Danemarca – Pachete software de conformitate – Quality Management System (QMS) for the Regional Pharmacy in Region Midtjylland

Tenders will be opened in the electronic tendering system. Tenderers will not be permitted to attend the opening of tenders. Has the economic operator, to its knowledge, breached its obligations in the field of labour law? As referred to for the purposes of this procurement in national law, in the relevant notice or the procurement documents or in Article 18(2) of Directive 2014/24/EU. Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for terrorist offences or offences linked to terrorist activities, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Articles 1 and 3 of Council Framework Decision of 13 June 2002 on combating terrorism (OJ L 164, 22.6.2002, p. 3). This exclusion ground also includes inciting or aiding or abetting or attempting to commit an offence, as referred to in Article 4 of that Framework Decision. Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for child labour and other forms of trafficking in human beings, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 2 of Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims, and replacing Council Framework Decision 2002/629/JHA (OJ L 101, 15.4.2011, p. 1). It is a minimum requirement that the total annual turnover, i.e. the net turnover for the most recent financial year, amounts to at least DKK 10,000,000. Documentation requirements regarding annual turnover: As documentation of the amount of net turnover, the successful Tenderer must submit the following, depending on the category of company to which the Tenderer belongs: If the Tenderer is subject to statutory audit requirements: - If net turnover is stated in the annual reports: Approved annual reports accompanied by an auditor's report. - If net turnover is not stated in the annual reports: An auditor's review report or audit report confirming the amount of net turnover. If the Tenderer is not subject to statutory audit requirements: Either approved annual reports accompanied by an auditor's report or review report, or an auditor's review report confirming the amount of net turnover. Are the assets of the economic operator being administered by a liquidator or by the court? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract. Konkurrence- og Forbrugerstyrelsen Has the economic operator or an undertaking related to it advised the contracting authority or contracting entity or otherwise been involved in the preparation of the procurement procedure? See the tender specifications and appendix 1 and 1.a Quality Management System (QMS) for the Regional Pharmacy in Region Midtjylland Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for money laundering or terrorist financing, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 1 of Directive 2005/60/EC of the European Parliament and of the Council of 26 October 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing (OJ L 309, 25.11.2005, p. 15). Klagenævnet for Udbud If the contract is awarded to a group of economic operators (e.g. a consortium), the members of the group must assume joint and several liability and appoint a common authorised representative, see also appendix E. Is the economic operator in arrangement with creditors? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract. Quality Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for fraud, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? Within the meaning of Article 1 of the Convention on the protection of the European Communities' financial interests (OJ C 316, 27.11.1995, p. 48). It is a minimum requirement that the Tenderer has relevant experience in the form of at least one comparable reference within the past three years. A reference is considered comparable if it concerns the delivery of a QMS system to customers with pharmaceutical production under EU GMP regulation As documentation of the Tenderer's relevant experience, the successful Tenderer must submit a signed reference list. The Contracting Authority reserves the right to contact the listed references to verify the accuracy of the information provided. Has the economic operator breached its obligations relating to the payment social security contributions, both in the country in which it is established and in Member State of the contracting authority or contracting entity if other than the country of establishment? Mercell Holding ASA Is the economic operator bankrupt? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract. Is the economic operator in in any analogous situation like bankruptcy arising from a similar procedure under national laws and regulations? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract. Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for participation in a criminal organisation, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 2 of Council Framework Decision 2008/841/JHA of 24 October 2008 on the fight against organised crime (OJ L 300, 11.11.2008, p. 42). Has the economic operator entered into agreements with other economic operators aimed at distorting competition? Has the economic operator, to its knowledge, breached its obligations in the field of social law? As referred to for the purposes of this procurement in national law, in the relevant notice or the procurement documents or in Article 18(2) of Directive 2014/24/EU. See the tender specifications and appendix 5.a Is the economic operator guilty of grave professional misconduct? Where applicable, see definitions in national law, the relevant notice or the procurement documents. Has the economic operator breached its obligations relating to the payment of taxes, both in the country in which it is established and in Member State of the contracting authority or contracting entity if other than the country of establishment? Region Midtjylland Is the economic operator aware of any conflict of interest, as indicated in national law, the relevant notice or the procurement documents due to its participation in the procurement procedure? The Hospital Pharmacy intends to procure a new Quality Management System (QMS) to support and manage its GxP-regulated quality processes. The solution shall be a standard, modular and cloud-based SaaS solution supporting key quality processes, including change management, deviations, CAPA, complaints, recalls, training and supplier management. Is the economic operator the subject of insolvency or winding-up? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract. The procurement documents, including the tender conditions, are published via Mercell’s internet-based procurement system, “CTM”. Accordingly, the procurement documents, including any corrigenda, may be downloaded via https://eu.eu-supply.com/ctm/supplier/publictenders?B=REGIONMIDT. All communication concerning this procurement procedure must take place via CTM in accordance with the tender conditions and not via the Contracting Authority’s email address stated above. Access to the procurement documents and participation in the procurement procedure require online registration in CTM. Registration as a user of the system is free of charge. Once registered, the Tenderer must log in via the upper left-hand corner. An overview of all procurement procedures conducted by the Region will then be displayed. The relevant procurement procedure should be selected, after which the procurement documents will become available, including the appendices to be submitted as part of the complete tender. Please note that all actions taken by both the Contracting Authority and the [Tenderer/Applicant] are logged in the system. For technical questions concerning the use of the system, please contact Mercell Support by telephone on [telefon eliminat]. Questions concerning the procurement procedure itself must be submitted to the Contracting Authority via the questions and answers module in the system. The answers to such questions will be published in anonymised form in the system and will be accessible to all participants. See the tender specifications and appendix 2 and 2.a Price Has the economic operator, to its knowledge, breached its obligations in the field of environmental law? As referred to for the purposes of this procurement in national law, in the relevant notice or the procurement documents or in Article 18(2) of Directive 2014/24/EU. Has the economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein been the subject of a conviction by final judgment for corruption, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable? As defined in Article 3 of the Convention on the fight against corruption involving officials of the European Communities or officials of Member States of the European Union, OJ C 195, 25.6.1997, p. 1, and in Article 2(1) of Council Framework Decision 2003/568/JHA of 22 July 2003 on combating corruption in the private sector (OJ L 192, 31.7.2003, p. 54). This exclusion ground also includes corruption as defined in the national law of the contracting authority (contracting entity) or the economic operator A complaint must be submitted to the Danish Complaints Board for Public Procurement within 45 calendar days after the contracting entity has published a notice in the Official Journal of the European Union stating that the contracting entity has entered into a contract, and within 6 months after the contracting entity has entered into a framework agreement, calculated from the day after the date on which the contracting entity notified the affected candidates and tenderers. At the same time as the complaint is submitted to the Danish Complaints Board for Public Procurement, the complainant must send a copy of the complaint, including any appendices, to the contracting entity, preferably by email. Are the business activities of the economic operator suspended? This information needs not be given if exclusion of economic operators in this case has been made mandatory under the applicable national law without any possibility of derogation where the economic operator is nevertheless able to perform the contract. Detailed time schedule Can the economic operator confirm that:a) It has been guilty of serious misrepresentation in supplying the information required for the verification of the absence of grounds for exclusion or the fulfilment of the selection criteria,b) It has withheld such information,c) It has not been able, without delay, to submit the supporting documents required by a contracting authority or contracting entity, andd) It has undertaken to unduly influence the decision making process of the contracting authority or contracting entity, to obtain confidential information that may confer upon it undue advantages in the procurement procedure or to negligently provide misleading information that may have a material influence on decisions concerning exclusion, selection or award? DNK 01 Askekroken 11 72265000 allowed [email eliminat] none exg-mis-prep-confl required [telefon eliminat] [telefon eliminat] exg-mis-distortion exg-sitn-other supplies price 8800 11:00:00+00:00 Aarhus N Viborg effd5e27-17d8-4d6a-a120-1415db4c2777 exg-sitn-as-susp 15 16 DK042 DK041 29190925 ra quality 32014L0024 slc-abil-ref-supply per-exa exg-mis-bre-soc-law 6 2026-11-09+00:00 ••• ••• 00 exg-crim-fraud non-restricted-document 37795526 2026-11-11+01:00 55[telefon eliminat] eforms-sdk-1.13 exg-sitn-insolvency 48100000 Indkøb & Medicoteknik Indkøbsdokumenter https://naevneneshus.dk/naevnsoversigt/klagenaevnet-for-udbud/ https://www.rm.dk/om-os/info-til-samarbejdspartnere/udbud/ Nævnenes Hus, Tolboden 2 UNLIMITED 8200 exg-mis-partic-confl 7226[telefon eliminat] health 72268000 [email eliminat] services DAN exg-mis-bre-lab-law 0277 2.3 40 ted-esen open 4817[telefon eliminat] https://kfst.dk/udbud exg-crim-part DK012 2500 59744e8a-f492-466a-bc60-bc52d52b9f5e ORG-0003 ORG-0004 [telefon eliminat] cn-standard 15:30:59+00:00 ORG-0001 ORG-0002 Oslo exg-crim-traffick DKK [telefon eliminat] NO081 exg-sitn-bankr exg-crim-terror epo-notice no-eu-funds NOR exg-pmt-bre-tax https://eu.eu-supply.com/ctm/company/companyinformation/index/253854 slc-stand-to-gen true Olof Palmes Allé 15 [telefon eliminat] https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=461612&TID=200421964&B= ENG eSender no 72267000 http://mercell.com/ not-allowed 1-23-4-72-51-26 exg-mis-misrepresent LOT-0000 exg-sitn-liq-admin exg-mis-misconduct 2026-12-14+00:00 exg-mis-bre-env-law Carl Jacobsens Vej 35 exg-pmt-bre-ssc false 219/2026 [email eliminat] [email eliminat] 13:22:36+00:00 exg-crim-laund exg-sitn-cred-arran Valby [telefon eliminat] performance 393134-2026 exg-crim-corrpt Jeppe Askhim