657018-2024 - Competition Competition Norway: Pharmaceutical products 2599a HAE disease Norway, Anywhere in the given country Estimated value excluding VAT: 375 000 000,00 NOK Type of procedure: Open Buyer Buyer: SYKEHUSINNKJØP HF Email: post@sykehusinnkjop.no Norway, Troms og Finnmark (NO074), VADSØ LOT-0000: 2599a HAE disease Pharmaceutical products Norway, Anywhere in the given country Start date: 31/01/2025 Duration end date: 31/01/2026 Estimated value excluding VAT: 375 000 000,00 NOK Deadline for receipt of tenders: 02/12/2024 - 11:00:00 (UTC) 657018-2024 - Competition Norway – Pharmaceutical products – 2599a HAE disease OJ S 211/2024 29/10/2024 Contract or concession notice – standard regime Supplies 1. Buyer 1.1. Buyer Official name: SYKEHUSINNKJØP HF Email: post@sykehusinnkjop.no Legal type of the buyer: Body governed by public law Activity of the contracting authority: Health 2. Procedure 2.1. Procedure Title: 2599a HAE disease Description: The contracting authority for this competition is Sykehusinnkjøp HF, on behalf of the four regional health authorities in Norway: Helse Sør-Øst RHF, Helse Vest RHF, Helse Midt-Norway RHF and Helse Nord RHF. Procedure identifier: 0f4157b5-a5db-4bd8-815e-88f15bd520b2 Internal identifier: 2024/353 Type of procedure: Open The procedure is accelerated: no Main features of the procedure: The contracting authority shall, on behalf of the four regional health authorities in Norway enter into framework agreements for active substances connected to HAE disease. See Annex 3 Requirement Specifications and The Competition Provisions for detailed information. The active ingredient Icatibant (B06AC02) under the framework agreement 2499a has been extended to 31.01.2026. Icatibant will therefore not be a part of 2599a, but will be included in the next HAE procurement. 2.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33600000 Pharmaceutical products 2.1.2. Place of performance Country: Norway Anywhere in the given country 2.1.3. Value Estimated value excluding VAT: 375 000 000,00 NOK 2.1.4. General information Legal basis: Directive 2014/24/EU Anskaffelsesforskriften - 2.1.6. Grounds for exclusion Analogous situation like bankruptcy under national law: Is the supplier in a situation where he has been forced debt arrangement? Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions. Bankruptcy: Is the tenderer in a bankruptcy situation? Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions. Corruption: Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, in the event a enforceable verdict has been convicted of corruption by a verdict handed down not more than five years ago, or a rejection period determined directly in the judgement that still applies? Corruption as defined in Article 3 of the Convention on Combating Corruption, Involving European Communities or European Union Member States (EUT C 195 of 25.6.1997, s. 1), and in Article 2, point 1, in the Council ́s framework decision 2003/568/RIA of 22 July 2003 on combating corruption in the private sector (EUT L 192 of 31.7.2003, p. 54). This rejection reason also includes corruption as defined in national law for the contracting authority or supplier. Arrangement with creditors: Is the supplier in a situation where he has been forced debt arrangement? Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions. Participation in a criminal organisation: Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, at the time a legally convicted verdict of participation in a criminal organisation by a verdict handed down no more than five years ago, or a rejection period set out directly in the judgement that still applies? Participation in a criminal organisation as defined in Article 2 of the Council ́s framework decision 2008/841/RIA of 24 October 2008 on control of organised crime (EUT L 300 of 11.11.2008, p. 42) Agreements with other economic operators aimed at distorting competition: Has the tenderer entered into agreement(s) with other tenderers with the intention of turning the competition? Money laundering or terrorist financing: Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, in the event a legal verdict has been convicted of money laundering or financing terrorism by a verdict handed down no more than five years ago, or a rejection period set out directly in the judgement that still applies? Money laundering or financing terrorism As defined in Article 1 of the European Parliament and Council Directive 2005/60/EF of 26 October 2005 on preventive measures against the use of the financial system for money laundering and financing terrorism (EUT L 309 of 25.11.2005, p. 15). Fraud: Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, at the time a legally convicted of fraud has been convicted of fraud by a verdict handed down not more than five years ago, or a rejection period determined directly in the judgement that still applies? Fraud included in Article 1 of the Convention on protection of the Financial Interests of the European Communities (EFT C 316 of 27.11.1995, p. 48). Child labour and other forms of trafficking in human beings: Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, in the event a legal verdict has been convicted of child labour and other forms of human trafficking by a verdict handed down no more than five years ago, or a rejection period determined directly in the judgement that still applies? Child labour and other forms of human trafficking as defined in Article 2 of the European Parliament and council directive 2011/36/EU of 5. 1 April 2011 on the prevention and control of human trafficking and the protection of its victims and for compensation of the Council ́s framework decision 2002/629/RIA (EUT L 101 of 15.4.2011, p. 1). Insolvency: Is the tenderer in an insolvency situation? Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions. Assets being administered by liquidator: Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions. Guilty of misrepresentation, withheld information, unable to provide required documents and obtained confidential information of this procedure: Have the tenderer:a) given grossly incorrect information when notifying the information required to verify that there is no basis for rejection, or of the qualification requirements being met,b) failed to provide such information,c) subject to immediately submitting the supporting documents requested by the Contracting Authority, ord) improperly affecting the Contracting Authority's decision process to acquire confidential information that could give this an unlawful advantage in connection with competition, or negligently has given misleading information that can have a significant influence on decisions on rejection, selection or award? Purely national exclusion grounds: The contracting authority shall state that in Norway there are national rejection reasons. These shall be described in the procurement documents. Tenderers must respond to whether they are in one or more of the situations described in the national rejection reasons. Will the purely national rejection reasons, as stated in the relevant notice or in the procurement documents, apply? Conflict of interest due to its participation in the procurement procedure: Are tenderers aware of a conflict of interest as stated in national law, the relevant notice or procurement documents? Direct or indirect involvement in the preparation of this procurement procedure: Has the tenderer or an entity associated with the supplier advised the contracting authority or in another way been involved in the planning of the competition? Guilty of grave professional misconduct: Has the tenderer committed serious errors in professional practice? If relevant, see the definitions in national law, the relevant notice or procurement documents. Early termination, damages or other comparable sanctions: Has the tenderer committed significant breaches of contract in connection with the fulfilment of a previous public contract, a previous contract with a public contracting authority or a previous concession contract, where the breach has led to the cancellation of the contract, compensation or other similar sanctions? Payment of social security contributions: Have tenderers failed to fulfil all their social security obligations in the country where they are established and in their member state, if this is a different country than what he is established in? Business activities are suspended: Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions. Payment of taxes: Has the tenderer not fulfilled his tax and duty obligations in the country in which he is established, and in the contracting authority's member state, if this is a different country than what he is established in? Terrorist offences or offences linked to terrorist activities: Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body, or has the competence to represent or control or make decisions in such bodies, in the event a legal verdict has been convicted of acts of terrorism or criminal acts connected to terrorist activities by a verdict handed down no more than five years ago, or a rejection period set out directly in the judgement that still applies? Acts of terrorism or criminal acts relating to terrorist activity as defined in Article 1 and 3 of the Council ́s framework decision 2002/475/RIA of 13 June 2002 on combating terrorism (EFT L 164, af 22.6.2002, p. 3). This rejection reason also includes incitement to, participation or attempts to commit such actions as included in Article 4 in the mentioned framework decision. 5. Lot 5.1. Lot: LOT-0000 Title: 2599a HAE disease Description: The contracting authority for this competition is Sykehusinnkjøp HF, on behalf of the four regional health authorities in Norway: Helse Sør-Øst RHF, Helse Vest RHF, Helse Midt-Norway RHF and Helse Nord RHF. Internal identifier: 2024/353 5.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33600000 Pharmaceutical products 5.1.2. Place of performance Country: Norway Anywhere in the given country 5.1.3. Estimated duration Start date: 31/01/2025 Duration end date: 31/01/2026 5.1.5. Value Estimated value excluding VAT: 375 000 000,00 NOK 5.1.6. General information Reserved participation: Participation is not reserved. Procurement Project not financed with EU Funds. The procurement is covered by the Government Procurement Agreement (GPA): yes Information about previous notices: Identifier of the previous notice: 579523-2024 5.1.9. Selection criteria Criterion: Type: Economic and financial standing Name: 'Total' annual turnover Description: The tenderer ́s ("total") annual turnover for the number of financial years requested in the tender notice or in the procurement documents is as follows: Use of this criterion: Not used Criterion: Type: Economic and financial standing Name: Average annual turnover Description: The tenderer ́s average annual turnover for the number of years requested in the notice or in the procurement documents is as follows: Use of this criterion: Not used Criterion: Type: Economic and financial standing Name: "Specific annual turnover" Description: Are the tenderer's ("specific") annual turnover within the area that the contract applies to and specified in the notice or in the procurement documents for the number of accounting years requested is as follows: Use of this criterion: Not used Criterion: Type: Economic and financial standing Name: Average set-up Description: Is the tenderer's average annual turnover within the area requested by the contract and specified in the notice or in the procurement documents for the number of financial years requested: Use of this criterion: Not used Criterion: Type: Economic and financial standing Name: The tenderer's establishment date Description: If the information about the turnover (combined or specific) is not available for the entire requested period, please state the date the company was established, or the tenderers started their business: Use of this criterion: Not used Criterion: Type: Economic and financial standing Name: Financial key figures Description: For financial key figures stated in the notice or in the procurement documents, the tenderer declares that the actual value(s) of the requested key figures are as follows: Use of this criterion: Not used Criterion: Type: Economic and financial standing Name: Liability insurance Description: The insured amount in the tenderer ́s liability insurance is the following: Use of this criterion: Not used Criterion: Type: Economic and financial standing Name: Other economic and financial requirements Description: Regarding any other economic and financial requirements that have been stated in the notice or in the procurement documents, the tenderer declares that: Use of this criterion: Not used Criterion: Type: Other Name: Certificates issued by independent bodies for quality assurance standards. Description: Can tenderers submit certificates issued by independent bodies that document that the tenderer fulfils the stated quality assurance standards, including universal design requirements? Use of this criterion: Not used Criterion: Type: Other Name: Certificates issued by independent bodies for environmental management standards. Description: Is the tenderer able to submit certificates issued by independent bodies as documentation that the tenderer fulfils the stated environmental management systems or standards? Use of this criterion: Not used Criterion: Type: Suitability to pursue the professional activity Name: Registered in a trade register Description: Tenderers are registered in a professional register in the member state in which the tenderer is established. As described in annex XI of directive 2014/24/EU; suppliers from certain member states may have to fulfil other requirements in the mentioned annex. Use of this criterion: Not used Criterion: Type: Suitability to pursue the professional activity Name: Registered in a trade register or company register. Description: Tenderers are registered in a company register or a trade register in the member state in which the tenderer is established. As described in annex XI of directive 2014/24/EU; suppliers from certain member states may have to fulfil other requirements in the mentioned annex. Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Only for public goods deliveries Description: Only for public goods deliveries: In the reference period, the tenderer has carried out the following important deliveries of the requested type, or the following important services of the requested type. The contracting authority can require up to three years experience and allow experience from the previous three years to be taken into consideration. Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Technical personnel or technical units Description: Tenderers can use the following technical personnel or technical units , particularly those who are responsible for quality control: For technical personnel or technical units that do not directly belong to the tenderer ́s business, but if the capacity the tenderer will use, cf. part II, section C, separate ESPD forms shall be supplemented. Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Technical facilities and quality assurance measures Description: The tenderer utilises the following technical facilities and quality assurance measures and the tenderer ́s survey and research facility is as follows: Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Investigation and research facilities Description: The tenderer ́s survey and research facilitates are as follows: Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Management and tracing of the supply chain Description: The tenderer will be able to use the following management of the supply chain and tracing systems for the execution of the contract: Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Control Permission Description: For goods or services that are complicated, or that in exceptional cases shall be used for a particular purpose: Will the tenderer allow checks of the tenderer's production capacity or technical capacity and, where necessary, of the survey and research facilities that the tenderer has at its disposal and of quality control measures? The inspections shall be undertaken by the contracting authority or the contracting authority can leave it to a competent public body in the country where the tenderer is established. Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Education and professional qualifications Description: The following education and professional qualifications are possessed by the tenderer and/or (depending on the requirements set in the notice or in the procurement documents) of the leading employees: Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Environmental management measures Description: Tenderers can employ the following environmental management measures in connection with the execution of the contract: Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Number of employees in the management Description: The tenderer ́s number of employees in the management during the last three years was as follows: Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Average workforce Description: The tenderer's average annual workforce in the last three years has been as follows: Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Tools, materials and technical equipment. Description: Tenderers can use the following tools, material and technical equipment to carry out the contract: Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Portion of the contract to sub-suppliers. Description: The tenderer is considering to outsource the following part (as a percentage) of the contract to sub-suppliers. Note that if the tenderer has decided to outsource a part of the contract to sub-suppliers and will use the sub-suppliers ́ capacity to carry out this part, a special ESPD will be supplemented for such sub-suppliers, see part II, section C, above. Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Procurement of goods: Requested samples, descriptions or photographs that do not need to be accompanied by certificates that they are genuine. Description: Procurement of goods: The tenderer presents supplies that shall be delivered, requested samples, descriptions or photographs, which do not need to be accompanied by certificates that they are genuine. Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Procurement of goods: Requested samples, descriptions or photographs with certificates. Description: When procurement of goods: If requested, the tenderer further declares that they will deliver the requested certificates that they are genuine. Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: When procuring goods: Certificates issued by official bodies for quality control Description: Can tenderers submit the requested certificates issued by official bodies for quality control, and who can confirm that the goods, which are clearly identified by reference to technical specifications or standards, as determined in the notice or in the procurement documents, are in accordance with these? Use of this criterion: Not used Criterion: Type: Technical and professional ability Name: Tenderers shall have a valid wholesaler licence or production licence in the EU/EEA. Description: Each tenderer must document that it holds a valid wholesaler licence or manufacturer licence for its own preparations in the EU/EEA area at the time of the tender offer. If the tenderer does not have a wholesaler or production licence itself, but e.g. acts on behalf of the group/parent company or has an agency, the commitment statement and ESPD form from the holder of the wholesaler/production permission for the offered products shall be enclosed. Minimum qualification requirements Use of this criterion: Used 5.1.10. Award criteria Criterion: Type: Price Name: Price Weight (percentage, exact): 100 5.1.11. Procurement documents Languages in which the procurement documents are officially available: Norwegian Deadline for requesting additional information: 20/11/2024 11:00:00 (UTC) Address of the procurement documents: https://permalink.mercell.com/240845840.aspx 5.1.12. Terms of procurement Terms of submission: Electronic submission: Required Address for submission: https://permalink.mercell.com/240845840.aspx Languages in which tenders or requests to participate may be submitted: Danish, Norwegian, Swedish Electronic catalogue: Not allowed Advanced or qualified electronic signature or seal (as defined in Regulation (EU) No 910/2014) is required Variants: Not allowed Deadline for receipt of tenders: 02/12/2024 11:00:00 (UTC) Deadline until which the tender must remain valid: 6 Months Information about public opening: Opening date: 02/12/2024 11:00:00 (UTC) 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: yes Electronic payment will be used: yes 5.1.15. Techniques Framework agreement: Framework agreement, partly without reopening and partly with reopening of competition Information about the dynamic purchasing system: No dynamic purchase system 5.1.16. Further information, mediation and review Review organisation: Indre og Østre Finnmark tingrett, rettssted Vadsø 8. Organisations 8.1. ORG-0001 Official name: SYKEHUSINNKJØP HF Registration number: 916879067 Postal address: Postboks 40 Town: VADSØ Postcode: 9811 Country subdivision (NUTS): Troms og Finnmark (NO074) Country: Norway Contact point: Postmottak Sykehusinnkjøp Email: post@sykehusinnkjop.no Telephone: +47 78950700 Internet address: http://www.sykehusinnkjop.no Roles of this organisation: Buyer Central purchasing body acquiring supplies and/or services intended for other buyers 8.1. ORG-0002 Official name: Indre og Østre Finnmark tingrett, rettssted Vadsø Registration number: 926722840 Town: Vadsø Country: Norway Email: indre.og.ostre.finnmark.tingrett@domstol.no Telephone: +4778011700 Roles of this organisation: Review organisation 11. Notice information 11.1. Notice information Notice identifier/version: 04b5c129-ac91-4434-8492-f694d9acfbcd - 01 Form type: Competition Notice type: Contract or concession notice – standard regime Notice subtype: 16 Notice dispatch date: 28/10/2024 13:38:54 (UTC) Notice dispatch date (eSender): 28/10/2024 13:39:12 (UTC) Languages in which this notice is officially available: English 11.2. Publication information Notice publication number: 657018-2024 OJ S issue number: 211/2024 Publication date: 29/10/2024 Czech document download: https://ted.europa.eu/cs/notice/657018-2024/pdf Danish document download: https://ted.europa.eu/da/notice/657018-2024/pdf German document download: https://ted.europa.eu/de/notice/657018-2024/pdf Greek document download: https://ted.europa.eu/el/notice/657018-2024/pdf Spanish document download: https://ted.europa.eu/es/notice/657018-2024/pdf English document download: https://ted.europa.eu/en/notice/657018-2024/pdf Estonian document download: https://ted.europa.eu/et/notice/657018-2024/pdf Finnish document download: https://ted.europa.eu/fi/notice/657018-2024/pdf French document download: https://ted.europa.eu/fr/notice/657018-2024/pdf Irish document download: https://ted.europa.eu/ga/notice/657018-2024/pdf Croatian document download: https://ted.europa.eu/hr/notice/657018-2024/pdf Hungarian document download: https://ted.europa.eu/hu/notice/657018-2024/pdf Italian document download: https://ted.europa.eu/it/notice/657018-2024/pdf Lithuanian document download: https://ted.europa.eu/lt/notice/657018-2024/pdf Latvian document download: https://ted.europa.eu/lv/notice/657018-2024/pdf Maltese document download: https://ted.europa.eu/mt/notice/657018-2024/pdf Dutch document download: https://ted.europa.eu/nl/notice/657018-2024/pdf Polska document download: https://ted.europa.eu/pl/notice/657018-2024/pdf Portuguese document download: https://ted.europa.eu/pt/notice/657018-2024/pdf Romanian document download: https://ted.europa.eu/ro/notice/657018-2024/pdf Slovak document download: https://ted.europa.eu/sk/notice/657018-2024/pdf Slovenian document download: https://ted.europa.eu/sl/notice/657018-2024/pdf Swedish document download: https://ted.europa.eu/sv/notice/657018-2024/pdf Bulgarian document download: https://ted.europa.eu/bg/notice/657018-2024/pdf