Poland – Antineoplastic agents – Supply of oncology drugs for the Zofia of the Zamoyski Tarnowska Provincial Hospital in Tarnobrzeg

Opportunity description

I. Subject matter of the contract: The subject matter of the contract is the supply of oncology drugs for the Zofia of the Zamoyski Tarnowska Provincial Hospital in Tarnobrzeg, divided into 9 packages. II. Description of the subject matter of the contract: 1. CPV code according to the Common Procurement Vocabulary: 33652100-6 Antineoplastic agents 2. A detailed description of the subject matter of the contract is contained in Appendix No. 2 to the SWZ – Price form. 3. The trade names provided in the SWZ price form are examples. The Contracting Authority permits the submission of equivalent tenders, i.e. pharmaceutically and therapeutically equivalent. Basic concepts and definitions concerning drug bioequivalence issues; modified according to Kaliszan and Janicki. Pharmaceutical equivalence Pharmaceutical equivalence describes a situation in which the compared medicinal products contain the same amount of the medicinal agent in the same (or essentially similar – e.g. tablets, capsules) dosage form, meeting the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not determine therapeutic equivalence, because differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability and, consequently, in the action of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, following their administration at the same dose, their effects in terms of both efficacy and safety are as could have been expected on the basis of appropriate studies. 4. The rules for carrying out the supply in question are specified in the “Draft agreement” constituting Appendix No. 8 to the SWZ. 1. Package 1 – Encorafenibum. 2. A detailed description of the subject matter of the contract is contained in Appendix No. 2 to the SWZ – Price form. 3. The trade names provided in the SWZ price form are examples. The Contracting Authority permits the submission of equivalent tenders, i.e. pharmaceutically and therapeutically equivalent. Basic concepts and definitions concerning drug bioequivalence issues; modified according to Kaliszan and the compared medicinal products contain the same amount of the medicinal agent in the same (or essentially similar – e.g. tablets, capsules) dosage form, meeting the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not determine therapeutic equivalence, because differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability and, consequently, in the action of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, following their administration at the same dose, their effects in terms of both efficacy and safety are as could have been expected on the basis of appropriate studies. 4. The rules for carrying out the supply in question are specified in the “Draft agreement” constituting Appendix No. 8 to the SWZ. 1. Package 2 – Binimetinib. 2. A detailed description of the subject matter of the contract is contained in Appendix No. 2 to the SWZ – Price form. 3. The trade names provided in the SWZ price form are examples. The Contracting Authority permits the submission of equivalent tenders, i.e. pharmaceutically and therapeutically equivalent. Basic concepts and definitions concerning drug bioequivalence issues; modified according to Kaliszan and the compared medicinal products contain the same amount of the medicinal agent in the same (or essentially similar – e.g. tablets, capsules) dosage form, meeting the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not determine therapeutic equivalence, because differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability and, consequently, in the action of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, following their administration at the same dose, their effects in terms of both efficacy and safety are as could have been expected on the basis of appropriate studies. 4. The rules for carrying out the supply in question are specified in the “Draft agreement” constituting Appendix No. 8 to the SWZ. 1. Package 3 – Lazertinib. 2. A detailed description of the subject matter of the contract is contained in Appendix No. 2 to the SWZ – Price form. 3. The trade names provided in the SWZ price form are examples. The Contracting Authority permits the submission of equivalent tenders, i.e. pharmaceutically and therapeutically equivalent. Basic concepts and definitions concerning drug bioequivalence issues; modified according to Kaliszan and the compared medicinal products contain the same amount of the medicinal agent in the same (or essentially similar – e.g. tablets, capsules) dosage form, meeting the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not determine therapeutic equivalence, because differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability and, consequently, in the action of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, following their administration at the same dose, their effects in terms of both efficacy and safety are as could have been expected on the basis of appropriate studies. 4. The rules for carrying out the supply in question are specified in the “Draft agreement” constituting Appendix No. 8 to the SWZ. 1. Package 4 – Serplulimabum. 2. A detailed description of the subject matter of the contract is contained in Appendix No. 2 to the SWZ – Price form. 3. The trade names provided in the SWZ price form are examples. The Contracting Authority permits the submission of equivalent tenders, i.e. pharmaceutically and therapeutically equivalent. Basic concepts and definitions concerning drug bioequivalence issues; modified according to Kaliszan and the compared medicinal products contain the same amount of the medicinal agent in the same (or essentially similar – e.g. tablets, capsules) dosage form, meeting the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not determine therapeutic equivalence, because differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability and, consequently, in the action of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, following their administration at the same dose, their effects in terms of both efficacy and safety are as could have been expected on the basis of appropriate studies. 4. The rules for carrying out the supply in question are specified in the “Draft agreement” constituting Appendix No. 8 to the SWZ. 1. Package 5 – Pemigatinibum. 2. A detailed description of the subject matter of the contract is contained in Appendix No. 2 to the SWZ – Price form. 3. The trade names provided in the SWZ price form are examples. The Contracting Authority permits the submission of equivalent tenders, i.e. pharmaceutically and therapeutically equivalent. Basic concepts and definitions concerning drug bioequivalence issues; modified according to Kaliszan and the compared medicinal products contain the same amount of the medicinal agent in the same (or essentially similar – e.g. tablets, capsules) dosage form, meeting the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not determine therapeutic equivalence, because differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability and, consequently, in the action of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, following their administration at the same dose, their effects in terms of both efficacy and safety are as could have been expected on the basis of appropriate studies. 4. The rules for carrying out the supply in question are specified in the “Draft agreement” constituting Appendix No. 8 to the SWZ. 1. Package 6 – Amivantamabum. 2. A detailed description of the subject matter of the contract is contained in Appendix No. 2 to the SWZ – Price form. 3. The trade names provided in the SWZ price form are examples. The Contracting Authority permits the submission of equivalent tenders, i.e. pharmaceutically and therapeutically equivalent. Basic concepts and definitions concerning drug bioequivalence issues; modified according to Kaliszan and the compared medicinal products contain the same amount of the medicinal agent in the same (or essentially similar – e.g. tablets, capsules) dosage form, meeting the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not determine therapeutic equivalence, because differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability and, consequently, in the action of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, following their administration at the same dose, their effects in terms of both efficacy and safety are as could have been expected on the basis of appropriate studies. 4. The rules for carrying out the supply in question are specified in the “Draft agreement” constituting Appendix No. 8 to the SWZ. 1. Package 7 – Pembolizumab. 2. A detailed description of the subject matter of the contract is contained in Appendix No. 2 to the SWZ – Price form. 3. The trade names provided in the SWZ price form are examples. The Contracting Authority permits the submission of equivalent tenders, i.e. pharmaceutically and therapeutically equivalent. Basic concepts and definitions concerning drug bioequivalence issues; modified according to Kaliszan and the compared medicinal products contain the same amount of the medicinal agent in the same (or essentially similar – e.g. tablets, capsules) dosage form, meeting the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not determine therapeutic equivalence, because differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability and, consequently, in the action of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, following their administration at the same dose, their effects in terms of both efficacy and safety are as could have been expected on the basis of appropriate studies. 4. The rules for carrying out the supply in question are specified in the “Draft agreement” constituting Appendix No. 8 to the SWZ. 1. Package 8 – Obinutuzumab, Trastuzumab, Pertuzumab, Atezolizumab. 2. A detailed description of the subject matter of the contract is contained in Appendix No. 2 to the SWZ – Price form. 3. The trade names provided in the SWZ price form are examples. The Contracting Authority permits the submission of equivalent tenders, i.e. pharmaceutically and therapeutically equivalent. Basic concepts and definitions concerning drug bioequivalence issues; modified according to Kaliszan and the compared medicinal products contain the same amount of the medicinal agent in the same (or essentially similar – e.g. tablets, capsules) dosage form, meeting the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not determine therapeutic equivalence, because differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability and, consequently, in the action of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, following their administration at the same dose, their effects in terms of both efficacy and safety are as could have been expected on the basis of appropriate studies. 4. The rules for carrying out the supply in question are specified in the “Draft agreement” constituting Appendix No. 8 to the SWZ. 1. Package 9 – Tremelimumab. 2. A detailed description of the subject matter of the contract is contained in Appendix No. 2 to the SWZ – Price form. 3. The trade names provided in the SWZ price form are examples. The Contracting Authority permits the submission of equivalent tenders, i.e. pharmaceutically and therapeutically equivalent. Basic concepts and definitions concerning drug bioequivalence issues; modified according to Kaliszan and the compared medicinal products contain the same amount of the medicinal agent in the same (or essentially similar – e.g. tablets, capsules) dosage form, meeting the same comparable standards and intended to be administered by the same route; pharmaceutical equivalence does not determine therapeutic equivalence, because differences in excipients and the manufacturing process may cause differences in dissolution and bioavailability and, consequently, in the action of the pharmaceutical agent. Therapeutic equivalence Two agents are therapeutically equivalent if they are pharmaceutically equivalent and if, following their administration at the same dose, their effects in terms of both efficacy and safety are as could have been expected on the basis of appropriate studies. 4. The rules for carrying out the supply in question are specified in the “Draft agreement” constituting Appendix No. 8 to the SWZ. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.