Monitoring of the medicines Adalimumab and Infliximab, tests for concentration in serum to St. Olav Hospital H

The Department of Immunology and Transfusion Medicine at St.Olavs Hospital uses the above mentioned tests to measure the concentration of the medicines in human serum in patients with autoimmune encephalosis diseases (such as arthritis, Crohn's disease, ulcerative colitis, colorus and multiple sclerosis (MS)). The analyses are part of the disease …

CPV: 33690000 Medicamentos diversos, 33696500 Reactivos de laboratorio
Plazo:
30 de enero de 2025 a las 11:00
Tipo de plazo:
Presentación de una oferta
Lugar de ejecución:
Monitoring of the medicines Adalimumab and Infliximab, tests for concentration in serum to St. Olav Hospital H
Organismo adjudicador:
SYKEHUSINNKJØP HF
Número de premio:
2024/728

1. Buyer

1.1 Buyer

Official name : SYKEHUSINNKJØP HF
Legal type of the buyer : Body governed by public law
Activity of the contracting authority : Health

1.1 Buyer

Official name : St. Olav Hospital HF
Legal type of the buyer : Body governed by public law
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : Monitoring of the medicines Adalimumab and Infliximab, tests for concentration in serum to St. Olav Hospital H
Description : The Department of Immunology and Transfusion Medicine at St.Olavs Hospital uses the above mentioned tests to measure the concentration of the medicines in human serum in patients with autoimmune encephalosis diseases (such as arthritis, Crohn's disease, ulcerative colitis, colorus and multiple sclerosis (MS)). The analyses are part of the disease follow-up, where a monitors medicine concentration.
Procedure identifier : 0efaf6b9-0743-425f-89d1-5507b55c0d9b
Previous notice : 741803-2024
Internal identifier : 2024/728
Type of procedure : Open
The procedure is accelerated : no
Justification for the accelerated procedure :
Main features of the procedure : The Department of Immunology and Transfusion Medicine at St.Olavs Hospital uses the above mentioned tests to measure the concentration of the medicines in human serum in patients with autoimmune encephalosis diseases (such as arthritis, Crohn's disease, ulcerative colitis, colorus and multiple sclerosis (MS)). The analyses are a part of following-up the disease, where one monitors the drug concentration. The total estimated volume for analyses is based on analysis results for 2023 and the first half of 2024 at the immunological section:- Infliximab: Approx. 3,000 infliximab concentration measurements.- Adalimumab: Ca. 2000 adalimumab concentration measurements. The number of analyses will depend on the results of the national LIS tender for the relevant medicines. Sykehusinnkjøp HF, division pharmaceuticals is responsible for the procurement of medicines for the country's hospital. The medicines Adalimumab and Infliximab are included in the procurement TNF BIO. Expected NOK 100,000 NOK 500,000 excluding VAT per annumIt given consumption/extent is an estimate of information for the tenderer and is not binding for future contract volume.

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33696500 Laboratory reagents
Additional classification ( cpv ): 33690000 Various medicinal products

2.1.2 Place of performance

Country subdivision (NUTS) : Trøndelag ( NO060 )
Country : Norway

2.1.3 Value

Estimated value excluding VAT : 2 000 000 Norwegian krone

2.1.4 General information

Legal basis :
Directive 2014/24/EU
Anskaffelsesforskriften -
Anskaffelsesforskriften -
Anskaffelsesforskriften -
Anskaffelsesforskriften -
Anskaffelsesforskriften -

2.1.6 Grounds for exclusion

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.
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)
Breaching of obligations in the fields of environmental law : Is the tenderer aware of breaches of environmental provisions as stated in national law, the relevant notice or procurement documents or Article 18 (2) of Directive 2014/24/EU.
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.
Breaching of obligations in the fields of labour law : Is the tenderer aware of breaches of provisions on working conditions as stated in national law, the relevant notice or procurement documents or Article 18 (2) of Directive 2014/24/EU.
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?
Breaching of obligations in the fields of social law : Is the tenderer aware of breaches of provisions on social conditions as stated in national law, the relevant notice or procurement documents or Article 18 (2) of Directive 2014/24/EU.
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?
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 technical ID : LOT-0000

Title : Monitoring of the medicines Adalimumab and Infliximab, tests for concentration in serum to St. Olav Hospital H
Description : The Department of Immunology and Transfusion Medicine at St.Olavs Hospital uses the above mentioned tests to measure the concentration of the medicines in human serum in patients with autoimmune encephalosis diseases (such as arthritis, Crohn's disease, ulcerative colitis, colorus and multiple sclerosis (MS)). The analyses are part of the disease follow-up, where a monitors medicine concentration.
Internal identifier : 2024/728

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33696500 Laboratory reagents
Additional classification ( cpv ): 33690000 Various medicinal products

5.1.2 Place of performance

Country subdivision (NUTS) : Trøndelag ( NO060 )
Country : Norway
Additional information :

5.1.3 Estimated duration

Duration : 120 Month

5.1.5 Value

Estimated value excluding VAT : 2 000 000 Norwegian krone

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

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 : Economic and financial standing
Name : Other economic and financial requirements
Description : Tenderers shall have sufficient economic and financial solidity to fulfil the contractual obligations. The credit worthiness that will form the basis for qualification for this competition will not be lower than "Credit worthy" (equivalent to A at Bisnode CreditPro,DB). The Contracting Authority will evaluate the Tenderer's fulfilment of the qualification requirements in the following manner: In their evaluation, the contracting authority will use Bisnode CreditPro, DB or other equivalent credit information agency in their evaluation. The contracting authority will obtain a credit rating as a basis for the assessment stated above. • The collection will occur after the tender deadline and on the same date for all tenderers. • Companies with a lower rating, newly established companies, companies under foundation, companies without activity or companies that are not credit appraisaled, can instead submit parent company guarantees, bank guarantees, or similar that provide an equivalent security for the ability to fulfil the contract. The organisation number for the parent company shall be provided when using a parent company guarantee. If a tenderer has a justifiable reason for not submitting the documentation that the Contracting Authority has demanded, tenderers can prove their economic and financial capacity by any other document, including, for example, by a parent company guarantee, bank guarantee, etc. Documentation is to be submitted with the tender if the tenderer needs to prove his financial capacity in a way. Minimum qualification requirements
Use of this criterion : 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 : Other
Name : Certificates issued by independent bodies for quality assurance standards.
Description : Tenderers are asked to submit certificates issued by independent bodies as documentation that the tenderer fulfils the stated quality assurance standards. Description of the requirement/documentation: Tenderers shall have a well-functioning quality assurance/management system. Tenderers shall give an account of this. In accordance with the Contracting Authority's ISO 9001 or equivalent third party verified systems, it is sufficient to present a valid certificate. Minimum qualification requirements
Use of this criterion : Used
Criterion :
Type : Other
Name : Environment
Description : Competence and systems which ensure that the service can be provided with low environmental impact and a high degree of security are required. This applies to both the transport that will occur and the work to be carried out. Documentation requirement Certification iht. ISO 14001, EMAS or The Eco-Lighthouse Scheme, or other environmental management standards based on relevant European or international standards certified by bodies that comply with community regulations or relevant European or international standards regarding certification. Documentation requirement. If a tenderer does not have such certification, other documentation for equivalent environmental management measures will be accepted. Minimum qualification requirements
Use of this criterion : 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 : 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 : Reference Project
Description : Tenderers shall have sufficient ability and capacity to be able to fulfil the contractual obligations. (The Contracting Authority will assess the Tenderer's experience with delivering the performance included in the competition). Documentation requirement. The Contracting Authority will assess the Tenderer's experience with delivery of the performance the competition comprises in regard to: Tenderers shall state reference laboratories where the offered kits are or have been used, preferably in the Nordic countries or Europe. Stated on request. The references shall be from equivalent hospital environments/clinical laboratories and equivalent use as described. Complete annex 5 Response Form References. Minimum qualification requirements
Use of this criterion : Used

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Norwegian
Deadline for requesting additional information : 22/01/2025 11:00 +00:00
Address of the procurement documents : https://permalink.mercell.com/245079869.aspx

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Norwegian
Electronic catalogue : Required
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 : 30/01/2025 11:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 30/01/2025 11:00 +00:00
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, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Øst-Finnmark tingrett

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
Telephone : +47 78950700
Roles of this organisation :
Buyer
Group leader
Central purchasing body acquiring supplies and/or services intended for other buyers

8.1 ORG-0002

Official name : Øst-Finnmark tingrett
Registration number : 926 722 840
Town : Vadsø
Country : Norway
Telephone : 78 94 11 60
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : St. Olav Hospital HF
Registration number : 883974832
Town : Trondheim
Country : Norway
Telephone : 72 57 30 00
Roles of this organisation :
Buyer

10. Change

Version of the previous notice to be changed : cf146341-71c3-428a-9dc5-43eee3b69469-01

10.1 Change

Section identifier : PROCEDURE

11. Notice information

11.1 Notice information

Notice identifier/version : 517c8b23-473e-4a52-909d-dad32d055632 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 20/12/2024 08:55 +00:00
Notice dispatch date (eSender) : 20/12/2024 09:09 +00:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00791166-2024
OJ S issue number : 249/2024
Publication date : 23/12/2024