Danish Law.

Joint Nordic Procurement of Pharmaceuticals — 2022 — NF2.601.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 to the public hospitals and health authorities in the countries. In Denmark certain pharmaceuticals are resold to the Faroe Island and Greenland.

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.

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

1

ATC Code: J01CA01

Generic name: Ampicilline

Pharmaceutical form: Injection fluid

Strength: 1 g

Unit: 6 g

Volume in units: (Denmark 12.525) (Norway: 12.646) (Iceland: 3.166)

ATC Code: J01CA01

Generic name: Ampicilline

Pharmaceutical form: Injection fluid

Strength: 2 g

Unit: 6 g

Volume in units: (Denmark 47.579) (Norway: 149.333) (Iceland: 10)

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. Reference is made to the tender specifications, including the provision on the list of products in general.

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’) and the Norwegian ‘Farmalogg’ and the Icelandic ‘Lyfjaverðskrá’ not later than 7 February 2022 in order to ensure supply from the beginning of the purchase period.

The contracting authorities shall be entitled to extend the framework agreement up to 2 times 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.

For

2

Procurement no.: 2

ATC Code: J01DC02

Generic name: Cefuroxime

Pharmaceutical form: Duplex infusionbag

Strength: 1500 mg

Unit: 3 g

Volume in units: (Denmark 104.928) (Norway: 12.000) (Iceland: 10)

ATC Code: J01DC02

Generic name: Cefuroxime

Pharmaceutical form: Duplex infusionbag

Strength: 750 mg

Unit: 3 g

Volume in units: (Denmark 31.692) (Norway: 1.200) (Iceland: 10)

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. Reference is made to the tender specifications, including the provision on the list of products in general.

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”) and the Norwegian “Farmalogg” and the Icelandic “Lyfjaverðskrá” not later than 7 February 2022 in order to ensure supply from the beginning of the Purchase Period.

The Contracting Authorities shall be entitled to extend the framework agreement up to 2 times 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.

For

3

Procurement no.: 3

ATC Code: J01DD02

Generic name: Ceftazidime

Strength: 1 g

Unit: 4 g

Volume in units: (Denmark 1.625) (Norway: 4.000) (Iceland: 580)

ATC Code: J01DD02

Generic name: Ceftazidime

Strength: 2 g

Unit: 4 g

Volume in units: (Denmark 7.050) (Norway: 25.000) (Iceland: 2.010)

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. Reference is made to the tender specifications, including the provision on the list of products in general.

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”) and the Norwegian “Farmalogg” and the Icelandic “Lyfjaverðskrá” not later than 7 February 2022 in order to ensure supply from the beginning of the Purchase Period.

The Contracting Authorities shall be entitled to extend the framework agreement up to 2 times 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.

For

4

Procurement no.: 4

ATC Code: J01DD04

Generic name: Ceftriaxone

Strength: 1 g

Unit: 2 g

Volume in units: (Denmark 9.520) (Norway: 4.150) (Iceland: 5.666)

ATC Code: J01DD04

Generic name: Ceftriaxone

Strength: 2 g

Unit: 2 g

Volume in units: (Denmark 56.980) (Norway: 60.200) (Iceland: 4.231)

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. Reference is made to the tender specifications, including the provision on the list of products in general.

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”) and the Norwegian “Farmalogg” and the Icelandic “Lyfjaverðskrá” not later than 7 February 2022 in order to ensure supply from the beginning of the Purchase Period.

The Contracting Authorities shall be entitled to extend the framework agreement up to 2 times 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.

For

5

Procurement no.: 5

ATC Code: J01GB03

Generic name: Gentamicine

Strength: 1 mg/ml

Unit: 0,24 g

Volume in units: (Denmark 1.940) (Norway: 17.166) (Iceland: 400)

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. Reference is made to the tender specifications, including the provision on the list of products in general.

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”) and the Norwegian “Farmalogg” and the Icelandic “Lyfjaverðskrá” not later than 7 February 2022 in order to ensure supply from the beginning of the Purchase Period.

The Contracting Authorities shall be entitled to extend the framework agreement up to 2 times 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.

For

6

Procurement no.: 6

ATC Code: J01GB03

Generic name: Gentamicine

Strength: 3 mg/ml

Package: 80 ml

Unit: 0,24 g

Volume in units: (Denmark 24.580) (Norway: 62.620) (Iceland: 1.100)

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. Reference is made to the tender specifications, including the provision on the list of products in general.

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”) and the Norwegian “Farmalogg” and the Icelandic “Lyfjaverðskrá” not later than 7 February 2022 in order to ensure supply from the beginning of the Purchase Period.

The Contracting Authorities shall be entitled to extend the framework agreement up to 2 times 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.

For

7

Procurement no.: 7

ATC Code: J01GB03

Generic name: Gentamicine

Strength: 3 mg/ml

Package: 120 ml

Unit: 0,24 g

Volume in units: (Denmark 13.110) (Norway: 86.820) (Iceland: 1.350)

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. Reference is made to the tender specifications, including the provision on the list of products in general.

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”) and the Norwegian “Farmalogg” and the Icelandic “Lyfjaverðskrá” not later than 7 February 2022 in order to ensure supply from the beginning of the Purchase Period.

The Contracting Authorities shall be entitled to extend the framework agreement up to 2 times 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.

For

8

Procurement no.: 8

ATC Code: J01MA02

Generic name: Ciprofloxacin

Pharmaceutical form: Infusion fluid

Strength: 2 mg/ml

Package: 100 ml

Unit: 0,8 g

Volume in units: (Denmark 9.860) (Norway: 4.605) (Iceland: 60)

ATC Code: J01MA02

Generic name: Ciprofloxacin

Pharmaceutical form: Infusion fluid

Strength: 2 mg/ml

Package: 200 ml

Unit: 0,8 g

Volume in units: (Denmark 50.230) (Norway: 28.570) (Iceland: 1000)

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. Reference is made to the tender specifications, including the provision on the list of products in general.

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”) and the Norwegian “Farmalogg” and the Icelandic “Lyfjaverðskrá” not later than 7 February 2022 in order to ensure supply from the beginning of the Purchase Period.

The Contracting Authorities shall be entitled to extend the framework agreement up to 2 times 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.

For

9

Procurement no.: 9

ATC Code: J01XA01

Generic name: Vancomycin

Pharmaceutical form: Infusion fluid

Strength: 500 mg

Package:

Unit: 2 g

Volume in units: (Denmark 25.257) (Norway: 4.718) (Iceland: 10)

ATC Code: J01XA01

Generic name: Vancomycin

Pharmaceutical form: Infusion fluid

Strength: 1000 mg

Package:

Unit: 2 g

Volume in units: (Denmark 79.377) (Norway: 60.430) (Iceland: 9.832)

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. Reference is made to the tender specifications, including the provision on the list of products in general.

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”) and the Norwegian “Farmalogg” and the Icelandic “Lyfjaverðskrá” not later than 7 February 2022 in order to ensure supply from the beginning of the Purchase Period.

The Contracting Authorities shall be entitled to extend the framework agreement up to 2 times 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.

For

10

Procurement no.: 10

ATC Code: J01XD01

Generic name: Metronidazol

Pharmaceutical form: Infusion fluid

Strength: 5 mg/ml

Package:

Unit: 1,5 g

Volume in units: (Denmark 293.320) (Norway: 152.207) (Iceland: 10.333)

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. Reference is made to the tender specifications, including the provision on the list of products in general.

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”) and the Norwegian “Farmalogg” and the Icelandic “Lyfjaverðskrá” not later than 7 February 2022 in order to ensure supply from the beginning of the Purchase Period.

The Contracting Authorities shall be entitled to extend the framework agreement up to 2 times 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.

For

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 drawnup by Amgros in this respect and in the ‘Instructions for the European Single Procurement Document’ drawnup by the Danish Competition and Consumer Authority (Konkurrence- og Forbrugerstyrelsen). The successfultenderer(s) to whom the contracting authorities intend to award the framework agreement must also, beforethe award, provide documentation to the contracting authorities regarding the absence of compulsory grounds for 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 in sections 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 section 138 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 tenderers 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 whether 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 realisable with a further subdivision as well as costs and patient safety considerations related to the subsequent management 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 (‘ApotekernesIndkøbspris’ 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.