Consultancy and expertise services for the implementation of the ExpertRARE project

Requirement: Economic operators submitting tenders must prove a form of registration under the law of the State of residence, which shows that they are legally constituted, that they are not in any of the situations of cancellation and that they have the professional capacity to provide the services covered by the contract. For Romanian economic operators, the object of activity entered in the finding certificate issued by the ONRC must allow the provision of the services assumed by the tender. For non-patrimonial legal persons, authorised natural persons, institutions or other forms of organisation permitted by law shall be presented the equivalent documents resulting from the personality or legal capacity and the right to carry out those activities. Legal theme: Art. 173 para. (1) of Law No 98 / 2016. The requirement shall also apply to subcontractors, for the part of the contract they are to undertake, by filling in a separate DUAE. In the case of an association, the requirement shall be met by each member for the part of the contract he will perform. Method of implementation: complete DUAE. The supporting document - the finding certificate issued by the ONRC or equivalent documents issued in the country of residence, translated into Romanian - shall be submitted at the request of the Contracting Authority by the highest bidder after the award criterion has been applied. The information in the ONRC certificate shall be real and current at the date of presentation.

Requirement: Turnover. The average annual turnover of the tenderer for the last three financial years, namely 2023, 2024 and 2025, shall be at least equal to MDL 3.065.943. Legal basis: Art. 175 para. (2) letter a) and Art. 176 of Law No 98 / 2016. Justification, according to Articles 175 (2) and 176 of Law No 98 / 2016: the minimum level is relative to the estimated value of the contract and does not exceed double the contract. The requirement aims to have adequate economic capacity to support during the contract a multidisciplinary team of five key experts and support staff, parallel activities for seven partner entities and cash flow until quarterly payments are made. For economic operators established or having been active for less than three years, the average shall be calculated on the basis of the financial years available since the date of establishment or commencement of business. If, for objective and justified reasons, the economic operator cannot produce the required documents, it may demonstrate the economic and financial situation by other documents which the Contracting Authority considers appropriate. In the case of an association, the requirement shall be demonstrated by pooling the resources of the members without establishing a binding minimum weighting for the leader or a specific associate. The requirement may also be met by support granted by one or more third parties under the terms of the law. Method of delivery: complete the DUAE by all participating economic operators (tenderer, associate bidder, third party supporter). The supporting documents - the declaration of total turnover, annual or extracts from them, balance sheets or balance sheets, financial audit reports or other equivalent tax / accounting documents - shall be submitted at the request of the Contracting Authority by the highest bidder. With the support undertaking, the documents resulting from the actual way in which the third party will ensure the fulfilment of its own commitment, according to Article 182 (4) of Law No 98 / 2016. The Association Agreement shall be presented in accordance with Form No 5 and the binding commitment of the supporting third party to the economic and financial situation under Form No 8 of the Form Section.

Requirement - Similar experience. The tenderer shall provide proof that, in the last three years calculated by reference to the closing date for the submission of tenders, he has adequately provided similar services, the cumulative value of which is at least 3.065.943 lei without VAT. Legal theme: art. 179 letter b) of Law No 98 / 2016. The reference period shall be calculated in reverse from the closing date for the submission of tenders. If the Contracting Authority deletes the deadline, the lower limit of the three-year period shall be extended accordingly. For ongoing contracts only the part of services provided and received or duly confirmed during the reference period shall be taken into account. Similar services include advisory services, technical assistance and / or management services for the implementation of projects financed by European funds, national public funds or other international or public sources. In order to be considered relevant, a contract invoked must have included at least two of the following categories of activities: planning, coordinating and monitoring the implementation of a project; tracking of activities, deadlines, deliveries and dependencies; monitoring of indicators, collection and verification of data and preparation of progress reports; preparing, checking or operating information in an electronic project management and reporting system; financial support, budget monitoring and preparation and verification of documents related to financial applications; coordinating and centralising contributions from several partners or entities involved; supporting methodological documents, review and integration of documents, training programmes or digital content; ensuring quality, verification of documents and monitoring of observations. The projects invoked must not have had the same medical area, category of beneficiary or source of funding. The relevance shall be determined by the comparability of the activities actually performed, not by the contract name, CPV code or institutional scope of the beneficiary. Method of performance: complete the DUAE, specifying the number and date of the contract invoked, the object and activities performed, the value, the beneficiary, the period and the receipt document. The supporting documents shall be submitted at the request of the Contracting Authority, by the highest bidder, and may be: acceptance minutes or equivalent documents; recommendations or certificates of good performance; finding documents; certificates, certificates or acknowledgement of the beneficiaries; contracts or extracts from contracts only together with documents confirming the actual supply; other equivalent documents. The documents shall enable the subject matter of the contract and the activities actually performed, the beneficiary, the period of performance and, in the case of pending contracts, the applied party, the VAT-free value of the relevant services, the role of the economic operator, including the party carried out in association or subcontracting, and the fact that the services have been properly supplied. If the document does not show separately the value of similar services under a wider contract, the tenderer shall submit additional documents issued or confirmed by the beneficiary. The unilateral declaration of the tenderer is not sufficient. In the event of a delay in the deadline for submission of tenders, the three-year period shall refer to the new deadline, according to Article 13 (2) of the Instruction of President ANAP No 2 / 2017.

Application: Quality management standard. The tenderer shall demonstrate the implementation of a quality management system according to SR EN ISO 9001 or an equivalent standard for relevant activities in relation to the part of the contract it will perform. The certification shall be valid on the closing date for the submission of tenders. Legal basis: Art. 200 para. (1) and (2) of Law No 98 / 2016. Equivalent certificates issued by bodies established in other Member States shall be accepted. Under the terms of Article 200 (2) of Law No 98 / 2016, other evidence of equivalent quality assurance measures shall also be accepted where the economic operator has not had access to the certificate requested or has not had the opportunity to obtain it within the time limit, for reasons which are not attributable to it, provided that it demonstrates that the proposed measures comply with the level of quality assurance required. In the case of an association, the requirement shall apply to each member for the activities it will carry out. Specification of key experts: the minimum requirements for the five key experts are set out in Chapter 9 of the specification and are requirements of the technical proposal and performance of the contract. According to Article 179 (e) and Article 187 (3) (c) of Law No 98 / 2016, the qualification and experience of personnel actually designated for the performance of the contract are not used simultaneously as qualification criteria for the capacity of the economic operator; the additional specific professional experience of these experts is an assessment factor. The documents presented in the technical proposal for each of the five key experts are, at least, the following: the curriculum vitae assumed by the expert; the study diplomas and documents relating to specialisation, the right to practice, the qualifications or certifications applicable; the documents demonstrating the minimum professional experience and the experiences required to be scored under point IV.5; the declaration of availability and the commitment to participate in the performance of the contract (Form No 10 of the Form Section); the documents demonstrating the existing legal report or the manner in which the expert will be made available to the contract; the professional documents applicable and valid according to the requirements of Chapter 9 of the contract, respectively, the title of the medical or the title of the medical or primary evidence in the exercise of the medical profession. triviate the requirements of Chapter 9 of the specification, namely the title of physician specialist or primary in the medical genetic specialty and proof of the right to exercise the profession.