Danish law

Joint Nordic Procurement of Pharmaceuticals - 2024 - NF2.200.a

Denmark, Norway and Iceland have entered into cooperation regarding the procurement of pharmaceuticals. The countries will jointly procure and award framework agreements in order to ensure the supply of pharmaceuticals in the countries. In Denmark certain pharmaceuticals are resold to the Faroe Island and Greenland. Under this procurement group, the pharmaceuticals are tendered under each procurement no. for the purpose of supplying the Contracting Authorities as 2 markets (Norway as 1 market and Denmark and Iceland as 1 market) see section II.2.4 and the tender specification.

The obligation to deliver the pharmaceuticals in Iceland is subject to the precondition that the supplier obtains an exemption regarding printed labels and leaflets. If the supplier does not obtain such exemption the agreement will only apply to Denmark and Norway, see the Framework agreement section 2.2.1 and Appendix 6.

1

ATC Code: A04AA01

Generic Name: Ondansetrone

Pharmaceutical form: Injection Fluid

Strenght: 2 mg/ml

Package: 2 ml

Unit: 16 mg

Volume in units: (Denmark 112.158) (Iceland 7.500)

ATC Code: A04AA01

Generic Name: Ondansetrone

Pharmaceutical form: Injection Fluid

Strenght: 2 mg/ml

Package: 4 ml

Unit: 16 mg

Volume in units: (Denmark 8.562) (Iceland 12.500)

Each procurement number is a separate lot for the pharmaceutical indicated and is put up for tender independently of the other procurement numbers. This means that a tenderer may submit a tender for one, several or all procurement numbers (lots), and that framework agreements will be awarded separately for each procurement number. However, the aim is to conclude framework agreements with different suppliers for the procurement numbers 1 and 2, which are linked procurement numbers.

If there is only one compliant tender for either procurement numbers 1 or 2, the framework agreement for the procurement number in question is awarded to the supplier concerned. The supplier concerned will then be excluded from award on the other of the two procurement numbers, and the framework agreement will be awarded to the supplier of the remaining suppliers offering the “best price-quality ra-tio”.

If there are several compliant tenders for both procurement numbers 1 and 2, the award under pro-curement number 1 will take precedence. This means that if the same supplier has submitted a tender offering the “best price-quality ratio” for both procurement numbers 1 and 2, and there are several com-pliant tenders for both procurement numbers 1 and 2, the Contracting Authorities will only award the supplier concerned a framework agreement for procurement number 1, since the framework agreement for procurement number 2 is awarded to the supplier with the “second best price-quality ratio” under the procurement number concerned.

If there is only one compliant tender for both procurement numbers 1 and 2, the framework agreements will be awarded to the suppliers of the respective compliant tenders, notwithstanding that this may mean that the same supplier will be awarded a framework agreement for both procurement numbers 1 and 2.

Under the title "quantity in units", an estimated consumption of the pharmaceuticals is indicated for each of the countries. It should be noted that this estimate corresponds to the historical consumption of the pharmaceuticals put up for tender and that suppliers must expect that the actual purchase under a framework agreement may deviate significantly from the estimate. Reference is made to paragraph 5.6 of the tender specifications and clause 4.2 in the framework agreement.

The Supplier must have authorisation to produce, import or receive pharmaceuticals for wholesale distribution within the EU/EEA.

The Pharmaceuticals shall be included in the Danish Medicines Agency’s list of medicine prices (“medicinpriser.dk”), the Norwegian "Farmalogg" and the Icelandic “Lyfjaverðskrá” not later than 5 February 2024 in order to ensure supply from the beginning of the Purchase Period.

The framework agreements are non-exclusive to the supplier. The hospitals and health authorities are not obliged to use the framework agreement.

The Contracting Authorities shall be entitled to extend the framework agreement up to one time for each pharmaceutical on unchanged terms and conditions by up to 12 months.

Clause 8.2 of the framework agreement provides for an option for delivery in a pre-agreement period (i.e. before the purchase period begins) and an option for delivery in a post-agreement period (i.e. after the purchase period). The two options may be exercised on the terms and conditions stipulated in the framework agreement.

2

ATC Code: A04AA01

Generic Name: Ondansetrone

Pharmaceutical form: Injection Fluid

Strenght: 2 mg/ml

Package: 2 ml

Unit: 16 mg

Volume in units: Norway 75.000

ATC Code: A04AA01

Generic Name: Ondansetrone

Pharmaceutical form: Injection Fluid

Strenght: 2 mg/ml

Package: 4 ml

Unit: 16 mg

Volume in units: Norway 8.250

Each procurement number is a separate lot for the pharmaceutical indicated and is put up for tender independently of the other procurement numbers. This means that a tenderer may submit a tender for one, several or all procurement numbers (lots), and that framework agreements will be awarded separately for each procurement number. However, the aim is to conclude framework agreements with different suppliers for the procurement numbers 1 and 2, which are linked procurement numbers.

If there is only one compliant tender for either procurement numbers 1 or 2, the framework agreement for the procurement number in question is awarded to the supplier concerned. The supplier concerned will then be excluded from award on the other of the two procurement numbers, and the framework agreement will be awarded to the supplier of the remaining suppliers offering the “best price-quality ra-tio”.

If there are several compliant tenders for both procurement numbers 1 and 2, the award under pro-curement number 1 will take precedence. This means that if the same supplier has submitted a tender offering the “best price-quality ratio” for both procurement numbers 1 and 2, and there are several com-pliant tenders for both procurement numbers 1 and 2, the Contracting Authorities will only award the supplier concerned a framework agreement for procurement number 1, since the framework agreement for procurement number 2 is awarded to the supplier with the “second best price-quality ratio” under the procurement number concerned.

If there is only one compliant tender for both procurement numbers 1 and 2, the framework agreements will be awarded to the suppliers of the respective compliant tenders, notwithstanding that this may mean that the same supplier will be awarded a framework agreement for both procurement numbers 1 and 2.

Under the title "quantity in units", an estimated consumption of the pharmaceuticals is indicated for each of the countries. It should be noted that this estimate corresponds to the historical consumption of the pharmaceuticals put up for tender and that suppliers must expect that the actual purchase under a framework agreement may deviate significantly from the estimate. Reference is made to paragraph 5.6 of the tender specifications and clause 4.2 in the framework agreement.

The Supplier must have authorisation to produce, import or receive pharmaceuticals for wholesale distribution within the EU/EEA.

The Pharmaceuticals shall be included in the Danish Medicines Agency’s list of medicine prices (“medicinpriser.dk”), the Norwegian "Farmalogg" and the Icelandic “Lyfjaverðskrá” not later than 5 February 2024 in order to ensure supply from the beginning of the Purchase Period.

The framework agreements are non-exclusive to the supplier. The hospitals and health authorities are not obliged to use the framework agreement.

The Contracting Authorities shall be entitled to extend the framework agreement up to one time for each pharmaceutical on unchanged terms and conditions by up to 12 months.

Clause 8.2 of the framework agreement provides for an option for delivery in a pre-agreement period (i.e. before the purchase period begins) and an option for delivery in a post-agreement period (i.e. after the purchase period). The two options may be exercised on the terms and conditions stipulated in the framework agreement.

3

ATC Code: A04AA01

Generic Name: Ondansetrone Ready to use

Pharmaceutical form: Injection Fluid

Strenght: 0,08 mg/ml

Package: 50 ml

Unit: 16 mg

Volume in units: (Denmark 999), (Iceland 999), (Norway 999)

ATC Code: A04AA01

Generic Name: Ondansetrone ready to use

Pharmaceutical form: Injection Fluid

Strenght: 0,08 mg/ml

Package: 100 ml

Unit: 16 mg

Volume in units: (Denmark 999), (Iceland 999), (Norway 999)

Each procurement number is a separate lot for the pharmaceutical indicated and is put up for tender independently of the other procurement numbers. This means that a tenderer may submit a tender for one, several or all procurement numbers (lots), and that framework agreements will be awarded separately for each procurement number. A framework agreement awarded under Procurement number 3 will cover delivery of the pharmaceuticals in all three countries: Denmark, Norway and Iceland.

Under the title "quantity in units", an estimated consumption of the pharmaceuticals is indicated for each of the countries. It should be noted that this estimate corresponds to the historical consumption of the pharmaceuticals put up for tender and that suppliers must expect that the actual purchase under a framework agreement may deviate significantly from the estimate. Reference is made to paragraph 5.6 of the tender specifications and clause 4.2 in the framework agreement.

The Supplier must have authorisation to produce, import or receive pharmaceuticals for wholesale distribution within the EU/EEA.

The Pharmaceuticals shall be included in the Danish Medicines Agency’s list of medicine prices (“medicinpriser.dk”), the Norwegian "Farmalogg" and the Icelandic “Lyfjaverðskrá” not later than 5 February 2024 in order to ensure supply from the beginning of the Purchase Period.

The framework agreements are non-exclusive to the supplier. The hospitals and health authorities are not obliged to use the framework agreement.

The Contracting Authorities shall be entitled to extend the framework agreement up to one time for each pharmaceutical on unchanged terms and conditions by up to 12 months.

Clause 8.2 of the framework agreement provides for an option for delivery in a pre-agreement period (i.e. before the purchase period begins) and an option for delivery in a post-agreement period (i.e. after the purchase period). The two options may be exercised on the terms and conditions stipulated in the framework agreement.

4

ATC Code: J01CE01

Generic Name: Benzylpenicillin

Pharmaceutical form: Injection and infusion Fluid

Strenght: 0,6 g

Package: vial

Unit: 3,6 g

Volume in units: (Denmark 19.864), (Iceland 280)

ATC Code: J01CE01

Generic Name: Benzylpenicillin

Pharmaceutical form: Injection and infusion Fluid

Strenght: 1,2 g

Package: vial

Unit: 3,6 g

Volume in units: (Denmark 93.721), (Iceland 2.083)

ATC Code: J01CE01

Generic Name: Benzylpenicillin

Pharmaceutical form: Injection and infusion Fluid

Strenght: 3 g

Package: vial

Unit: 3,6 g

Volume in units: (Denmark 55.489), (Iceland 4.583)

Each procurement number is a separate lot for the pharmaceutical indicated and is put up for tender independently of the other procurement numbers. This means that a tenderer may submit a tender for one, several or all procurement numbers (lots), and that framework agreements will be awarded separately for each procurement number. However, the aim is to conclude framework agreements with different suppliers for the procurement numbers 4 and 5, which are linked procurement numbers.

If there is only one compliant tender for either procurement numbers 4 or 5, the framework agreement for the procurement number in question is awarded to the supplier concerned. The supplier concerned will then be excluded from award on the other of the two procurement numbers, and the framework agreement will be awarded to the supplier of the remaining suppliers offering the “best price-quality ra-tio”.

If there are several compliant tenders for both procurement numbers 4 and 5, the award under pro-curement number 1 will take precedence. This means that if the same supplier has submitted a tender offering the “best price-quality ratio” for both procurement numbers 4 and 5, and there are several com-pliant tenders for both procurement numbers 4 and 5, the Contracting Authorities will only award the supplier concerned a framework agreement for procurement number 4, since the framework agreement for procurement number 5 is awarded to the supplier with the “second best price-quality ratio” under the procurement number concerned.

If there is only one compliant tender for both procurement numbers 4 and 5, the framework agreements will be awarded to the suppliers of the respective compliant tenders, notwithstanding that this may mean that the same supplier will be awarded a framework agreement for both procurement numbers 4 and 5.

Under the title "quantity in units", an estimated consumption of the pharmaceuticals is indicated for each of the countries. It should be noted that this estimate corresponds to the historical consumption of the pharmaceuticals put up for tender and that suppliers must expect that the actual purchase under a framework agreement may deviate significantly from the estimate. Reference is made to paragraph 5.6 of the tender specifications and clause 4.2 in the framework agreement.

The Supplier must have authorisation to produce, import or receive pharmaceuticals for wholesale distribution within the EU/EEA.

The Pharmaceuticals shall be included in the Danish Medicines Agency’s list of medicine prices (“medicinpriser.dk”), the Norwegian "Farmalogg" and the Icelandic “Lyfjaverðskrá” not later than 5 February 2024 in order to ensure supply from the beginning of the Purchase Period.

The framework agreements are non-exclusive to the supplier. The hospitals and health authorities are not obliged to use the framework agreement.

The Contracting Authorities shall be entitled to extend the framework agreement up to one time for each pharmaceutical on unchanged terms and conditions by up to 12 months.

Clause 8.2 of the framework agreement provides for an option for delivery in a pre-agreement period (i.e. before the purchase period begins) and an option for delivery in a post-agreement period (i.e. after the purchase period). The two options may be exercised on the terms and conditions stipulated in the framework agreement.

5

ATC Code: J01CE01

Generic Name: Benzylpenicillin

Pharmaceutical form: Injection and infusion Fluid

Strenght: 0,6 g

Package: vial

Unit: 3,6 g

Volume in units: (Norway 2.167)

ATC Code: J01CE01

Generic Name: Benzylpenicillin

Pharmaceutical form: Injection and infusion Fluid

Strenght: 1,2 g

Package: vial

Unit: 3,6 g

Volume in units: (Norway 153.333)

ATC Code: J01CE01

Generic Name: Benzylpenicillin

Pharmaceutical form: Injection and infusion Fluid

Strenght: 3 g

Package: vial

Unit: 3,6 g

Volume in units: (Norway 187.500)

Each procurement number is a separate lot for the pharmaceutical indicated and is put up for tender independently of the other procurement numbers. This means that a tenderer may submit a tender for one, several or all procurement numbers (lots), and that framework agreements will be awarded separately for each procurement number. However, the aim is to conclude framework agreements with different suppliers for the procurement numbers 4 and 5, which are linked procurement numbers.

If there is only one compliant tender for either procurement numbers 4 or 5, the framework agreement for the procurement number in question is awarded to the supplier concerned. The supplier concerned will then be excluded from award on the other of the two procurement numbers, and the framework agreement will be awarded to the supplier of the remaining suppliers offering the “best price-quality ra-tio”.

If there are several compliant tenders for both procurement numbers 4 and 5, the award under pro-curement number 1 will take precedence. This means that if the same supplier has submitted a tender offering the “best price-quality ratio” for both procurement numbers 4 and 5, and there are several com-pliant tenders for both procurement numbers 4 and 5, the Contracting Authorities will only award the supplier concerned a framework agreement for procurement number 4, since the framework agreement for procurement number 5 is awarded to the supplier with the “second best price-quality ratio” under the procurement number concerned.

If there is only one compliant tender for both procurement numbers 4 and 5, the framework agreements will be awarded to the suppliers of the respective compliant tenders, notwithstanding that this may mean that the same supplier will be awarded a framework agreement for both procurement numbers 4 and 5.

Under the title "quantity in units", an estimated consumption of the pharmaceuticals is indicated for each of the countries. It should be noted that this estimate corresponds to the historical consumption of the pharmaceuticals put up for tender and that suppliers must expect that the actual purchase under a framework agreement may deviate significantly from the estimate. Reference is made to paragraph 5.6 of the tender specifications and clause 4.2 in the framework agreement.

The Supplier must have authorisation to produce, import or receive pharmaceuticals for wholesale distribution within the EU/EEA.

The Pharmaceuticals shall be included in the Danish Medicines Agency’s list of medicine prices (“medicinpriser.dk”), the Norwegian "Farmalogg" and the Icelandic “Lyfjaverðskrá” not later than 5 February 2024 in order to ensure supply from the beginning of the Purchase Period.

The framework agreements are non-exclusive to the supplier. The hospitals and health authorities are not obliged to use the framework agreement.

The Contracting Authorities shall be entitled to extend the framework agreement up to one time for each pharmaceutical on unchanged terms and conditions by up to 12 months.

Clause 8.2 of the framework agreement provides for an option for delivery in a pre-agreement period (i.e. before the purchase period begins) and an option for delivery in a post-agreement period (i.e. after the purchase period). The two options may be exercised on the terms and conditions stipulated in the framework agreement.

When submitting a tender, suppliers must use the European Single Procurement Document (ESPD) in the tendering system for the declaration regarding the compulsory grounds for exclusion set out in sections 135-136 of the Danish Public Procurement Act (udbudsloven) (the Act can be found at www.retsinformation.dk). Further information on the completion and application of the ESPD in the tender process is available in the guide drawn up by Amgros in this respect and in the "Instructions for the European Single Procurement Document" drawn up by the Danish Competition and Consumer Authority (Konkurrence- og Forbrugerstyrelsen). The successful tenderer(s) to whom the Contracting Authorities intend to award the framework agreement must also, before the award, provide documentation to the Contracting Authorities regarding the absence of compulsory groundsfor exclusion as set out in sections 152-153 of the Public Procurement Act. The Contracting Authorities are not entitled to exclude a supplier who is subject to one or more of the mandatory exclusion grounds set out insections 135-136 of the Public Procurement Act if the supplier has provided sufficient documentation that the supplier is reliable, even if the supplier is subject to one or more of the grounds for exclusion set out in section138 of the Public Procurement Act. The Contracting Authorities reserve the right to carry out a so-called "self-cleaning" process if relevant.

Reference is made to the provisions of the draft framework agreement and section II.2.4.

No specific legal form is required. If the contract is awarded to a group of suppliers, each participant must undertake joint and several liability and appoint a joint representative.

Amgros I/S, Dampfærgevej 27-29, DK-2100 Copenhagen Ø

The Tenderers are not permitted to attend the opening of the tenders. Tenders will be registered upon receipt, and tenders received on time will be opened collectively after expiry of the deadline for submission of tenders. With the notice regarding the tender evaluation, the tenderers will receive a comprehensive overview of the operators that have submitted compliant tenders.

This call for tenders is conducted as an open procedure in accordance with the Danish Procurement Act (udbudsloven). The procurement procedure is subject to Danish law and any complaints of the procurement procedure shall be lodged with the Danish Complaints Board for Public Procurement (Klagenævnet for udbud),see section VI.4.3.

In relation to section II.2.4, it should be noted, that the Contracting Authorities have considered wheth-er the procurement group could be further subdivided. The Contracting Authorities have deemed that this is not the case based on the considerations of economies of scale, which will not be realizable with a further subdivision as well as costs and patient safety considerations related to the subsequent man-agement of contract- and pharmaceuticals.

In relation to sections II.1.5 and II.2.6 it should be noted that the estimated value indicated in section II.1.5 is the total estimated value of all procurement numbers (lots) for the duration of the framework agreement, including the option of renewal, see section II.2.7. Section II.2.6 sets out the estimated value for each procurement number, including the option of renewal, see section II.2.7. The value is based on the AIP ("Apotekernes Indkøbspris" published by the Danish Medicines Agency) of the pharmaceuticals. It should furthermore be noted that the estimated value is based on historic consumption data and that the actual purchase under a framework agreement may deviate significantly from the estimate, see section II.2.4, paragraph 5.6 of the tender specifications and clause 4.2 of the framework agreement.

Questions concerning the tender documents must be submitted through the tendering system, see the provisions of the tender specifications in this regard.

The access to submit tender requires that the operator is registered as a user of Amgros' tendering system. The registration as a user may take a few days, and the tenderer must therefore make sure to register in good time. Reference is made to the information provided in the tendering system, including the user guide.

In relation to section VI.2 it should be noted that electronic invoicing is required.

Pursuant to the Danish Act on the Complaints Board for Public Procurement (Act no. 593 of 2 June 2016 as amended) the following deadlines apply to the lodging of complaints:

Complaints of the tendering procedure must be lodged with the Complaints Board for Public Procurement within 6 months after the contracting entity has entered into a framework agreement calculated from the day after the day when the contracting entity has notified the affected applicants and tenderers, see section 7(2), para.(3) of the Act. Not later than at the time of lodging a complaint with the Danish Complaints Board for Public Procurement, the complainant must notify the contracting authorities in writing that a complaint has been lodged with the Danish Complaints Board for Public Procurement and whether the complaint was lodged during the standstill period, see section 6(4) of the Act. In cases where the complaint was not lodged within the standstill period, the complainant must furthermore indicate whether a suspensory effect of the complaint has been requested, see clause 6(4) of the Act.