Open procedure regarding an autoclave for Hospitalsapoteket, Region Midtjylland

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.

Aarhus

The Contraction Authority manufactures medicine for the hospital with reference to EU-GMP. 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

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 year 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.

The Contracting Authority will hold an information meeting where the Contracting Authority will present the tender material and explain the background of the invitation to tender. The date of the information meeting is shown in the time schedule under Tender Conditions clause 1.9. Please see Tender Conditions 1.6.

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).

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’.

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.

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.

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 Medicinal Products) 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.

N/A

N/A

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 1.9, 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 reeived 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.

-

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.

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.