Varer - 616123-2021

03/12/2021    S235

Danmark-Viborg: Medicinsk udstyr, lægemidler og produkter til personlig pleje

2021/S 235-616123

Udbudsbekendtgørelse

Varer

Retsgrundlag:
Direktiv 2014/24/EU

Del I: Ordregivende myndighed

I.1)Navn og adresser
Officielt navn: Region Midtjylland
Postadresse: Skottenborg 26
By: Viborg
NUTS-kode: DK04 Midtjylland
Land: Danmark
Kontaktperson: Tolstrup & Hvilsted - Sanne Koefoed and Ivan Smedegaard Meic
E-mail: kontakt@tohv.dk
Telefon: +45 25194111
Internetadresse(r):
Overordnet internetadresse: https://rm.dk
I.3)Kommunikation
Udbudsmaterialet er gratis, ubegrænset og fuldt tilgængeligt på: https://www.ethics.dk/ethics/eo#/27613943-6e50-4723-b848-35c0d216ffdf/publicMaterial
Yderligere oplysninger fås på den ovennævnte adresse
Bud eller ansøgninger om deltagelse skal sendes elektronisk via: https://www.ethics.dk/ethics/eo#/27613943-6e50-4723-b848-35c0d216ffdf/homepage
Bud eller ansøgninger om deltagelse skal sendes til den ovennævnte adresse
Elektronisk kommunikation kræver anvendelse af værktøjer og anordninger, der ikke er almindeligt tilgængelige. Der er gratis, ubegrænset og fuld adgang til disse værktøjer og anordninger på: https://www.ethics.dk/ethics/eo#/27613943-6e50-4723-b848-35c0d216ffdf/homepage
I.4)Type ordregivende myndighed
Regional eller lokal myndighed
I.5)Hovedaktivitet
Anden aktivitet: Health

Del II: Genstand

II.1)Udbuddets omfang
II.1.1)Betegnelse:

Open procedure regarding an Autoclave for Hospitalsapoteket

Sagsnr.: ESDH sagsnr. 1-31-72-709-21
II.1.2)Hoved-CPV-kode
33000000 Medicinsk udstyr, lægemidler og produkter til personlig pleje
II.1.3)Kontrakttype
Varer
II.1.4)Kort beskrivelse:

This invitation to tender concerns the procurement of one (1) Autoclave including vacuum pump and steam generator, two (2) trolleys, one (1) carriage, one (1) carriage (option), service agreement (option) and training for Nyt Hospitalsapotek.

II.1.5)Anslået samlet værdi
II.1.6)Oplysninger om delkontrakter
Kontrakten er opdelt i delkontrakter: nej
II.2)Beskrivelse
II.2.2)Supplerende CPV-kode(r)
31100000 Elektriske motorer, generatorer og transformatorer
33190000 Diverse medicinske apparater og produkter
33191000 Udstyr til sterilisation, desinfektion og hygiejne
50400000 Reparation og vedligeholdelse af medicinsk udstyr og præcisionsudstyr
II.2.3)Udførelsessted
NUTS-kode: DK04 Midtjylland
Hovedudførelsessted:

Aarhus

II.2.4)Beskrivelse af udbuddet:

The Contraction Authority manufactures medicine for the hospital with reference to EU-GMP including BEK 477 (BEK nr. 477 af 08/05/2013 Bekendtgørelse om færdigtilberedning af lægemidler på sygehusapoteker). Furthermore, the Contracting Authority is delivering medicine to hospitals in the region and patients located at home.

In connection with the establishment of the new hospital pharmacy in Skejby (NHA) a new autoclave is to be purchased. The autoclave must be applied in the service production in a grade C clean room (see Eudralex – Volume 4 – Annex 1 Manufacture and Sterile Medicinal Products (Draft 2 December 2020) and Eudralex – Volume 4 – Chapter 3 Premises and equipment, 1. March 2015) for autoclaving utensils and for terminal sterilization of finished products.

This invitation to tender concerns the procurement of:

- One (1) Autoclave including vacuum pump and steam generator

- Two (2) trolleys

- One (1) carriage + one (1) carriage (option)

- Service Agreement (option), cf. Appendix C

- Training, cf. Draft for Contract section 1.7

II.2.5)Tildelingskriterier
de nedenfor anførte kriterier
Kvalitetskriterium - Navn: Functionality / Vægtning: 20%
Kvalitetskriterium - Navn: Data and testing / Vægtning: 30%
Pris - Vægtning: 50%
II.2.6)Anslået værdi
II.2.7)Varighed af kontrakten, rammeaftalen eller det dynamiske indkøbssystem
Slut: 01/07/2023
Denne kontrakt kan forlænges: nej
II.2.10)Oplysninger om alternative tilbud
Alternative tilbud vil blive taget i betragtning: nej
II.2.11)Oplysninger om optioner
Optioner: ja
Beskrivelse af optioner:

1. As an option the Contract Authority may activate the Service Agreement cf. Appendix C – Service Agreement in year 2,3 and 4.

2. As an option the Contract Authority may extend Service Agreement cf. Appendix C in year 5,6 and 7.

3. As an option the Contract Authority may extend Service Agreement cf. Appendix C in 8,9 and 10.

4. As an option the Contracting Authority has the opportunity to buy one carriage cf. Appendix J – Price List, tab A.

II.2.13)Oplysninger om EU-midler
Udbuddet vedrører et EU-finansieret projekt og/eller program: nej
II.2.14)Yderligere oplysninger

Del III: Juridiske, økonomiske, finansielle og tekniske oplysninger

III.1)Betingelser for deltagelse
III.1.1)Egnethed til at udøve en erhvervsaktivitet, herunder krav om optagelse i erhvervs- eller handelsregistre
Liste over og kort beskrivelse af betingelser:

Together with the tender the Tenderer must submit a completed version of the European Single Procurement Document (ESPD), in which the requested information referred to in Section III.1) must be provided.

The ESPD is a self-declaration form which serves as preliminary documentation that the Tenderer, other entities or the association meet(s) the criteria for exclusion, suitability and selection. This information must be verified later.

Part II: Information concerning the economic operator

Section A: Information about the economic operator

Section B: Information about the economic operator’s representatives

Section C: Information about reliance on the capacities of Other Entities (see Tender Conditions clause 2.2 for further details)

Section D: : Information concerning Subcontractors on whose capacity the economic operator does not rely

Part III: Exclusion Grounds

Section A: Grounds relating to criminal convictions

Section B: Grounds relating to the payment of taxes or social security contributions: If there are any outstanding payments, tick ‘Yes’ and state the outstanding amount.

Section C: Grounds relating to insolvency, conflicts of interest or professional misconduct:

- The Tenderer must confirm that the Tenderer is not covered by the mandatory exclusion grounds laid down in Section 135(1)-(3) and Section 136 of the Danish Public Procurement Act. Otherwise, the Contracting Authority is obliged to exclude the Tenderer, see, however, Section 135(4) and (5) of the Danish Public Procurement Act.

- The Tenderer must also confirm that the Tenderer is not covered by the following voluntary exclusion grounds, see Section 137(1) of the Danish Public Procurement Act:

- Matters concerning insolvency/bankruptcy/liquidation or the like, see para (2).

- Agreement aimed at distortion of competition, see para (4).

III.1.2)Økonomisk og finansiel kapacitet
Liste over og kort beskrivelse af udvælgelseskriterier:

The Tenderer must confirm the economic ability in the ESPD part IV.B:

1. The Tenderer must state ‘General yearly turnover’ for the financial statements for each of the last two (2) closed financial years at the time of the deadline for the tenders.

2. The Tenderer must state the equity as ‘Financial ratio’ for each of the last two (2) closed financial years at the time of the deadline for tenders, which is reported under ‘Description’.

Mindstekrav til det niveau, der muligvis kræves:

Concerning 1) It is a minimum requirement that the yearly turnover is minimum DKK five (5) mill. for each of the last two (2) closed financial years.

Concerning 2) It is a minimum requirement that the equity is minimum DKK two (2) mill for each of the last two (2) closed financial years.

III.1.3)Teknisk og faglig kapacitet
Liste over og kort beskrivelse af udvælgelseskriterier:

The Tenderer must confirm the technical and proffessional ability in the ESPD part IV.C:

The Tenderer must provide minimum two (2) references, cf. the minimum requirements below

The references must contain the following:

- Description: Description of the delivery with focus on the elements which make the reference comparable and compliant with the minimum requirements, see below. The description should also contain information about the date for approved delivery.

- Date: Date for start-up (commencement date) and date for completion (date for approved delivery)

- Recipients: Customer name incl. contact person and contact person’s telephone number.

If more references are provided, the Contracting Authority will only assess the four (4) latest references.

Mindstekrav til det niveau, der muligvis kræves:

It is a minimum requirement that the Tenderer holds at least two (2) references containing approved delivery of one or more autoclaves which operates in a GMP environment (in compliance with Eudralex vol. 4, Annex 1, Manufacture of Sterile Products, Draft 2 2020) within the last three (3) years.

- The delivery must have been approved within the last three (3) years calculated from the date of the deadline for tenders.

- The Contracting Authority will disregard references concluded (where delivery have been approved) more than three (3) years before the deadline for tenders.

III.2)Kontraktbetingelser
III.2.2)Kontraktudførelsesvilkår:

The parts of the autoclave must be delivered inside the building no later than the 1st of August 2022. The autoclave must be installed, tested and all necessary permits must be obtained no later than 1st of July 2023.

Del IV: Procedure

IV.1)Beskrivelse
IV.1.1)Proceduretype
Offentligt udbud
IV.1.3)Oplysninger om rammeaftale eller dynamisk indkøbssystem
IV.1.8)Oplysninger om GPA-aftalen om offentlige udbud
Dette udbud er omfattet af GPA-aftalen: ja
IV.2)Administrative oplysninger
IV.2.2)Frist for modtagelse af bud eller ansøgninger om deltagelse
Dato: 05/01/2022
Tidspunkt: 10:00
IV.2.3)Forventet dato for afsendelse af opfordringer til at afgive bud eller at deltage til udvalgte ansøgere
IV.2.4)Sprog, der må benyttes ved afgivelse af tilbud eller ansøgninger om deltagelse:
Dansk, Engelsk
IV.2.6)Minimumsperiode, i hvilken den bydende er forpligtet af sit bud
Varighed i måneder: 6 (fra den anførte dato for modtagelse af bud)
IV.2.7)Betingelser for åbning af bud
Dato: 05/01/2022
Tidspunkt: 10:00
Sted:

N/A

Oplysninger om adgangsberettigede personer og fremgangsmåde ved åbning af bud:

N/A

Del VI: Supplerende oplysninger

VI.1)Oplysninger om gentagelse
Dette er et tilbagevendende offentligt indkøb: nej
VI.2)Oplysninger om elektroniske arbejdsgange
Der vil blive anvendt elektronisk bestilling
Elektronisk fakturering accepteres
Der vil blive anvendt elektronisk betaling
VI.3)Yderligere oplysninger:

The Tenderer is requested to seek to clarify any unclear points and uncertainties by asking questions about the invitation to tender.

The Tenderer is responsible for keeping up to date on the documents in Ethics.

According to the time schedule in Tender Conditions clause 1.8, questions received before the questions deadline will be answered by the Contracting Authority, whereas questions received after the questions deadline will only be answered if the nature of the question does not make it disproportionately onerous for the Contracting Authority to answer the question within the response deadline.

Questions received later than seven days before the tender deadline, respectively, will generally not be answered.

Technical questions about the use of the Ethics must be submitted to the support: +45 70 22 70 07 or by clicking the icon “Kundeservice”.

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Tenderer, other entities and associations must, at the Contracting Authority’s request, submit documentation for the information provided in the ESPD

If the Tenderer, the association’s participants or other entities are from Denmark, the documentation is presented in the form of a service certificate from the Danish Business Authority. The service certificate must contain information from:

- The probate court under the Danish District courts

- The Danish Customs and Tax Administration

- The Danish Labour Market Supplementary Pension Fund (ATP)

- The Police (the Danish Central Crime Register)

- Please note that a ‘declaration of consent’ must be filled in, signed and uploaded when ordering the service certificate.

The service certificate is ordered from Virk.

The service certificate must be maximum six (6) months old from the date set by the Contracting Authority as the deadline.

The processing time with the Danish Business Authority is approximately two (2) weeks from when the order has been received.

If the Tenderer, one or more of the participants in the association or other entities is/are not from Denmark, the types of documentation stated in e-Certis must generally be produced. E-Certis is an online information system which is to be used to find the right documentation to be used by EU Member States in connection with invitations to tender and procurement procedures.

If these countries do not issue the relevant certificates or documents, or if the issued certificates or documents do not cover all the relevant cases, they can be replaced by a sworn declaration.

Such a sworn declaration is not used in the country in question, a solemn declaration may be used instead.

Information provided in the ESPD Part IV – Selection criteria is verified as follows:

- Information about key financial figures may be provided through financial statements or by presentation of a declaration unless the Contracting Authority can obtain the relevant information directly through access to a national database or the Contracting Authority already has the necessary documentation from previously implemented tendering procedures.

- Submission of documentation is not required for references; the Contracting Authority reserves the right to confirm the correctness of the references with the customers.

VI.4)Klageprocedurer
VI.4.1)Organ med ansvar for klageprocedurerne
Officielt navn: Klagenævnet for udbud
Postadresse: Toldboden 2
By: Viborg
Postnummer: 8800
Land: Danmark
E-mail: klfu@naevneneshus.dk
Telefon: +45 72405708
Internetadresse: https://erhvervsstyrelsen.dk/klagenaevnet-for-udbud
VI.4.3)Klageprocedure
Præcise oplysninger om klagefrist(er):

Complains must be filed with The Complaints Board for Public Procurement within:

1. 45 calendar days after the contracting authority has published a contract award notice in the Official Journal of the European Union (with effect from the day following the publication date);

2. 30 calendar days starting the day after the contracting authority has informed the tenderers in question, that the contracting authority has entered into a contract based on a framework agreement through reopening of competition or a dynamic purchasing system, provided that the notification includes a short account of the relevant reasons for the decision;

3. 6 months starting the day after the contracting authority has sent notification to the candidates/tenderers involved that the contracting authority has entered into the framework agreement, provided that the notification included a short account of the relevant reasons for the decision.

VI.4.4)Tjeneste, hvor der kan fås oplysninger om klageproceduren
Officielt navn: Konkurrence- og Forbrugerstyrelsen
Postadresse: Carl Jacobsens Vej 35
By: Valby
Postnummer: 2500
Land: Danmark
E-mail: kfst@kfst.dk
Telefon: +45 41715000
Internetadresse: www.kfst.dk
VI.5)Dato for afsendelse af denne bekendtgørelse:
29/11/2021