATIO IS 53 KCAL/G N; COVERAGE OF DAILY PROTEIN REQUIREMENT TO 2G/KG/DAIL (12 G N /1000 ML) bag 1000 ml 1 15006.3. THREE-CHAMBER BAG WITH HIGH PROTEIN CONTENT DEDICATED TO INTENSIVE CARE UNITS, USED DURING CONTINUOUS RENAL REPLACEMENT THERAPY TO COMPENSATE FOR THE LOSS OF AMINO ACIDS ON THE FILTER; NON-POTEIN ENERGY TO NITRICIDE RATIO IS 53 KCAL/G N; COVERAGE OF DAILY PROTEIN REQUIREMENT TO 2G/KG/DAIL (12 G N /1000 ML) pouch 1500 ml 1 800 NUTRITION PREPARATE CONTAINS ALANYLO-GLUTAMINE DUPEPTIDE bottle. 20 % 100 ml 1 500 HIGH PERCENTAGE FISH OIL EMULSION vial 100 ml 1 10 FAT EMULSION 20 % op. 500 ml 10 5 AMino ACID AND ELECTROLITHIUM SOLUTION 10% OR AMino ACID SOLUTION CONC. 8.5% WITHOUT ELECTROLITES op. 500 ml 1 /50 Solution for intravenous infusion of trace elements vial 10 ml 5 /2400 ORGANIC PHOSPHATE PREPARATE vial 20 ml, solution for infusion 10 /80 VITAMINS SOLIDS IN FAT AND WATER for intravenous administration for adults . vial 10 /1200 STANDARD AMINOCIMS FOR PATIENTS WITH CHILDREN INFABILITY op. 250 ml 1 /250 STANDARD AMINOCIMS FOR PATIENTS WITH LIBERARY INFABILITY op. 500 ml 10 /100 16.1. LIQUID DIET FOR ORAL DELIVERY FOR PATIENTS WITH CANCER, CONTAINING IMMUNOMODULATORY COMPONENT (OMEGA-3 FATTY ACIDS: EPA 880 MG/100ML AND DHA 585 MG/100ML) AND VITAMIN D 7.85 ΜG/100ML, HYPERCALORIC (2.45 KCAL/ML), PROTEIN CONTENT MIN. 14.6 G/100ML, NON-GMO, GLUTEN-FREE, OSMOLARITY 570 MOSMOL/L, RECOMMENDED FOR CANCER PATIENTS WITH MALNUTRITION OR RISK OF MALNUTRITION ASSOCIATED WITH IT. (MINIMUM OF TWO FACTS TO CHOOSE) bottle. 125 ml 4 /200016.2. LIQUID DIET FOR ORAL DELIVERY TO SUPPORT THE TREATMENT OF DECUBITUS ULCERS AND WOUNDS, COMPLETE, GUTLESS, HYPERCALORIC (1.24 KCAL/ML), GLUTEN-FREE, CONTAINING ARGININE TO ACCELERATE WOUND HEALING, PROTEIN CONTENT 8.8 G/100ML,LOW FAT- 3.5G / 100ML, OSMOLARITY MIN. 500 MOSMOL/L (MINIMUM TWO FACTS TO CHOOSE) bottle. 200 ml 4 /40016.3. HIPERCALORIC (2.4 KCAL/ML), PROTEIN CONTENT 14.4 G/ 100 ML, PROTEIN SOURCES ARE CHAISINE AND CEREAL, FAT-FREE, Glucose-FREE, OSMOLARITY 570 MOSMOL/L, IN EIGHT FACES (MINIMUM OF 4 FACTS TO CHOOSE) bottle. 125 ml 4 /400016.4. GLYCEMIA NORMALIZING, COMPLETE, NORMOCALORIC (1.04 KCAL/ML), NO SACCHAROSE, GLUTEN-FREE, PROTEIN CONTENT NO LESS THAN 4.9G/100ML. WITH AN OSMOLARITY OF 365 MOSMOL/L. (MINIMUM OF TWO FACTS TO CHOOSE) bottle. 200 ml 4 /40016.5. CLARIC LIQUID PREPARATE BASED ON MALTODECTRINE, NO WHITE. FOR USE IN SURGICAL PATIENTS FOR PREOPERATIVE REHYDRATION. CONTAINS CARBOHYDRATES (12.6 G/ 100 ML) AND ELECTROLITES, DRINK-FREE, GLUTEN-FREE, 100% ENERGY FROM CARBOHYDRATES, WITH an OSMOLARITY of 240 MOSMOL/L bottle. 200 ml 4 /60016.6. DIET IN A LINE FOR DOUSNT DRINKING, COMPLETE IN NUTRITION, HIGH ENERGY ( 240KCAL/100ML), CONTAINS FIBER 3.6G/ 100ML, NON-GMO, PROTEIN 9.5G/100ML. bottle. 125 ml 4 /2516.7. PROSPECTED DIET FOR PATIENTS WITH HIGHER PROTEIN REQUIREMENTS WITH A MINIMUM CONTENT OF 87 G PROTEIN/100 G, NON-GLUTENIC it is allowed to offer also foodstuffs for special nutritional use op. 225 g 1 /50016.8. PRODUCT FOR RAPID THICKENING OF LIQUIDS(DRINKS AND FOODS) CONTAINING NO STARCH, GUTEN-FREE, LACTOSE-FREE. op. 175 g 1 /30 HIGH-CALORIC (1.3 KCAL/ML), HIGH-FODGENCY FOOD FOR HUNGRY INFABILITY HIGH CONCENTRATION OF SOLID AMINO ACIDS op.200 ml 1 /500 HIGH-OCALORIC(2.0 KCAL/ML), HIGH-FIBRE DIET, USED IN IN INFABILITY OF THE NECKbut. 200 ml 1 /900 COMPREHENSIVE FOOD FOR NUTRITION, PROTEIN-rich (10G/100ML), HIGH-ENERGY (150KCAL/100ML), OSMOLARITY 385-435 MOSM/L, EPA content 500 MG, DHA 210 MG op. 200 mL 1 /5000 COMPLETE, HIGH-ENERGY (1.5 KCAL/ML), HIGH PROTEIN (MIN. 7.5 G PROTEIN/100 ML), based on PEPTIDES. GODDEN IN MCT, NO LACTOSE, GROSS-FREE, GLUTEN-FREE op. 200 ml 1 /400 HIGH PROTEIN DIET (PROTEIN CONTENT MIN. 25 G/100G), HIGH-ENERGY (4.29 KCAL/1G), NON-NUTRITIOUS WHICH IS A COMPOSITION OF ESSENTIAL NUTRIENTS AND VITAMINS, MICRO- AND MACROELEMENTS, LACTOSE-FREE, GLUTEN-FREE, NON-NUTRITIOUS WITH A NEUTRAL TASTE. 6 /50 22.1 DIET CONTAINING MIN 1.5 KCAL/ML, HIGH PROTEIN (WITH PROTEIN CONTENT MINIMUM 7.5G/100ML), PREPARATION FOR EATING THROUGH A GUIDE FOR PATIENTS WITH DISEASE WITH DISEASE, op. 500 ml 1 /200022.2. COMPREHENSIVE ENTRY-GEATING DIET, calorific value 1.2 KCAL/ML, PREPARED FOR EATING THROUGH A TANK, PREPARED FOR EATING THROUGH A TANK, calorific value 1.2 KCAL/ML, PROTEIN CONTENT NOT LESS THAN 6G/100ML, CONTAINED WITH FISH OIL AND FIBRE, PREPARED FOR EATING THROUGH A TANK Op. 1000 ml 1 /100022.3. COMPREHENSIVE ENTRY-GEATING DIET WITH A CALORICITY OF 2.0 KCAL/ML, PROTEIN CONTENT NOT LESS THAN 10 G/100 ml CONTAINING SINGLE-ASSOCIATED FATTY ACIDS, FISH OIL, MCT, AND FIBER, LOW SODIUM CONTENT Op. 500 ml 1 /40022.4. 1.2 to 1.3 KCAL/ML, HIGH PROTEIN DIET (MIN 10G/100 ML) CONTAINING EPA DHA FATTY ACIDS, PREPARED TO BE FOODED THROUGH A GLOBE op. 500 ml 1 /35022.5. ENORMOUSLY COMPLETE, NUTRITIONALLY NUTRITIONALLY COMPOUNDED, NORMOCALORIC, NORMOBALOTEIN, QUANTITATIVE, FIBRE (1.5G/100ML) op. 500 ml 1 /400022.6. HIPERCALORIC, HIGH-PHYGENIC, HIGH-PHYGENIC (MINIMUM 1.5 KCAL PER 1 ML), HIGH-PHYGENIC (MINIMUM 5.5 G of protein/100ML). op. 500 ml 1 /400022.7. HIGH CALORIC DIET MIN 1.5 KCAL/ML , HIGH PROTEIN (MIN 6G/100 ML) CONTAINING FATTY ACIDS EPA DHA (MIN 0.5G/100ML), PREPARATE FOR FOODING THROUGH A HOLIDGE op. 500 ml 1 /180022.8. NORMOCALORIC, GRADE-FREE, READY-TO-Use, PEPTIDIC DIET - CONTAINS CEREAL PROTEIN HYDROLYSIS; DEDICATED FOR PATIENTS WITH DISABILITIES IN ENRICHMENT AND/OR DIGESTION, PREPARED FOR EATING THROUGH A GUIDE Op. 500 ml 1 /3500 AQUA PRO INIECTIONE op. 250 ml 1 /300 AQUA PRO INIECTIONE op. 0.5 l without PVC with double sterile port and rubber stopper 1 /21 000 AQUA PRO IRRIGATIONE - WATER FOR IRRIGATION op. 500 ml 1 /1 000 AQUA PRO IRRIGATIONE - WATER FOR IRRIGATION op. 1000 ml 1 /1 500 GLUCOSUM 10 % op. 0.5 l without PVC with double sterile port and rubber stopper 1 /1 300 GLUCOSUM 20% op. 0.5 l without PVC with double sterile port and rubber stopper 10 50 GLUCOSUM 40% 500 ml capacity 10 /10 GLUCOSUM 5% op. 0.25 l without PVC with double sterile port and rubber stopper 1 /9 000 GLUCOSUM 5% op. 0.5 l without PVC with double sterile port and rubber stopper 1 /18 000 GLUCOSUM 5 %op. 250 ml without PVC with double sterile port, possibility of injecting 75 ml of the drug, packaging compatible with the system guaranteeing non-contact possibility of preparing cytostatic drugs - the possibility of transferring the drug without using a needle by connecting the syringe in a way guaranteeing safe needle-free luer-lock connection is required. 1 9 000 GLUCOSUM 5 %op. 500 ml without PVC with double sterile port, possibility of injecting 100 ml of the drug, packaging compatible with the system guaranteeing non-contact possibility of preparing cytostatic drugs - the possibility of transferring the drug without using a needle by connecting the syringe in a way guaranteeing a safe needle-free luer-lock connection is required. 1 /9 000 GLUCOSUM 5% 100 ml bag 1 /3 000 GLUCOSUM 5% + NATRII CHLORATUM 0.9% IN A 2:1 COMPOSITION op. 0.5 l without PVC with double sterile port and rubber stopper 1 /2,500 NATRII CHLORIDUM + KALII CHLORIDUM + CALCII CHLORIDUM op. 500 ml 10 /150 NATRII CHLORIDUM + KALII CHLORIDUM + CALCII CHLORIDUM+NATRII LACTAS op. 0.5 l 1 /10 000 NATRII CHLORIDUM 0.9% op 1 l without PVC with double sterile port and rubber stopper 1 /5 000 NATRII CHLORIDUM 0.9% op. 50 ml without PVC with double sterile port and rubber stopper 1 /17 000 NATRII CHLORIDUM 0.9% op. 0.5 l without PVC with double sterile port and rubber stopper 1 /74 0000 NATRII CHLORIDUM 0.9% op. 0.25 l without PVC with double sterile port and rubber stopper 1 74 000 NATRII CHLORIDUM 0.9% op. 0.1 l without PVC with double sterile port and rubber stopper 1 /195 000 NATRII CHLORIDUM 0.9% amp.10ml 50 /5 000 NATRII CHLORIDUM 0.9% op. 250 ml without PVC with double sterile port, possibility of injecting 75 ml of the drug, packaging compatible with the system guaranteeing non-contact possibility of preparing cytostatic drugs - the possibility of transferring the drug without using a needle by connecting the syringe in a way guaranteeing safe needle-free luer-lock connection is required. 1 /32 000 NATRII CHLORIDUM 0.9% op. 100 ml without PVC with double sterile port, possibility of injecting 20 ml of the drug, packaging compatible with the system guaranteeing contact-free preparation of cytostatic drugs - the possibility of transferring the drug without using a needle by connecting the syringe in a way guaranteeing safe needle-free luer-lock connection is required. 1 /18 000 NATRII CHLORIDUM 0.9% op. 500 ml without PVC with double sterile port, possibility of injecting 100 ml of the drug, packaging compatible with the system guaranteeing contact-free preparation of cytostatic drugs - the possibility of transferring the drug without using a needle by connecting the syringe in a way guaranteeing safe needle-free luer-lock connection is required. 1 /30 000 NATRII CHLORIDUM 0.9% op. 50 ml without PVC with double sterile port, possibility of injecting 10 ml of the drug, packaging compatible with the system guaranteeing contact-free preparation of cytostatic drugs - the possibility of transferring the drug without the use of a needle by connecting the syringe in a way guaranteeing a safe needle-free luer-lock connection is required. 1 /10 000 NATRII CHLORIDUM 0.9% op. 1000 ml without PVC with double sterile port, possibility of injecting 120 ml of the drug, packaging compatible with the system guaranteeing non-contact possibility of preparing cytostatic drugs - the possibility of transferring the drug without using a needle by connecting the syringe in a way guaranteeing safe needle-free luer-lock connection is required. 1 /10 000 NATRII CHLORIDUM 0.9% op. 100 ml without pvc with double sterile port and rubber stopper , standing pack 1 /76 000 NATRII CHLORIDUM 0.9% op. 500 ml without PVC with double sterile port and rubber stopper, standing package 10 /15 000 NATRII CHLORIDUM 0.9% sterile flush solution with a spout or a 500 ml pour bottle . 10 /1 000 NATRII CHLORIDUM 0.9% op. 3 l 1 /2 000 NATRII CHLORIDUM 0.9% "sterile solution - stand-up bottle of 1000ml capacity with rubber stopper to be used for flushing during laparoscopic procedures" 1 /500 Intravenous infusion fluid containing salts of magnesium, SODIUM AND POTASSIUM SOLS, CONTAINING CYCTRINATE ANION, WITH OSMOTIC PRESSURE AND IONIC COMPOSITION CLOSE TO THE BLOOD PERIOD Op. 0.5 l without PVC with double sterile port and rubber stopper 1 /10,000 IZOTONIC INFUSION LIQUID, FREE FROM lactates and citrates, FULLY BALANCED AND ADJUSTED TO THE ELECTROLITHIC COMPOSITION OF THE PERCENTAGE Op. 0.5 l without PVC with double sterile port and rubber stopper 1/30,000 Intravenous infusion fluid containing salts of magnesium, sodium and potassium, with an osmotic pressure and ionic composition related to the blood stream op. 0.5 l without PVC with double sterile port and rubber stopper 1 /90,000 4% Concentrated Modified Liquid Gelatin Solution Op. 500 ml 10 /150

Opportunity closing date

27 November 2023

Value of contract

to be confirmed