Bulgaria – Pharmaceutical products – “Supply of antineoplastic medicinal products for the treatment of hematological diseases for the needs of University Hospital ‘Alexandrovska’ EAD”

Opportunity description

Supply of antineoplastic medicinal products for the treatment of hematological diseases for the needs of University Hospital “Alexandrovska” EAD, in accordance with the technical specification. The specification of the medicinal products is divided into 68 lots. Place of performance of the public procurement contract: Hospital Pharmacy of University Hospital “Aleksanrovska” EAD, Sofia, 1 “St. Georgi Sofiyski” St. Period for performance of the public procurement contract: 12 months from the date of conclusion of the contract for the performance of the public procurement contract. Delivery period – no longer than 48 hours, and in urgent cases 24 hours from the date of submission of the request. As of the delivery date, the remaining shelf life must be no less than 40% of that declared by the manufacturer, and for biological medicinal products no less than 25% of that declared by the manufacturer. As of the delivery date, the remaining shelf life must be no less than 40% of that declared by the manufacturer, and for biological medicinal products no less than 25% of that declared by the manufacturer. ATC code / INN /Pharmaceutical form /Unit / /Quantity of active substance /Estimated quantity for 12 months L01EX18-Avapritinib-Film-coated tablet-film-tabl-50 mg-5840 Note: Any specific reference to a standard, specification, technical assessment, technical approval or technical benchmark in these technical specifications shall be deemed supplemented by the words “or equivalent(s)”. Requirements for the medicinal products: 1. The medicinal products must comply with the requirements of the Medicinal Products in Human Medicine Act (MPHMA) – they must possess a valid marketing authorization in the country, issued pursuant to the MPHMA or Regulation (EC) No 726/2004 of the European Parliament and of the Council (Art. 23, para. 1 of the MPHMA). If the marketing authorization for a medicinal product expires during the respective year for which the public procurement procedure is being conducted, the tenderer shall declare, in accordance with Art. 55, para. 6 of the MPHMA, that the quantities of the medicinal products are available. 2. The medicinal products must be included in Annex No 2 to the PLS. The proposed price per package may not be higher than that specified in the annex as the “package value proposed on the basis of the reference value” (pursuant to Art. 55 of the “Ordinance on the terms, rules and procedure for regulating and registering the prices of medicinal products”, amended and supplemented, State Gazette No 8 of 24 January 2017), current as of the deadline for submission of tenders. The proposed price per package may not be higher than the value paid by the NHIF for the same package. The medicinal products must have prices per unit of measure (mg, mcg, etc.) equal to or lower than the prices that the NHIF will pay the medical institution for the specific medicinal product, in accordance with the applicable regulatory framework—the Health Insurance Act, Ordinance No 10 of 2009 on the terms, procedure, mechanism and criteria for payment by the National Health Insurance Fund for medicinal products, medical devices and dietary foods for special medical purposes and for aids, appliances, equipment and medical devices for persons with disabilities, negotiation of discounts and reimbursement of excess funds when applying a mechanism guaranteeing the predictability and sustainability of the NHIF budget, etc. 3. The medicinal products offered under the lots must correspond to the data in the technical and price proposal template from the participation documentation. 4. As of the delivery date, the remaining shelf life must be no less than 40% of that declared by the manufacturer, and for biological medicinal products no less than 25% of that declared by the manufacturer. 5. The medicinal products with which the tenderer participates must have a summary of product characteristics in Bulgarian containing the information under Art. 34, para. 1 of the MPHMA. 6. The packaging of the medicinal products must comply with the requirements of Chapter VI, “Packaging and Package Leaflets of Medicinal Products”, of the MPHMA. ATC code / INN /Pharmaceutical form /Unit / /Quantity of active substance /Estimated quantity for 12 months V03AF03 - Calcium folinate -solution for injection/infusion -fl. -10 mg/ml-10 ml - 21 Note: Any specific reference to a standard, specification, technical assessment, technical approval or technical benchmark in these technical specifications shall be deemed supplemented by the words “or equivalent(s)”. For the Lot, the contract shall enter into force after the quantities of medicinal products under an existing contract concluded following an internal competitive selection conducted by the Contracting Authority under Framework Agreement No РД-11-393/12.09.2025 between the Ministry of Health and the selected contractors have been exhausted. The Contracting Authority shall send written notification to the Contractor regarding the commencement of the contract for the supply of the medicinal product. Requirements for the medicinal products: 1. The medicinal products must comply with the requirements of the Medicinal Products in Human Medicine Act (MPHMA) – they must possess a valid marketing authorization in the country, issued pursuant to the MPHMA or Regulation (EC) No 726/2004 of the European Parliament and of the Council (Art. 23, para. 1 of the MPHMA). If the marketing authorization for a medicinal product expires during the respective year for which the public procurement procedure is being conducted, the tenderer shall declare, in accordance with Art. 55, para. 6 of the MPHMA, that the quantities of the medicinal products are available. 2. The medicinal products must be included in Annex No 2 to the PLS. The proposed price per package may not be higher than that specified in the annex as the “package value proposed on the basis of the reference value” (pursuant to Art. 55 of the “Ordinance on the terms, rules and procedure for regulating and registering the prices of medicinal products”, amended and supplemented, State Gazette No 8 of 24 January 2017), current as of the deadline for submission of tenders. The proposed price per package may not be higher than the value paid by the NHIF for the same package. The medicinal products must have prices per unit of measure (mg, mcg, etc.) equal to or lower than the prices that the NHIF will pay the medical institution for the specific medicinal product, in accordance with the applicable regulatory framework—the Health Insurance Act, Ordinance No 10 of 2009 on the terms, procedure, mechanism and criteria for payment by the National Health Insurance Fund for medicinal products, medical devices and dietary foods for special medical purposes and for aids, appliances, equipment and medical devices for persons with disabilities, negotiation of discounts and reimbursement of excess funds when applying a mechanism guaranteeing the predictability and sustainability of the NHIF budget, etc. 3. The medicinal products offered under the lots must correspond to the data in the technical and price proposal template from the participation documentation. 4. As of the delivery date, the remaining shelf life must be no less than 40% of that declared by the manufacturer, and for biological medicinal products no less than 25% of that declared by the manufacturer. 5. The medicinal products with which the tenderer participates must have a summary of product characteristics in Bulgarian containing the information under Art. 34, para. 1 of the MPHMA. 6. The packaging of the medicinal products must comply with the requirements of Chapter VI, “Packaging and Package Leaflets of Medicinal Products”, of the MPHMA. ATC code / INN /Pharmaceutical form /Unit / /Quantity of active substance /Estimated quantity for 12 months V03AF03 - Calcium folinate - solution for injection - fl. -10 mg/ml-50 ml -10 Note: Any specific reference to a standard, specification, technical assessment, technical approval or technical benchmark in these technical specifications shall be deemed supplemented by the words “or equivalent(s)”. For the Lot, the contract shall enter into force after the quantities of medicinal products under an existing contract concluded following an internal competitive selection conducted by the Contracting Authority under Framework Agreement No РД-11-393/12.09.2025 between the Ministry of Health and the selected contractors have been exhausted. The Contracting Authority shall send written notification to the Contractor regarding the commencement of the contract for the supply of the medicinal product. Requirements for the medicinal products: 1. The medicinal products must comply with the requirements of the Medicinal Products in Human Medicine Act (MPHMA) – they must possess a valid marketing authorization in the country, issued pursuant to the MPHMA or Regulation (EC) No 726/2004 of the European Parliament and of the Council (Art. 23, para. 1 of the MPHMA). If the marketing authorization for a medicinal product expires during the respective year for which the public procurement procedure is being conducted, the tenderer shall declare, in accordance with Art. 55, para. 6 of the MPHMA, that the quantities of the medicinal products are available. 2. The medicinal products must be included in Annex No 2 to the PLS. The proposed price per package may not be higher than that specified in the annex as the “package value proposed on the basis of the reference value” (pursuant to Art. 55 of the “Ordinance on the terms, rules and procedure for regulating and registering the prices of medicinal products”, amended and supplemented, State Gazette No 8 of 24 January 2017), current as of the deadline for submission of tenders. The proposed price per package may not be higher than the value paid by the NHIF for the same package. The medicinal products must have prices per unit of measure (mg, mcg, etc.) equal to or lower than the prices that the NHIF will pay the medical institution for the specific medicinal product, in accordance with the applicable regulatory framework—the Health Insurance Act, Ordinance No 10 of 2009 on the terms, procedure, mechanism and criteria for payment by the National Health Insurance Fund for medicinal products, medical devices and dietary foods for special medical purposes and for aids, appliances, equipment and medical devices for persons with disabilities, negotiation of discounts and reimbursement of excess funds when applying a mechanism guaranteeing the predictability and sustainability of the NHIF budget, etc. 3. The medicinal products offered under the lots must correspond to the data in the technical and price proposal template from the participation documentation. 4. As of the delivery date, the remaining shelf life must be no less than 40% of that declared by the manufacturer, and for biological medicinal products no less than 25% of that declared by the manufacturer. 5. The medicinal products with which the tenderer participates must have a summary of product characteristics in Bulgarian containing the information under Art. 34, para. 1 of the MPHMA. 6. The packaging of the medicinal products must comply with the requirements of Chapter VI, “Packaging and Package Leaflets of Medicinal Products”, of the MPHMA. ATC code / INN /Pharmaceutical form /Unit / /Quantity of active substance /Estimated quantity for 12 months V03AF03 - Calcium folinate - solution for injection - fl. - 10 mg/ml-100 ml - 5 Note: Any specific reference to a standard, specification, technical assessment, technical approval or technical benchmark in these technical specifications shall be deemed supplemented by the words “or equivalent(s)”. For the Lot, the contract shall enter into force after the quantities of medicinal products under an existing contract concluded following an internal competitive selection conducted by the Contracting Authority under Framework Agreement No РД-11-393/12.09.2025 between the Ministry of Health and the selected contractors have been exhausted. The Contracting Authority shall send written notification to the Contractor regarding the commencement of the contract for the supply of the medicinal product. Requirements for the medicinal products: 1. The medicinal products must comply with the requirements of the Medicinal Products in Human Medicine Act (MPHMA) – they must possess a valid marketing authorization in the country, issued pursuant to the MPHMA or Regulation (EC) No 726/2004 of the European Parliament and of the Council (Art. 23, para. 1 of the MPHMA). If the marketing authorization for a medicinal product expires during the respective year for which the public procurement procedure is being conducted, the tenderer shall declare, in accordance with Art. 55, para. 6 of the MPHMA, that the quantities of the medicinal products are available. 2. The medicinal products must be included in Annex No 2 to the PLS. The proposed price per package may not be higher than that specified in the annex as the “package value proposed on the basis of the reference value” (pursuant to Art. 55 of the “Ordinance on the terms, rules and procedure for regulating and registering the prices of medicinal products”, amended and supplemented, State Gazette No 8 of 24 January 2017), current as of the deadline for submission of tenders. The proposed price per package may not be higher than the value paid by the NHIF for the same package. The medicinal products must have prices per unit of measure (mg, mcg, etc.) equal to or lower than the prices that the NHIF will pay the medical institution for the specific medicinal product, in accordance with the applicable regulatory framework—the Health Insurance Act, Ordinance No 10 of 2009 on the terms, procedure, mechanism and criteria for payment by the National Health Insurance Fund for medicinal products, medical devices and dietary foods for special medical purposes and for aids, appliances, equipment and medical devices for persons with disabilities, negotiation of discounts and reimbursement of excess funds when applying a mechanism guaranteeing the predictability and sustainability of the NHIF budget, etc. 3. The medicinal products offered under the lots must correspond to the data in the technical and price proposal template from the participation documentation. 4. As of the delivery date, the remaining shelf life must be no less than 40% of that declared by the manufacturer, and for biological medicinal products no less than 25% of that declared by the manufacturer. 5. The medicinal products with which the tenderer participates must have a summary of product characteristics in Bulgarian containing the information under Art. 34, para. 1 of the MPHMA. 6. The packaging of the medicinal products must comply with the requirements of Chapter VI, “Packaging and Package Leaflets of Medicinal Products”, of the MPHMA. ATC code / INN /Pharmaceutical form /Unit / /Quantity of active substance /Estimated quantity for 12 months L01CB01 - Etoposide - concentrate for solution for infusion - fl. - 20 mg/ml-5 ml - 200 Note: Any specific reference to a standard, specification, technical assessment, technical approval or technical benchmark in these technical specifications shall be deemed supplemented by the words “or equivalent(s)”. Requirements for the medicinal products: 1. The medicinal products must comply with the requirements of the Medicinal Products in Human Medicine Act (MPHMA) – they must possess a valid marketing authorization in the country, issued pursuant to the MPHMA or Regulation (EC) No 726/2004 of the European Parliament and of the Council (Art. 23, para. 1 of the MPHMA). If the marketing authorization for a medicinal product expires during the respective year for which the public procurement procedure is being conducted, the tenderer shall declare, in accordance with Art. 55, para. 6 of the MPHMA, that the quantities of the medicinal products are available. 2. The medicinal products must be included in Annex No 2 to the PLS. The proposed price per package may not be higher than that specified in the annex as the “package value proposed on the basis of the reference value” (pursuant to Art. 55 of the “Ordinance on the terms, rules and procedure for regulating and registering the prices of medicinal products”, amended and supplemented, State Gazette No 8 of 24 January 2017), current as of the deadline for submission of tenders. The proposed price per package may not be higher than the value paid by the NHIF for the same package. The medicinal products must have prices per unit of measure (mg, mcg, etc.) equal to or lower than the prices that the NHIF will pay the medical institution for the specific medicinal product, in accordance with the applicable regulatory framework—the Health Insurance Act, Ordinance No 10 of 2009 on the terms, procedure, mechanism and criteria for payment by the National Health Insurance Fund for medicinal products, medical devices and dietary foods for special medical purposes and for aids, appliances, equipment and medical devices for persons with disabilities, negotiation of discounts and reimbursement of excess funds when applying a mechanism guaranteeing the predictability and sustainability of the NHIF budget, etc. 3. The medicinal products offered under the lots must correspond to the data in the technical and price proposal template from the participation documentation. 4. As of the delivery date, the remaining shelf life must be no less than 40% of that declared by the manufacturer, and for biological medicinal products no less than 25% of that declared by the manufacturer. 5. The medicinal products with which the tenderer participates must have a summary of product characteristics in Bulgarian containing the information under Art. 34, para. 1 of the MPHMA. 6. The packaging of the medicinal products must comply with the requirements of Chapter VI, “Packaging and Package Leaflets of Medicinal Products”, of the MPHMA. ATC code / INN /Pharmaceutical form /Unit / /Quantity of active substance/Estimated quantity L01FX09 - Mogamulizumab - Concentrate for solution for infusion - fl - 4 mg/ml - 5 ml - 104 Note: Any specific reference to a standard, specification, technical assessment, technical approval or technical benchmark in these technical specifications shall be deemed supplemented by the words “or equivalent(s)”. Requirements for the medicinal products: 1. The medicinal products must comply with the requirements of the Medicinal Products in Human Medicine Act (MPHMA) – they must possess a valid marketing authorization in the country, issued pursuant to the MPHMA or Regulation (EC) No 726/2004 of the European Parliament and of the Council (Art. 23, para. 1 of the MPHMA). If the marketing authorization for a medicinal product expires during the respective year for which the public procurement procedure is being conducted, the tenderer shall declare, in accordance with Art. 55, para. 6 of the MPHMA, that the quantities of the medicinal products are available. 2. The medicinal products must be included in Annex No 2 to the PLS. The proposed price per package may not be higher than that specified in the annex as the “package value proposed on the basis of the reference value” (pursuant to Art. 55 of the “Ordinance on the terms, rules and procedure for regulating and registering the prices of medicinal products”, amended and supplemented, State Gazette No 8 of 24 January 2017), current as of the deadline for submission of tenders. The proposed price per package may not be higher than the value paid by the NHIF for the same package. The medicinal products must have prices per unit of measure (mg, mcg, etc.) equal to or lower than the prices that the NHIF will pay the medical institution for the specific medicinal product, in accordance with the applicable regulatory framework—the Health Insurance Act, Ordinance No 10 of 2009 on the terms, procedure, mechanism and criteria for payment by the National Health Insurance Fund for medicinal products, medical devices and dietary foods for special medical purposes and for aids, appliances, equipment and medical devices for persons with disabilities, negotiation of discounts and reimbursement of excess funds when applying a mechanism guaranteeing the predictability and sustainability of the NHIF budget, etc. 3. The medicinal products offered under the lots must correspond to the data in the technical and price proposal template from the participation documentation. 4. As of the delivery date, the remaining shelf life must be no less than 40% of that declared by the manufacturer, and for biological medicinal products no less than 25% of that declared by the manufacturer. 5. The medicinal products with which the tenderer participates must have a summary of product characteristics in Bulgarian containing the information under Art. 34, para. 1 of the MPHMA. 6. The packaging of the medicinal products must comply with the requirements of Chapter VI, “Packaging and Package Leaflets of Medicinal Products”, of the MPHMA. Procedure: open. Estimated value: 14,173,946.12 EUR. Review the original TED notice for the complete requirement, lots, amendments and attachments.