Delivery of anti-tumor medicinal products for the treatment of hematological diseases, for the needs of UMBAL Alexandrovska EAD Anagrelide -capsule-caps.-0.5 mg

Delivery of anti-tumor medicinal products for the treatment of hematological diseases, for the needs of UMBAL Alexandrovska EAD Anagrelide -capsule-caps.-0.5 mg
ATC code / INN / Pharmaceutical form / Measure / / Amount of active substance / Estimated amount for 12 months L01XX35 - Anagrelide -capsule -caps. -0.5 mg - 47600 Note: Any specific reference to a standard, specification, technical evaluation, technical approval or technical benchmark in these technical specifications should be considered supplemented by the words or equivalent/s. Requirements for medicinal products: 1. Medicinal products must meet the requirements of the Law on Medicinal Products in Human Medicine (ZLPHM) - they must have a valid authorization for use in the country, issued under the order of ZLPHM or Regulation (EC) No. 726/2004. of the European Parliament and the Council (Art. 23, Para. 1 of the ZLPHM). In case of expiry of the authorization for the use of a medicinal product in the relevant year for which the public procurement is held, the participant declares in accordance with Art. 55, para. 6 of the ZLPHM that the quantities of medicinal products are available. 2. Medicinal products should be included in Appendix No. 2 of the PDS. The proposed price for a package cannot be higher than the value of a package offered on the basis of a reference value specified in the appendix (according to Article 55 of the Ordinance on the conditions, rules and procedure for regulating and registering the prices of medicinal products, amended and supplemented SG No. 8 of January 24, 2017), current at the deadline for submitting offers. The proposed price for a package cannot be higher than the value that the NHIF pays for the same package. Medicinal products must have prices per unit of measure (mg, mcg, etc.) equal to or lower than the prices that the NHIF will pay to the medical facility for the specific medication, according to the current regulations - Health Insurance Act, Ordinance No. 10 of 2009 on the conditions, order, mechanism and criteria for payment by the National Health Insurance Fund of medicinal products, medical devices and dietary foods for special medical purposes and aids, devices, equipment and medical devices for people with disabilities, negotiation of discounts and reimbursement of excess funds when implementing a mechanism guaranteeing predictability and sustainability of the NHIF budget, etc. 3. The offered medicinal products under separate positions must correspond to the data from the sample of the technical and price proposal from the participation documentation. 4. As of the date of delivery, 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 participant participates must have a brief description in Bulgarian and containing information under Art. 34, para. 1 of the ZLPHM. 6. The packaging of the medicinal products must meet the requirements of Chapter VI Packaging and Leaflets of Medicinal Products of the Medical Regulations.