Poland - Antiviral agents for systemic use

Description

1. The subject of the order is the supply of antiretroviral drugs with delivery to the depot: Part 1: Bictegravir/Emtricitabine/Tenofovir Alafenamide | 50/200/25mg | tablet | 30Part 2: Dolutegravir/Lamivudine | 50/300mg | tablet | 30Part 3: Dolutegravir | 5mg | tablet | 60Part 4: Abacavir | 300mg | tablet | 60In accordance with the description of the object of the order specified in the Terms of Reference (SWZ): Dolutegravir | 5mg | tablet | 60Part 4: Abacavir | 300mg | tablet | 60According to the description of the subject of the contract specified in the SWZ and under the conditions specified in the draft provisions of the contract, which constitute an annex to the SWZ.
1International, chemical name of medicinal product:Bictegravir/Emtricitabine/Tenofovir AlafenamidePotency or volume: 50/200/25mgPharmaceutical form: tabletPack size: 30Number of packages: 53002.SUBJECT EVIDENCE:2.1 Pursuant to Articles 105 and 106 of the PPL Act, in order to confirm the compliance of the supplies offered with the requirements, characteristics or criteria specified in the description of the subject matter of the contract or the criteria for evaluation of tenders or the requirements related to the performance of the contract, the Contracting Authority shall require the contractors to present the following documents:2.1.1 A valid marketing authorization issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or a valid marketing authorization issued by the Council of the European Union or the European Commission, valid as of the date of submitting the tenders:2.2 The Purchaser shall allow for the possibility of offering the subject matter of the contract in foreign language packaging. The Contractor must provide at least one instruction in Polish attached to the packaging concerning the storage and handling of the subject matter of the contract and a copy of the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to the total or partial exemption from the obligation to prepare the labelling of the packaging and the package leaflet in Polish or a confirmation of submission of an application for such consent. If such consent is obtained, the Economic Operator shall provide the Contracting Authority with a copy of the consent no later than on the date of signing the contract.2.3. the aforementioned documents must be valid for the entire period of performance of the contract.2.4. if the validity of a document expires, the Economic Operator shall provide the Contracting Authority, together with the documents referred to in item 2.1, with an additional document stating that an application has been submitted in due time for extension of the validity of the marketing authorisation for the medicinal product or, if such an application is granted, a valid marketing authorisation for the medicinal product.2.5 Pursuant to Article 107, item 1 of the PPL Act the Economic Operator shall submit the above mentioned means of evidence together with the tender and shall take all the necessary care to ensure that the said documents are complete and contain all the necessary information to enable the Contracting Authority to verify their correctness.2.6 The Contracting Authority, pursuant to Article 107, item 2 of the PPL Act, shall allow the above mentioned means of evidence to be supplemented once within the time limit specified by the Contracting Authority. 2.7. The evidence referred to above shall be submitted in the manner prescribed in provisions issued pursuant to Article 70 of the PPL Act, i.e. in the Ordinance of the President of the Council of Europe on the conditions for filing an application for the award of a patent. - i.e. in the Regulation of the President of the Council of Ministers of 30 December 2020 on the manner of preparing and submitting information and technical requirements for electronic documents and means of electronic communication in public procurement proceedings or in a competition.2.8 Documents prepared in a foreign language shall be submitted together with a translation into Polish. 1 International, chemical name of the medicinal product:Dolutegravir/LamivudinePotency or volume: 50/300mgPharmaceutical form: tabletPackage size: 30Number of packages: 30002.SUBJECT EVIDENCE:2.1. Pursuant to Articles 105 and 106 of the PPL Act, in order to confirm the compliance of the supplies offered with the requirements, characteristics or criteria specified in the description of the subject matter of the contract or the criteria for evaluation of tenders or the requirements related to the performance of the contract, the Contracting Authority shall require contractors to present the following documents:2.1.1 A valid marketing authorization issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or a valid marketing authorization issued by the Council of the European Union or the European Commission, valid as of the date of submitting the tenders:2.2 The Purchaser shall allow for the possibility of offering the subject matter of the contract in foreign language packaging. The Contractor must provide at least one instruction in Polish attached to the packaging concerning the storage and handling of the subject matter of the contract and a copy of the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to the total or partial exemption from the obligation to prepare the labelling of the packaging and the package leaflet in Polish or a confirmation of submission of an application for such consent. If such consent is obtained, the Economic Operator shall provide the Contracting Authority with a copy of the consent no later than on the date of signing the contract.2.3. the aforementioned documents must be valid for the entire period of performance of the contract.2.4. if the validity of a document expires, the Economic Operator shall provide the Contracting Authority, together with the documents referred to in item 2.1, with an additional document stating that an application has been submitted in due time for extension of the validity of the marketing authorisation for the medicinal product or, if such an application is granted, a valid marketing authorisation for the medicinal product.2.5 Pursuant to Article 107, item 1 of the PPL Act the Economic Operator shall submit the above mentioned means of evidence together with the tender and shall take all the necessary care to ensure that the said documents are complete and contain all the necessary information to enable the Contracting Authority to verify their correctness.2.6 The Contracting Authority, pursuant to Article 107, item 2 of the PPL Act, shall allow the above mentioned means of evidence to be supplemented once within the time limit specified by the Contracting Authority. 2.7. The evidence referred to above shall be submitted in the manner prescribed in provisions issued pursuant to Article 70 of the PPL Act, i.e. in the Ordinance of the President of the Council of Europe on the conditions for filing an application for the award of a patent. - i.e. in the Regulation of the President of the Council of Ministers of 30 December 2020 on the manner of preparing and submitting information and technical requirements for electronic documents and means of electronic communication in public procurement proceedings or in a competition.2.8 Documents prepared in a foreign language shall be submitted together with a translation into Polish. 1.International, chemical name of the medicinal product:DolutegravirPotency or volume: 5mgPharmaceutical form: tabletPackage size: 60Number of packages: 152.SUBJECT EVIDENCE:2.1 Pursuant to Articles 105 and 106 of the PPL Act, in order to confirm the compliance of the supplies offered with the requirements, characteristics or criteria specified in the description of the subject matter of the contract or the criteria for evaluation of tenders or the requirements related to the performance of the contract, the Contracting Authority shall require the contractors to present the following documents:2.1.1 A valid marketing authorization issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or a valid marketing authorization issued by the Council of the European Union or the European Commission, valid as of the date of submitting the tenders:2.2 The Purchaser shall allow for the possibility of offering the subject matter of the contract in foreign language packaging. The Contractor must provide at least one instruction in Polish attached to the packaging concerning the storage and handling of the subject matter of the contract and a copy of the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to the total or partial exemption from the obligation to prepare the labelling of the packaging and the package leaflet in Polish or a confirmation of submission of an application for such consent. If such consent is obtained, the Economic Operator shall provide the Contracting Authority with a copy of the consent no later than on the date of signing the contract.2.3. the aforementioned documents must be valid for the entire period of performance of the contract.2.4. if the validity of a document expires, the Economic Operator shall provide the Contracting Authority, together with the documents referred to in item 2.1, with an additional document stating that an application has been submitted in due time for extension of the validity of the marketing authorisation for the medicinal product or, if such an application is granted, a valid marketing authorisation for the medicinal product.2.5 Pursuant to Article 107, item 1 of the PPL Act the Economic Operator shall submit the above mentioned means of evidence together with the tender and shall take all the necessary care to ensure that the said documents are complete and contain all the necessary information to enable the Contracting Authority to verify their correctness.2.6 The Contracting Authority, pursuant to Article 107, item 2 of the PPL Act, shall allow the above mentioned means of evidence to be supplemented once within the time limit specified by the Contracting Authority. 2.7. The evidence referred to above shall be submitted in the manner prescribed in provisions issued pursuant to Article 70 of the PPL Act, i.e. in the Ordinance of the President of the Council of Europe on the conditions for filing an application for the award of a patent. - i.e. in the Regulation of the President of the Council of Ministers of 30 December 2020 on the manner of preparing and submitting information and technical requirements for electronic documents and means of electronic communication in public procurement proceedings or in a competition.2.8 Documents prepared in a foreign language shall be submitted together with a translation into Polish. 1. international, chemical name of the medicinal product:AbacavirPotency or volume: 300mgPharmaceutical form: tabletPack size: 60Number of packages: 1502.SUBJECT EVIDENCE:2.1 Pursuant to Articles 105 and 106 of the PPL Act, in order to confirm the compliance of the supplies offered with the requirements, characteristics or criteria specified in the description of the subject matter of the contract or the criteria for evaluation of tenders or the requirements related to the performance of the contract, the Contracting Authority shall require the contractors to present the following documents:2.1.1 A valid marketing authorization issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or a valid marketing authorization issued by the Council of the European Union or the European Commission, valid as of the date of submitting the tenders:2.2 The Purchaser shall allow for the possibility of offering the subject matter of the contract in foreign language packaging. The Contractor must provide at least one instruction in Polish attached to the packaging concerning the storage and handling of the subject matter of the contract and a copy of the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to the total or partial exemption from the obligation to prepare the labelling of the packaging and the package leaflet in Polish or a confirmation of submission of an application for such consent. If such consent is obtained, the Economic Operator shall provide the Contracting Authority with a copy of the consent no later than on the date of signing the contract.2.3. the aforementioned documents must be valid for the entire period of performance of the contract.2.4. if the validity of a document expires, the Economic Operator shall provide the Contracting Authority, together with the documents referred to in item 2.1, with an additional document stating that an application has been submitted in due time for extension of the validity of the marketing authorisation for the medicinal product or, if such an application is granted, a valid marketing authorisation for the medicinal product.2.5 Pursuant to Article 107, item 1 of the PPL Act the Economic Operator shall submit the above mentioned means of evidence together with the tender and shall take all the necessary care to ensure that the said documents are complete and contain all the necessary information to enable the Contracting Authority to verify their correctness.2.6 The Contracting Authority, pursuant to Article 107, item 2 of the PPL Act, shall allow the above mentioned means of evidence to be supplemented once within the time limit specified by the Contracting Authority. 2.7. The evidence referred to above shall be submitted in the manner prescribed in provisions issued pursuant to Article 70 of the PPL Act, i.e. in the Ordinance of the President of the Council of Europe on the conditions for filing an application for the award of a patent. - i.e. in the Regulation of the President of the Council of Ministers of 30 December 2020 on the manner of preparing and submitting information and technical requirements for electronic documents and means of electronic communication in public procurement proceedings or the competition.2.8. Documents prepared in a foreign language shall be submitted together with a translation into Polish.

Opportunity closing date

26 November 2021

Value of contract

to be confirmed