657480-2024 - Competition Competition Belgium: Pharmaceutical products Bosutinib Type of procedure: Open Buyer Buyer: AZ Delta vzw Email: procurement@azdelta.be Belgium, Arr. Roeselare (BE256), Roeselare LOT-0001: Bosutinib Pharmaceutical products Belgium, Arr. Roeselare (BE256) Roeselare Belgium, Arr. Tielt (BE257) Tielt Belgium, Arr. Ieper (BE253) Ieper Duration: 48 Months Deadline for receipt of tenders: 25/11/2024 - 10:00:00 (UTC+1) 657480-2024 - Competition Belgium – Pharmaceutical products – Bosutinib OJ S 211/2024 29/10/2024 Contract or concession notice – standard regime Supplies 1. Buyer 1.1. Buyer Official name: AZ Delta vzw Email: procurement@azdelta.be Legal type of the buyer: Body governed by public law Activity of the contracting authority: Health 2. Procedure 2.1. Procedure Title: Bosutinib Description: Deze opdracht omvat het sluiten van een raamovereenkomst voor de levering van bosutinib voor een periode van één jaar en driemaal stilzwijgend verlengbaar voor telkens één jaar. Procedure identifier: 56d84fda-3135-4192-a1ae-90f2bdebf355 Internal identifier: PPP09K-3033/4408/TRI_24_451 Type of procedure: Open 2.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33600000 Pharmaceutical products 2.1.3. Value Maximum value of the framework agreement: 520 720,37 EUR 2.1.4. General information Legal basis: Directive 2014/24/EU 2.1.6. Grounds for exclusion Purely national exclusion grounds: (zie UEA) 5. Lot 5.1. Lot: LOT-0001 Title: Bosutinib Description: Deze opdracht omvat het sluiten van een raamovereenkomst voor de levering van bosutinib voor een periode van één jaar en driemaal stilzwijgend verlengbaar voor telkens één jaar. Internal identifier: TRI_24_451_1 5.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33600000 Pharmaceutical products 5.1.2. Place of performance Postal address: Deltalaan 1 Town: Roeselare Postcode: 8800 Country subdivision (NUTS): Arr. Roeselare (BE256) Country: Belgium Additional information: AZ Delta Campus Rumbeke 5.1.2. Place of performance Postal address: Bruggestraat 84 Town: Tielt Postcode: 8700 Country subdivision (NUTS): Arr. Tielt (BE257) Country: Belgium Additional information: Sint-Andriesziekenhuis Tielt apotheek 5.1.2. Place of performance Postal address: Briekestraat 12 Town: Ieper Postcode: 8900 Country subdivision (NUTS): Arr. Ieper (BE253) Country: Belgium Additional information: Jan Yperman Ziekenhuis apotheek 5.1.3. Estimated duration Duration: 48 Months 5.1.5. Value Maximum value of the framework agreement: 520 720,37 EUR 5.1.6. General information Reserved participation: Participation is not reserved. The names and professional qualifications of the staff assigned to perform the contract must be given: Not required Procurement Project not financed with EU Funds. The procurement is covered by the Government Procurement Agreement (GPA): yes Additional information: Zie vermoedelijke hoeveelheden vermeld in de inventaris + 20%. 5.1.9. Selection criteria Criterion: Type: Technical and professional ability Description: De inschrijver heeft een uitgewerkt beleid van farmacovigilantie. Hij zorgt voor een sluitende traceerbaarheid van het product van grondstof tot eindgebruiker. Hij beheert onder andere alle mogelijke gegevens zoals gemelde bijwerkingen of klachten en heeft een actieplan in geval van problemen die leiden tot een terugroeping en waarschuwing van de reeds behandelde patiënten. (minimumeis)Minimumeisen: Bewijs in de offerte. Criterion: Type: Technical and professional ability Description: De inschrijver heeft een uitgewerkt continuïteitsplan. Hierin staan de preventieve en correctieve maatregelen die de leverbetrouwbaarheid garanderen. Onder preventieve maatregelen begrijpen we o.a. forecast, opvolging verbruikscijfers en niveau van reservevoorraad. De correctieve maatregelen staan beschreven in een noodplan in geval van onderbreking van de productie door een ramp, staking, uitvallen van een machine of andere onvoorziene omstandigheden. (minimumeis)Minimumeisen: 1. Procedure forecast 2. Procedure omtrent de opvolging van de verbruikscijfers 3. Procedure omtrent de reservevoorraad 4. Uitgeschreven noodplan Criterion: Type: Technical and professional ability Description: De inschrijver heeft een uitgewerkt kwaliteitsmanagementsysteem (ISO, GMP en/of andere certificaten) dat hem in staat stelt een kwaliteitsvol product af te leveren. Hij beschrijft de keten van grondstof tot afgewerkt product bij de klant, met de gegevens van de betrokken partijen (producenten, toeleveranciers, distributeurs…) en de manier waarop audits van deze partijen georganiseerd worden. Zo moet ook aangetoond worden dat de kwaliteit van de distributie van de producten gegarandeerd is door de conformiteit aan de Guidelines on Good Distribution Practice of medicinal products for human use (GDP) of gelijkwaardig. De leverancier garandeert om steeds originele producten te leveren en neemt maatregelen om geen vervalste producten in de distributieketen toe te laten. Dit kadert binnen de richtlijn GLD 7.1 van de accreditatienormen voor ziekenhuizen (JCI). (minimumeis)Minimumeisen: Bewijs in de offerte. Criterion: Type: Economic and financial standing Description: Altman Z-score van het laatste boekjaar. Formule: (0,717 x Werkkapitaal / Totale bezittingen) + (0,847 x Totaal van ingehouden winsten / Totale bezittingen) + 3,107 x (Winst voor belastingen en interest / Totale bezittingen) + (0,420 x Boekwaarde van de bezittingen / Boekwaarde van de schulden) + (0,998 x Omzet / Totale bezittingen)Minimumeisen: 1. Berekening wordt weergegeven in de offerte. 2. Score is > 1,23. 3. Document wordt gevalideerd door een erkend boekhouder of revisorenkantoor. Criterion: Type: Suitability to pursue the professional activity Description: * Het UEA, waarmee de ondernemer verklaart dat hij zich niet bevindt in een van de uitsluitingssituaties als bedoeld in de artikelen 67 tot 69 van de wet van 17 juni 2016. Artikel 70 van de wet van 17 juni 2016 betreffende de overheidsopdrachten is van toepassing. Voor de in artikel 67 van de wet bedoelde uitsluitingsgronden deelt de gegadigde of inschrijver op eigen initiatief mee of hij bij het begin van de procedure de in artikel 70, lid 1, bedoelde corrigerende maatregelen heeft genomen. 5.1.10. Award criteria Criterion: Type: Cost Description: Prijs Weight (points, exact): 85 Criterion: Type: Quality Description: Service Weight (points, exact): 10 Criterion: Type: Quality Description: Unit dosis en datamatrix Weight (points, exact): 5 5.1.11. Procurement documents Address of the procurement documents: https://cloud.3p.eu/Downloads/210/6897 5.1.12. Terms of procurement Terms of submission: Electronic submission: Required Address for submission: https://www.publicprocurement.be Languages in which tenders or requests to participate may be submitted: Dutch Electronic catalogue: Not allowed Variants: Not allowed Deadline for receipt of tenders: 25/11/2024 10:00:00 (UTC+1) Deadline until which the tender must remain valid: 90 Days Information about public opening: Opening date: 25/11/2024 10:00:00 (UTC+1) Terms of contract: The execution of the contract must be performed within the framework of sheltered employment programmes: No Electronic invoicing: Required Electronic ordering will be used: no Electronic payment will be used: no Information about review deadlines: De aanbestedende overheid zal een wachttermijn van 15 kalenderdagen in acht nemen tussen deze mededeling en de sluiting van de opdracht, conform artikel 11 van de wet van 17 juni 2013 betreffende de motivering, de informatie en de rechtsmiddelen inzake overheidsopdrachten, bepaalde opdrachten voor werken, leveringen en diensten en concessies. Deze termijn gaat in vanaf de dag die volgt op de datum van de mededeling. Overeenkomstig de artikelen 15, 23 en 24 van de wet van 17 juni 2013 betreffende de motivering, de informatie en de rechtsmiddelen inzake overheidsopdrachten, bepaalde opdrachten voor werken, leveringen en diensten en concessies, kan u binnen een termijn van 15 dagen, vanaf de dag volgend op de verzenddatum van deze kennisgeving, eventueel een vordering tot schorsing indienen bij een rechtscollege. Dit mag uitsluitend gebeuren in het kader van een procedure in kort geding voor de Ondernemingsrechtbank Gent afdeling Kortrijk. Indien wij binnen de toegestane termijn geen schriftelijke kennisgeving in die zin ontvangen, zullen wij de procedure verder zetten. Overeenkomstig de artikelen 14, 23 en 24 van de wet van 17 juni 2013 betreffende de motivering, de informatie en de rechtsmiddelen inzake overheidsopdrachten, bepaalde opdrachten voor werken, leveringen en diensten en concessies, melden wij u dat u zich ook kan richten tot de Ondernemingsrechtbank Gent afdeling Kortrijk, mocht u beroep wensen aan te tekenen tegen deze beslissing. Dit beroep moet op straffe van onontvankelijkheid worden ingediend binnen de 60 dagen na de kennisgeving die u hierbij gedaan wordt. 5.1.15. Techniques Framework agreement: Framework agreement, without reopening of competition Information about the dynamic purchasing system: No dynamic purchase system 5.1.16. Further information, mediation and review Review organisation: Ondernemingsrechtbank Gent afdeling Kortrijk Organisation providing additional information about the procurement procedure: AZ Delta vzw Organisation receiving requests to participate: AZ Delta vzw 8. Organisations 8.1. ORG-0001 Official name: AZ Delta vzw Registration number: 0505931808 Postal address: Deltalaan 1 Town: Roeselare Postcode: 8800 Country subdivision (NUTS): Arr. Roeselare (BE256) Country: Belgium Contact point: Elyn Castelein Email: procurement@azdelta.be Telephone: +32 51237612 Internet address: http://www.azdelta.be/ Buyer profile: https://www.publicprocurement.be Roles of this organisation: Buyer Organisation providing additional information about the procurement procedure Organisation receiving requests to participate 8.1. ORG-0002 Official name: Ondernemingsrechtbank Gent afdeling Kortrijk Registration number: 0308.357.753 Postal address: Beheerstraat 41 Town: Kortrijk Postcode: 8500 Country subdivision (NUTS): Arr. Kortrijk (BE254) Country: Belgium Email: koophandel.gent.rpr.kortrijk@just.fgov.be Telephone: +32 56269601 Roles of this organisation: Review organisation 11. Notice information 11.1. Notice information Notice identifier/version: 71d5088c-8ab5-491c-9919-a7bab98c112c - 01 Form type: Competition Notice type: Contract or concession notice – standard regime Notice subtype: 16 Notice dispatch date: 25/10/2024 00:00:00 (UTC+2) Notice dispatch date (eSender): 25/10/2024 00:00:00 (UTC+2) Languages in which this notice is officially available: Dutch 11.2. Publication information Notice publication number: 657480-2024 OJ S issue number: 211/2024 Publication date: 29/10/2024 Czech document download: https://ted.europa.eu/cs/notice/657480-2024/pdf Danish document download: https://ted.europa.eu/da/notice/657480-2024/pdf German document download: https://ted.europa.eu/de/notice/657480-2024/pdf Greek document download: https://ted.europa.eu/el/notice/657480-2024/pdf Spanish document download: https://ted.europa.eu/es/notice/657480-2024/pdf English document download: https://ted.europa.eu/en/notice/657480-2024/pdf Estonian document download: https://ted.europa.eu/et/notice/657480-2024/pdf Finnish document download: https://ted.europa.eu/fi/notice/657480-2024/pdf French document download: https://ted.europa.eu/fr/notice/657480-2024/pdf Irish document download: https://ted.europa.eu/ga/notice/657480-2024/pdf Croatian document download: https://ted.europa.eu/hr/notice/657480-2024/pdf Hungarian document download: https://ted.europa.eu/hu/notice/657480-2024/pdf Italian document download: https://ted.europa.eu/it/notice/657480-2024/pdf Lithuanian document download: https://ted.europa.eu/lt/notice/657480-2024/pdf Latvian document download: https://ted.europa.eu/lv/notice/657480-2024/pdf Maltese document download: https://ted.europa.eu/mt/notice/657480-2024/pdf Dutch document download: https://ted.europa.eu/nl/notice/657480-2024/pdf Polska document download: https://ted.europa.eu/pl/notice/657480-2024/pdf Portuguese document download: https://ted.europa.eu/pt/notice/657480-2024/pdf Romanian document download: https://ted.europa.eu/ro/notice/657480-2024/pdf Slovak document download: https://ted.europa.eu/sk/notice/657480-2024/pdf Slovenian document download: https://ted.europa.eu/sl/notice/657480-2024/pdf Swedish document download: https://ted.europa.eu/sv/notice/657480-2024/pdf Bulgarian document download: https://ted.europa.eu/bg/notice/657480-2024/pdf

657480-2024 - Competition Competition Belgium: Pharmaceutical products Bosutinib Type of procedure: Open Buyer Buyer: AZ Delta vzw Email: procurement@azdelta.be Belgium, Arr. Roeselare (BE256), Roeselare LOT-0001: Bosutinib Pharmaceutical products Belgium, Arr. Roeselare (BE256) Roeselare Belgium, Arr. Tielt (BE257) Tielt Belgium, Arr. Ieper (BE253) Ieper Duration: 48 Months Deadline for receipt of tenders: 25/11/2024 - 10:00:00 (UTC+1) 657480-2024 - Competition Belgium – Pharmaceutical products – Bosutinib OJ S 211/2024 29/10/2024 Contract or concession notice – standard regime Supplies 1. Buyer 1.1. Buyer Official name: AZ Delta vzw Email: procurement@azdelta.be Legal type of the buyer: Body governed by public law Activity of the contracting authority: Health 2. Procedure 2.1. Procedure Title: Bosutinib Description: This contract concerns the conclusion of a framework agreement for the supply of bosutinib for a period of one year, tacitly renewable three times for one year each time. Procedure identifier: 56d84fda-3135-4192-a1ae-90f2bdebf355 Internal identifier: PPP09K-3033/4408/TRI_24_451 Type of procedure: Open 2.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33600000 Pharmaceutical products 2.1.3. Value Maximum value of the framework agreement: 520 720,37 EUR 2.1.4. General information Legal basis: Directive 2014/24/EU 2.1.6. Grounds for exclusion Purely national exclusion grounds: (see UEA) 5. Lot 5.1. Lot: LOT-0001 Title: Bosutinib Description: This contract concerns the conclusion of a framework agreement for the supply of bosutinib for a period of one year, tacitly renewable three times for one year each time. Internal identifier: TRI_24_451_1 5.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33600000 Pharmaceutical products 5.1.2. Place of performance Postal address: Deltalaan 1 Town: Roeselare Postcode: 8800 Country subdivision (NUTS): Arr. Roeselare (BE256) Country: Belgium Additional information: AZ Delta Campus Rumbeke 5.1.2. Place of performance Postal address: Bruggestraat 84 Town: Tielt Postal code: 8700 Country subdivision (NUTS): Arr. Tielt (BE257) Country: Belgium Additional information: Sint-Andriesziekenhuis Tielt pharmacy 5.1.2. Place of performance Postal address: Briekestraat 12 Town: Ypres Postal code: 8900 Country subdivision (NUTS): Arr. Ypres (BE253) Country: Belgium Additional information: Jan Yperman Hospital pharmacy 5.1.3. Estimated duration Duration: 48 Months 5.1.5. Value Maximum value of the framework agreement: EUR 520,720.37 5.1.6. General information Reserved participation: Participation is not reserved. The names and professional qualifications of the staff assigned to perform the contract must be given: Not required Procurement Project not financed with EU Funds. The procurement is covered by the Government Procurement Agreement (GPA): yes Additional information: See estimated quantities stated in the inventory + 20%. 5.1.9.Selection criteria Criterion: Type: Technical and professional ability Description: The tenderer has a detailed pharmacovigilance policy. He ensures complete traceability of the product from raw material to end user. He manages, among other things, all possible data such as reported side effects or complaints and has an action plan in the event of problems that lead to a recall and warning of patients already treated. (minimum requirement)Minimum requirements: Evidence in the quotation. Criterion: Type: Technical and professional ability Description: The tenderer has a detailed continuity plan. This contains the preventive and corrective measures that guarantee delivery reliability. Preventive measures include forecast, monitoring of consumption figures and reserve stock level. The corrective measures are described in an emergency plan in the event of interruption of production due to a disaster, strike, machine failure or other unforeseen circumstances. (minimum requirement)Minimum requirements: 1. Forecast procedure 2. Procedure for monitoring consumption figures 3. Procedure for reserve stock 4. Written emergency plan Criterion: Type: Technical and professional ability Description: The tenderer has a detailed quality management system (ISO, GMP and/or other certificates) that enables him to deliver a quality product. He describes the chain from raw material to finished product at the customer, with the details of the parties involved (producers, suppliers, distributors, etc.) and the way in which audits of these parties are organised. It must also be demonstrated that the quality of the distribution of the products is guaranteed by conformity with the Guidelines on Good Distribution Practice of medicinal products for human use (GDP) or equivalent. The supplier guarantees to always deliver original products and takes measures to prevent counterfeit products from entering the distribution chain. This is part of the GLD 7.1 guideline of the accreditation standards for hospitals (JCI). (minimum requirement)Minimum requirements: Proof in the quotation. Criterion: Type: Economic and financial standing Description: Altman Z-score of the last financial year. Formula: (0.717 x Working capital / Total assets) + (0.847 x Total retained earnings / Total assets) + 3.107 x (Profit before tax and interest / Total assets) + (0.420 x Book value of assets / Book value of liabilities) + (0.998 x Turnover / Total assets)Minimum requirements: 1. Calculation is shown in the offer. 2. Score is > 1.23. 3. Document is validated by a certified accountant or audit firm. Criterion: Type: Suitability to pursue the professional activity Description: * The UEA, with which the entrepreneur declares that he is not in one of the exclusion situations referred to in Articles 67 to 69 of the Act of 17 June 2016.Article 70 of the Act of 17 June 2016 on public procurement applies. For the grounds for exclusion referred to in Article 67 of the Act, the candidate or tenderer shall indicate on his own initiative whether he has taken the corrective measures referred to in Article 70, paragraph 1, at the start of the procedure. 5.1.10. Award criteria Criterion: Type: Cost Description: Price Weight (points, exact): 85 Criterion: Type: Quality Description: Service Weight (points, exact): 10 Criterion: Type: Quality Description: Unit dose and data matrix Weight (points, exact): 5 5.1.11. Procurement documents Address of the procurement documents: https://cloud.3p.eu/Downloads/210/6897 5.1.12. Terms of procurement Terms of submission: Electronic submission: Required Address for submission: https://www.publicprocurement.be Languages ​​in which tenders or requests to participate may be submitted: Dutch Electronic catalogue: Not allowed Variants: Not allowed Deadline for receipt of tenders: 25/11/2024 10:00:00 (UTC+1) Deadline until which the tender must remain valid: 90 Days Information about public opening: Opening date: 25/11/2024 10:00:00 (UTC+1) Terms of contract: The execution of the contract must be performed within the framework of sheltered employment programmes: No Electronic invoicing: Required Electronic ordering will be used: no Electronic payment will be used: no Information about review deadlines: The contracting authority will observe a waiting period of 15 calendar days between this notification and the conclusion of the contract, in accordance with Article 11 of the Act of 17 June 2013 on motivation, information and remedies for public contracts, certain contracts for works, supplies and services and concessions. This period commences on the day following the date of the notification. In accordance with Articles 15, 23 and 24 of the Act of 17 June 2013 on the motivation, information and legal remedies for public contracts, certain contracts for works, supplies and services and concessions, you may, within a period of 15 days, from the day following the date of dispatch of this notification, file a request for suspension with a court. This may only be done in the context of summary proceedings before the Enterprise Court of Ghent, Kortrijk division. If we do not receive written notice to that effect within the permitted period, we will continue the procedure. In accordance with Articles 14, 23 and 24 of the Act of 17 June 2013 on the motivation, information and legal remedies for public contracts, certain contracts for works, supplies and services and concessions, we inform you that you can also contact the Ghent Enterprise Court, Kortrijk division, if you wish to appeal against this decision.This appeal must be filed, under penalty of inadmissibility, within 60 days of the notice hereby given to you. 5.1.15. Techniques Framework agreement: Framework agreement, without reopening of competition Information about the dynamic purchasing system: No dynamic purchase system 5.1.16. Further information, mediation and review Review organisation: Ondernemingsrechtbank Gent afdeling Kortrijk Organisation providing additional information about the procurement procedure: AZ Delta vzw Organisation receiving requests to participate: AZ Delta vzw 8. Organisations 8.1. ORG-0001 Official name: AZ Delta vzw Registration number: 0505931808 Postal address: Deltalaan 1 Town: Roeselare Postcode: 8800 Country subdivision (NUTS): Arr. Roeselare (BE256) Country: Belgium Contact point: Elyn Castelein Email: procurement@azdelta.be Telephone: +32 51237612 Internet address: http://www.azdelta.be/ Buyer profile: https://www.publicprocurement.be Roles of this organization: Buyer Organization providing additional information about the procurement procedure Organization receiving requests to participate 8.1. ORG-0002 Official name: Enterprise Court Ghent department Kortrijk Registration number: 0308.357.753 Postal address: Beheerstraat 41 Town: Kortrijk Postal code: 8500 Country subdivision (NUTS): Arr. Kortrijk (BE254) Country: Belgium Email: koophandel.gent.rpr.kortrijk@just.fgov.be Telephone: +32 56269601 Roles of this organization: Review organization 11. Notice information 11.1. Notice information Notice identifier/version: 71d5088c-8ab5-491c-9919-a7bab98c112c - 01 Form type: Competition Notice type: Contract or concession notice – standard regime Notice subtype: 16 Notice dispatch date: 25/10/2024 00:00:00 (UTC+2) Notice dispatch date (eSender): 25/10/2024 00:00:00 (UTC+2) Languages ​​in which this notice is officially available: Dutch 11.2. Publication information Notice publication number: 657480-2024 OJ S issue number: 211/2024 Publication date: 29/10/2024 Czech document download: https://ted.europa.eu/cs/notice/657480-2024/pdf Danish document download: https://ted.europa.eu/da/notice/657480-2024/pdf German document download: https://ted.eur opa.eu/de/notice/657480-2024/pdf Greek document download: https://ted.europa.eu/el/notice/657480-2024/pdf Spanish document download: https://ted.europa.eu/es/notice/657480-2024/pdf English document download: https://ted.europa.eu/en/notice/657480-2024/pdf Estonian document download : https://ted.europa.eu/et/notice/657480-2024/pdf Finnish document download: https://ted.europa.eu/fi/notice/657480-2024/pdf French document download: https://ted.europa.eu/fr/notice/657480-2024/pdf Irish document download: https://ted.europa.eu/ga/notice/657480-2024 /pdf Croatian document download: https://ted.europa.eu/hr/notice/657480-2024/pdf Hungarian document download: https://ted.europa.eu/hu/notice/657480-2024/pdf Italian document download: https://ted.europa.eu/it/notice/657480-2024/pdf Lithuanian document download:https://ted.europa.eu/lt/notice/657480-2024/pdf Latvian document download: https://ted.europa.eu/lv/notice/657480-2024/pdf Maltese document download: https:// ted.europa.eu/mt/notice/657480-2024/pdf Dutch document download: https://ted.europa.eu/nl/notice/657480-2024/pdf Polska document download: https://ted.europa. eu/pl/notice/657480-2024/pdf Portuguese document download: https://ted.europa.eu/pt/notice/657480-2024/pdf Romanian document download: https://ted.europa.eu/ro/ notice/657480-2024/pdf Slovak document download: https://ted.europa.eu/sk/notice/657480-2024/pdf Slovenian document download: https://ted.europa.eu/sl/notice/657480-2024/pdf Swedish document download: https:// ted.europa.eu/sv/notice/657480-2024/pdf Bulgarian document download: https://ted.europa.eu/bg/notice/657480-2024/pdf