Poland - Pharmaceutical products

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Details

Provided by Open Opps
Opportunity closing date
23 July 2019
Opportunity publication date
13 June 2019
Category
33600000: Pharmaceutical products
Value of contract
£100k-1m
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Description

1) All doses of parenteral medicinal products with the same international designation listed in a given package must come from a single manufacturer.2) In the event that the Economic Operator becomes aware of a planned cessation of production or an end of marketing authorisation of a medicinal product without a substitute, he is requested to provide such information to the Awarding Entity in order to separate the aforementioned items from the package.3) The Ordering Party requires that the offered medicinal products have EAN codes assigned in accordance with the President's Order No. 56/2018/DGL of 25.6.2018, as amended, and Order No. 125/2017/DGL of 19.12.2017. Failure to meet the above condition will result in rejection of the offer. The EAN code should be entered in the box with the product's trade name, in Annex 1 to the ToR.4) The suitability of the product will be assessed according to the current product characteristics. The Awarding Entity reserves the right to demand the currently valid characteristics of the medicinal product during the examination and evaluation of offers.5) The Awarding Entity requires medicinal products reimbursed by the National Health Fund. This requirement does not apply to medicinal products whose active substances described for a given pharmaceutical form are not included in the list of reimbursed medicines. 1) All doses of parenteral medicinal products with the same international designation listed in a given package must be from a single manufacturer.2) In case the CONTRACTOR has become aware of any intended discontinuation of the manufacturing or marketing authorisation of a medicinal product without a substitute, the CONTRACTOR is requested to provide such information to the CONTRACTOR in order to separate the aforementioned items from the package.3) The Ordering Party requires that the offered medicinal products have EAN codes assigned in accordance with the President's Order No. 56/2018/DGL of 25.06.2018, as amended, and Order No. 125/2017/DGL of 19.12.2017. Failure to meet the above condition will result in rejection of the offer. The EAN code should be entered in the box with the product's trade name, in Annex 1 to the ToR.4) The suitability of the product will be assessed according to the current product characteristics. The ORDER reserves the right to demand the currently valid characteristics of the medicinal product during the examination and evaluation of tenders.5) The ORDER shall require medicinal products reimbursed by the NFZ. This requirement does not apply to medicinal products whose active substances described for a given drug form are not listed in the list of reimbursed drugs.6) Package 2 item 14 ketoprofen 0.1g/2ml - the ORDER requires a medicinal product with registered indications for intravenous use. 1) All doses of parenteral medicinal products with the same international designation listed in a given package must be from a single manufacturer.2) In case the CONTRACTOR has become aware of any intended discontinuation of the manufacturing or marketing authorisation of a medicinal product without a substitute, the CONTRACTOR is requested to provide such information to the CONTRACTOR in order to separate the aforementioned items from the package.3) The Ordering Party requires that the offered medicinal products have EAN codes assigned in accordance with the President's Order No. 56/2018/DGL of 25.06.2018, as amended, and Order No. 125/2017/DGL of 19.12.2017. Failure to meet the above condition will result in rejection of the offer. The EAN code should be entered in the box with the product's trade name, in Annex 1 to the ToR.4) The suitability of the product will be assessed according to the current product characteristics. The ORDER reserves the right to demand the currently valid characteristics of the medicinal product during the examination and evaluation of tenders.5) The ORDER shall require medicinal products reimbursed by the NFZ. This requirement does not apply to medicinal products whose active substances described for a given pharmaceutical form are not included in the list of reimbursed medicines. 1) All doses of parenteral medicinal products with the same international designation listed in a given package must be from a single manufacturer.2) In case the CONTRACTOR has become aware of any intended discontinuation of the manufacturing or marketing authorisation of a medicinal product without a substitute, the CONTRACTOR is requested to provide such information to the CONTRACTOR in order to separate the aforementioned items from the package.3) The Ordering Party requires that the offered medicinal products have EAN codes assigned in accordance with the President's Order No. 56/2018/DGL of 25.06.2018, as amended, and Order No. 125/2017/DGL of 19.12.2017. Failure to meet the above condition will result in rejection of the offer. The EAN code should be entered in the box with the product's trade name, in Annex 1 to the ToR.4) The suitability of the product will be assessed according to the current product characteristics. The ORDER reserves the right to demand the currently valid characteristics of the medicinal product during the examination and evaluation of tenders.5) The ORDER shall require medicinal products reimbursed by the NFZ. This requirement does not apply to medicinal products whose active substances described for a given drug form are not listed in the reimbursement list.6) Package 11, item 11, bupivacaine hydrochloride - The ORDER requires a medicinal product in the form of a 0,5 % solution of Bupivacainum hydrochloricum with the possibility of mixing in one syringe with morphine sulphate and fentanyl as registered in the PGI.7) Package 11, item 12, bupivacainum haevy spinal 0,5 % - The ORDER requires a medicinal product in the form of a 0,5 % hyperbaric solution of bupivacaine in the form of a 0,5 % hyperbaric solution of bupivacaine.) Package No 11, items 39 and 40, lidocaine hydrochloride - CONTRACTOR requires medicinal products in the form of 2 % and 1 % lidocaine solutions respectively with indications for use in intravenous pain treatment registered in the SmPC Perioperative period as a component of preventive and multimodal analgesia in accordance with the latest recommendations for the treatment of postoperative pain.9) Package No. 11 pos. 44 and 45 metamizolum natricum 0,5g/ml - The ORDER requires medicinal products in the form of 0,5g/ml solutions for injections of metamizol with the possibility of mixing with the solution for injections registered in the SmPC Poltram 50mg/ml.10.) Package no. 11 item 81 and 82 tramadol hydrochloride 50mg/ml - Ordering Party requires medicinal products in the form of 50mg/ml solutions for tramadol injection with the possibility of mixing with the solution for injection Pyrrhalgin 0.5g/ml registered in the SmPC. 1) All doses of parenteral medicinal products with the same international designation listed in a given package must be from a single manufacturer.2) In case the CONTRACTOR has become aware of any intended discontinuation of the manufacturing or marketing authorisation of a medicinal product without a substitute, the CONTRACTOR is requested to provide such information to the CONTRACTOR in order to separate the aforementioned items from the package.3) The Ordering Party requires that the offered medicinal products have EAN codes assigned in accordance with the President's Order No. 56/2018/DGL of 25.06.2018, as amended, and Order No. 125/2017/DGL of 19.12.2017. Failure to meet the above condition will result in rejection of the offer. The EAN code should be entered in the box with the product's trade name, in Annex 1 to the ToR.4) The suitability of the product will be assessed according to the current product characteristics. The ORDER reserves the right to demand the currently valid characteristics of the medicinal product during the examination and evaluation of tenders.5) The ORDER shall require medicinal products reimbursed by the NFZ. This requirement does not apply to medicinal products whose active substances described for a given drug form are not listed in the reimbursement list.6) Package 16 Sevofluran - The ORDER requires a pre-mounted sealed filling system for the medicinal product in bottles that provides safety for the patient and medical personnel, without additional connecting elements between the evaporator and the packaging that are compatible with the Vapor 3000 and Draeger Fill filling system in the ORDER's stock; in addition, the ORDER requires the CONTRACTOR to include a statement of commitment free of charge in the CONTRACTOR's tender:a) provide (together with delivery and installation) for the duration of the contract three evaporators compatible with the offered product and with the Draeger anaesthetic devices PRIMUS model, FABIUS PLUS model and FABIUS GS Premium, b) train the staff in the operation of the evaporators provided, c) service and repair of the aforementioned evaporators, d) provide a replacement evaporator for the time of repair.The evaporators shall be delivered immediately after the contract is signed and within the time limit set forth in the ORDER's order. 1) All doses of parenteral medicinal products with the same international designation listed in a given package must be from a single manufacturer.2) In case the CONTRACTOR has become aware of any intended discontinuation of the manufacturing or marketing authorisation of a medicinal product without a substitute, the CONTRACTOR is requested to provide such information to the CONTRACTOR in order to separate the aforementioned items from the package.3) The Ordering Party requires that the offered medicinal products have EAN codes assigned in accordance with the President's Order No. 56/2018/DGL of 25.06.2018, as amended, and Order No. 125/2017/DGL of 19.12.2017. Failure to meet the above condition will result in rejection of the offer. The EAN code should be entered in the box with the product's trade name, in Annex 1 to the ToR.4) The suitability of the product will be assessed according to the current product characteristics. The ORDER reserves the right to demand the currently valid characteristics of the medicinal product during the examination and evaluation of tenders.5) The ORDER shall require medicinal products reimbursed by the NFZ. This requirement does not apply to medicinal products whose active substances described for a given drug form are not listed in the reimbursement list.6) Package No. 17 Desfluran - The ORDER requires the CONTRACTOR to submit a statement with the offer, in which the CONTRACTOR undertakes to provide (together with delivery and installation) for the duration of the agreement, free of charge: a) two evaporators compatible with the product and anaesthetic devices of Draeger model PERSEUS A500; the ORDER requires Vapor 3000 or replacement evaporators with the following functions: Optimal flow selection function ŚG so called "PERSEUS A500" or "PERSEUS A500". Anaesthesia econometer,Anaesthesia econometer,Anaesthetic concentration adjustment support,Anaesthesia prediction function for the following 20 minutes to support minimal flow,Anaesthesia use provided by the evaporator (numerical value),Anaesthetic and gas consumption calculation and presentation per case (anesthesia),b) staff training in the use of the available evaporators,c) maintenance and repair of the aforementioned evaporators,d) provision of a replacement evaporator for the repair time.The evaporators shall be delivered immediately after the signature of the contract and within the time limit agreed with the Purchaser. 1) All doses of parenteral medicinal products with the same international designation listed in a given package must be from a single manufacturer.2) In case the CONTRACTOR has become aware of any intended discontinuation of the manufacturing or marketing authorisation of a medicinal product without a substitute, the CONTRACTOR is requested to provide such information to the CONTRACTOR in order to separate the aforementioned items from the package.3) The Ordering Party requires that the offered medicinal products have EAN codes assigned in accordance with the President's Order No. 56/2018/DGL of 25.06.2018, as amended, and Order No. 125/2017/DGL of 19.12.2017. Failure to meet the above condition will result in rejection of the offer. The EAN code should be entered in the box with the product's trade name, in Annex 1 to the ToR.4) The suitability of the product will be assessed according to the current product characteristics. The ORDER reserves the right to demand the currently valid characteristics of the medicinal product during the examination and evaluation of tenders.5) The ORDER shall require medicinal products reimbursed by the NFZ. This requirement does not apply to medicinal products whose active substances described for a given drug form are not listed in the list of reimbursed drugs.6) Package No. 28, item 5 and 6, fentanyl 0.05 mg/ml - The ORDER requires medicinal products in the form of 0.05 mg/ml of fentanyl solutions with intramuscular, intravenous, subcutaneous, epidural, epidural and subarachnoid routes registered in the SmPC.7) Package No 28, item 7, midazolam 5 mg/ml - CONTRACTOR requires a medicinal product in the form of 5 mg/ml midazolam solution with the possibility registered in the SmPC to be mixed with morphine morphine sulfate Morphini sulfas WZF 20 mg/ml. 1) All doses of parenteral medicinal products with the same international designation listed in a given package must be from a single manufacturer.2) In case the CONTRACTOR has become aware of any intended discontinuation of the manufacturing or marketing authorisation of a medicinal product without a substitute, the CONTRACTOR is requested to provide such information to the CONTRACTOR in order to separate the aforementioned items from the package.3) The Ordering Party requires that the offered medicinal products have EAN codes assigned in accordance with the President's Order No. 56/2018/DGL of 25.06.2018, as amended, and Order No. 125/2017/DGL of 19.12.2017. Failure to meet the above condition will result in rejection of the offer. The EAN code should be entered in the box with the product's trade name, in Annex 1 to the ToR.4) The suitability of the product will be assessed according to the current product characteristics. The ORDER reserves the right to demand the currently valid characteristics of the medicinal product during the examination and evaluation of tenders.5) The ORDER shall require medicinal products reimbursed by the NFZ. The requirement does not apply to medicinal products whose active substances described for a given medicine form are not listed in the list of reimbursed medicines.6) Package no. 39 item 1 - the CONTRACTOR shall attach to the offer catalogue pages containing a description, code number/directory number of the offered medical device and a sample in the amount of 1 pc. The ORDER shall require that the sample be a non-returnable, complete product, which may be used for testing purposes. The sample must be given serial number and expiry date.7) Package no. 39 item 1 - The Ordering Party requires the CONTRACTOR to submit a statement of contents together with the offer: "By submitting an offer in the public procurement procedure No. PN-21/19 for package No. 39, we undertake to deliver a medical device that meets all the requirements specified by law as regards admission to trading and use in the territory of the Republic of Poland, pursuant to the Act of 20 May 2010 on Medical Devices (Journal of Laws of 2019, item 175). At the same time, at the request of the Ordering Party, we undertake to present documents confirming admission to trading on the territory of the Republic of Poland for the offered medical device, including: Declaration of Conformity, Certificate issued by a notified body, if it is necessary to confirm compliance with essential requirements by the offered medical device, Documents confirming that the offered medical device has been reported or notified to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products."During the examination and evaluation of tenders, in case of necessity, the CONTRACTOR reserves the right to demand from the CONTRACTOR current documents listed in the above statement. If the CONTRACTOR fails to present the above-mentioned documents at the Purchaser's request, the offer shall be rejected.

Opportunity closing date
23 July 2019
Value of contract
£100k-1m

About the buyer

Address
Zachodniopomorskie Centrum Onkologii ul. Strzałowska 22 Szczecin 71-730 Poland
Contact
zdudzinski@onkologia.szczecin.pl

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