Closing date: 14 th December Date published: 23 rd October Cost of document: 1 P a g e REFERENCE NUMBER: PML/05/2015

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1 MINISTRY FOR ENERGY AND HEALTH AUBERGE DE CASTILLE, VALLETTA, MALTA REFERENCE NUMBER: PML/05/2015 Prequalification Questionnaire (PQQ) for the award of a public service concession for the design, manufacture, delivery, installation, operation, training, maintenance and periodic upgrading of an automated single dose-system and smart cabinets for Pharmaceutical, Medical Materials and Surgical Devices for E-Prescribing and Medicines Administration (epma) to the Department of Health (Malta) Closing date: 14 th December 2015 Date published: 23 rd October 2015 Cost of document: N/A Clarifications shall be uploaded and will be available to view/download from 1 P a g e

2 TABLE OF CONTENTS Part 1 Introduction 3 Part 2 Instructions to interested candidates Instructions for the Prequalification Questionnaire 5 Part 3 The Prequalification Questionnaire 20 Section A General Administrative Information 20 Section B Technical Capacity 28 Section C Declarations by the Candidate 38 Section D Checklist of this PQQ 41 Appendix I Part III of Subsidiary Legislation Complaints 42 Appendix II Memorandum of Information 44 2 P a g e

3 PART 1 INTRODUCTION 1. In submitting a Prequalification Questionnaire (PQQ), the Candidate accepts in full and in its entirety, the content of this document, including subsequent clarifications issued by the Administrator, whatever his own corresponding conditions may be, which he hereby waives. Candidates are expected to examine carefully and comply with all instructions, forms, contract provisions and specifications contained in this Prequalification Questionnaire document. This is a Prequalification Questionnaire (PQQ) for the award of a public service concession for the design, manufacture, delivery, installation, operation, training, maintenance and periodic upgrading of an automated single dose-system and smart cabinets for Pharmaceutical, Medical Materials and Surgical Devices for E-Prescribing and Medicines Administration (epma) to the Department of Health (Malta) No account can be taken of any reservation in the Prequalification Questionnaire, Memorandum of Information and the Invitation to Dialogue; any disagreement, contradiction, alteration or deviation shall lead to the offer not being considered any further. 2. Brief overview of this PQQ Document and the Concession Process The intention of this PQQ document is to guide interested Candidates in providing the necessary information for the assessment of their financial standing and technical capacity to provide the services required. The financial information obtained from the submission of the appropriate template and supporting documentation allows the Evaluation Committee to verify and evaluate that a Candidate has adequate financial and other resources and will be in a position to continue to deliver the services throughout the contract period. The technical information allows the Committee to assess whether a Candidate has the relevant skills, experience and business practices to provide the services to meet the Client s requirements as specified in the Memorandum of Information provided in Appendix II to this document. The Evaluation Committee will review each submission against the shortlisting criteria provided in Part 2 (Stage 1). The shortlisted candidates will then receive an Invitation to Participate in a Competitive Dialogue (ITPD) with the appointed Evaluation Committee, inviting them to submit outline solutions and open a dialogue with the Candidates (Stage 2A). Following the evaluation of the presented solutions, the Committee will shortlist the solutions and open more detailed dialogue on the technical, financial and legal aspects of these options, the aim of identifying and defining the means best suited to satisfying the needs and requirements of the Client (Stage 2B). At the end of the Dialogue Process, the shortlisted Candidates will be invited to submit a detailed proposal (best and final offer) based on the solutions presented and specified during the dialogue (Stage3) through a restricted competitive process. These proposals shall contain all elements required and necessary for the performance of the contract. These bids will then be assessed on the basis of the award criteria laid down in the contract notice or the descriptive document. 3. The Prequalification Questionnaire (Part 3 of this document) is subdivided into four sections: General Administrative Information, Technical Capacity, Declarations by the Candidate, and Checklist. Candidates must fill in all sections. 3 P a g e

4 The Evaluation Committee shall request rectifications in respect of incomplete/non-submitted information pertinent to the documentation as outlined in: Section A General Administrative Information; Section C Declarations by Applicants; and Section D Checklist of the PQQ. Such rectification/s must be submitted within two (2) working days from notification, and will be subject to a non-refundable administrative penalty of 50. Failure to comply shall result in the PQQ not being considered any further. No rectification shall be allowed in respect of the documentation as outlined in Section B Technical Capacity. Only clarifications on the submitted information in respect of the latter may be eventually requested. 4. The Memorandum of Information (MOI) is attached to this document as Appendix 2. The MOI provides further detail about the whole project. It is recommended that the Candidates complete this PQQ after having taken all information provided into consideration. 5. The Final Beneficiary for this Competitive Dialogue procedure is the Central Procurement & Supplies Unit on behalf of the Department of Health within the Ministry for Energy and Health of Malta (hereinafter referred to as Client ). The Administrator of this Competitive Dialogue procedure is Projects Malta Limited. 4 P a g e

5 PART 2 INSTRUCTIONS TO INTERESTED CANDIDATES INSTRUCTIONS FOR THE PREQUALIFICATION QUESTIONNAIRE PROCESS 1. Timetable Prequalification Questionnaire (definite timetable) (Stage 1) Date Time Deadline for request for any clarifications from the Administrator 2 nd December pm (CET) Last date on which clarifications are issued by the Administrator 7 th December pm (CET) Deadline for submission of Prequalification Questionnaire Opening Session of Prequalification Questionnaires Prequalification Questionnaire Validity Period 14 th December am (CET) 14 th December am (CET) 13 th March 2016 Competitive Dialogue (indicative timetable) Stage 2A Date Invitation to Participate in Dialogue 11 th January 2016 Site visit/s Deadline for submission of initial solutions Dialogue meetings 21 st / 22 nd January th February 2016 Week starting 15 th February 2016 Shortlisting of initial solutions 29 th February 2016 Competitive Dialogue (indicative timetable) Stage 2B Invitation to participate in Dialogue on detailed solutions Deadline for submission of detailed solutions Dialogue meetings Date 1 st March th March 2016 Week starting Time Time 5 P a g e

6 21 st March 2016 Best and Final Offer (indicative timetable) Stage 3 Publication of document inviting the submission of the Best and Final Offer Deadline for submission of Best and Final Offer Date 28 th April th May 2016 Notification of award 23 rd June 2016 Time 2. Eligibility Participation in this Prequalification Questionnaire is open on equal terms to all natural and legal persons of the Member States of the European Union, the beneficiary country and any other third country. Once the short-listing process is carried out, participation in the remaining part of the competitive process will be only open to firms who have been invited by the Administrator. Proposals and responses to the Invitation to Dialogue should be submitted by the same entity which has submitted the reply to the prequalification questionnaire on the basis of which it was selected and to which the letter of the Invitation to Dialogue is addressed. No change whatsoever in the identity or composition of the Candidate is permitted during any stage of this competitive process. Natural persons, companies or undertakings who fall under any of the conditions set out in Article 50 of the Public Procurement Regulations (Subsidiary Legislation ) may be excluded from participation in and the award of contracts. Candidates who have been guilty of making false declarations will also incur financial penalties representing 10% of the total value of the contract being awarded. Eligible Candidates to this PQQ Dossier from combinations of firms as Joint Ventures or Consortia, will be accepted, provided that the Joint Venture (JV) or a Consortium Agreement is established to regulate the affairs of the interested parties, and that each JV partner or Consortium Partner recognises that he will be individually capable and contractually responsible (jointly and severally liable) for completion of the Project, should any one or more partner in the JV or Consortium fail or retire from the contract for any reason. The relative JV or Consortium Agreement is to be submitted with the Prequalification Questionnaire and will be kept valid until the relative contract has been signed between the Client and the successful Candidate. PQQs submitted by companies forming a joint venture/consortium must also fulfil the following requirements: One partner must be appointed lead partner and that appointment confirmed by submission of powers of attorney signed by legally empowered signatories representing all the individual partners. The Candidates must include a preliminary agreement or letter of intent stating that all partners assume joint and several liability for the execution of the contract, that the lead partner is authorised to bind, and receive instructions for and on behalf of, all partners, individually and collectively. 6 P a g e

7 All partners in the joint venture/consortium are bound to remain in the joint venture/consortium until the conclusion of the evaluation procedure. The consortium/joint venture winning this contract must include the same partners for the whole performance period of the contract other than as may be permitted or required by law. 3. Explanations, Clarification Notes concerning the PQQ document Candidates may submit questions in writing to the Administrator by sending an to up to 12 calendar days before the deadline for submission of the PQQs, quoting the reference number PML/05/2015. The Administrator must reply to all Candidates' questions, and amend the PQQ by publishing clarification notes, up to at least 6 calendar days before the deadline for submission of PQQs. Questions and answers, and alterations to the tender document will be published as a clarification note on the website of Projects Malta Ltd (above). Clarification notes will constitute an integral part of the Prequalification Questionnaire documentation, and it is the responsibility of Candidates to visit this website and be aware of the latest information published online prior to submitting their Prequalification Questionnaire. 4. PQQ shortlisting criteria In order to be considered eligible for the invitation to participate in dialogue stage, Candidates must obtain at least 70% of the marks. Shortlisted Candidates will be ranked according to the overall marks. All candidates who have obtained the minimum passmark shall be shortlisted and invited to the dialogue stage. In any event the number of candidates invited shall be sufficient to ensure competition. 5. Composition of Candidates A company may not compete for a given contract both individually and as a partner in a joint venture/consortium. A company may not submit a proposal for a given contract both individually/partner in a joint venture/consortium, and at the same time be nominated as a sub-contractor by any another tenderer, or joint venture/consortium. A company may act as a sub-contractor for any number of Candidates, and joint ventures/consortia, provided that it does not participate individually or as part of a joint venture/consortium, and that the nominations do not lead to a conflict of interest, collusion, or improper practice. Eventual proposals should be submitted by the same contractor or consortium which has been invited in this competitive dialogue procedure. 7 P a g e

8 6. Expenses Candidates will bear all costs associated with the preparation and submission of the response to the Prequalification Questionnaire and throughout the Competitive Dialogue procedure should the Candidate be shortlisted. The Administrator and the Client will neither be responsible for, nor cover, any expenses or losses incurred by the Candidate through site visits and inspections or any other aspect of his offer. It is being stated that 20,000 representing administrative costs related to this competitive process shall be payable to the Administrator (Projects Malta Ltd) by the successful Candidate upon entering into the Concession Agreement. 7. Language of the PQQ All correspondence and documents related to the Prequalification Questionnaire submitted by the Candidate to the Administrator must be in the English language. Supporting documents and printed literature furnished by the Candidate may be in another language, provided they are accompanied by an accurate translation into English. For the purposes of interpretation of the Prequalification Questionnaire, the English language will prevail. 8. Law By submitting the Prequalification Questionnaires, Candidates are accepting that this procedure is regulated by Maltese Law, and are deemed to know all relevant laws; acts and regulations of Malta that may in any way affect or govern the operations and activities covered by the PQQ and the resulting contract. Particular attention is drawn to the conditions concerning the employment of labour in Malta and the obligation to comply with all regulations, rules or instructions concerning the conditions of employment of any class of employee. For information purposes only, the selected bidder will be working under the Goods Manufacturing Practices and Goods Delivery Processes as set out in Act 458 of the Laws of Malta and Subsidiary Legislation Therefore, the organisation will eventually be expected to render itself compliant with such Laws/Regulations after award of the concession. 9. Currency The currency of the Prequalification Questionnaire and all other accompanying documentation is the euro except when otherwise instructed. 8 P a g e

9 The exchange rate applicable shall be the exchange rate as at the publication date of this PQQ and this official rate used shall be quoted. Certified/audited accounts may be given in the national currency if requested. 10. Period of validity of the PQQ PQQ submissions must remain valid for a period of 90 days after the deadline for submission of PQQ as indicated in the contract notice, or as modified in accordance with Part 2 Clause 3 and/or Part 2 Clause 14. Any Candidate who quotes a shorter validity period will be rejected. In exceptional circumstances, the Administrator may request that Candidates to extend the validity of PQQ submissions for a specific period. Such requests and the responses to them must be made in writing. If the Candidate decides to accede to the extension, he may not modify his PQQ. From the date of notification of shortlisting, shortlisted Candidates shall be required to extend the validity of their PQQ valid for a further period of 90 days. 11. Bid Bond No bid-bond is requested at this PQQ stage. However, shortlisted Candidates may be requested to submit a participation guarantee as part of the requirements of Stage 2 (Invitation to Participate in Dialogue) of this Competitive Dialogue procedure. 12. Preparation and signing of PQQ A complete Prequalification Questionnaire must be prepared in one (1) original, clearly marked original and one (1) identical copy (including all documentation as in the original) signed in the same way as the original and clearly marked copy. It is the responsibility of the Candidate to ensure that both the original and the copy are an identical representation of one another. In the event of any discrepancy between the original and the copy, the original will prevail. Both documents are to be separately sealed and placed in another sealed envelope/package so that the bid can be identified as one submission. Following the opening session, the copy shall be kept, unopened, at Projects Malta Ltd, for verification purposes only should the need arise. Candidate s submission must be typed in, or handwritten in indelible ink. Any pages on which entries or corrections to his submission have been made must be initialled by the person or persons signing the PQQ. All pages must be numbered consecutively by hand, machine or in any other way acceptable to the Administrator. 9 P a g e

10 The Prequalification Questionnaire must not contain any changes or alterations, other than those made in accordance with instructions issued by the Administrator. In such cases, alterations must be initialled by the person signing the Prequalification Questionnaire. A Prequalification Questionnaire submitted by any Candidate will be rejected if it contains any alterations, additions or deletions to this document, which are not specified in a clarification note issued by the Administrator. Candidates must indicate where their documentation is to be found in their offer using an index. All documentation is to be securely bound/filed. 13. Sealing and marking of PQQ The complete Prequalification Questionnaire is to be submitted in English and deposited in the Administrator s tender box before the deadline specified in the timetable above EITHER by recorded delivery (official postal service) OR hand delivered to: Projects Malta Ltd. The Clock Tower Level 1 Tigne Point Sliema TP01 Malta Europe Prequalification Questionnaires submitted by any other means will not be considered. Complete Prequalification Questionnaire, including annexes and all supporting documents (original and copy), must be submitted in a sealed envelope/package/s bearing only: a) the above address; b) the reference number of the invitation to this PQQ (PML/05/2015); c) the name of the Candidate. d) the words Not to be opened before 14 th December, 2015, 10.00am CET 14. Extension for the deadline for the submission of the PQQ The Administrator may, at its own discretion, extend the deadline for submission of Prequalification Questionnaires by issuing a clarification note in accordance with Part 2 Clause 3. In such cases, all rights and obligations of the Administrator and the Candidate regarding the original date specified in the contract notice will be subject to the new date. 15. Late submission of the PQQs All Prequalification Questionnaires received after the deadline for submission specified in the contract notice or these instructions will be kept by the Administrator. 10 P a g e

11 No liability can be accepted by the Administrator for late delivery of Prequalification Questionnaires. Late Prequalification Questionnaires will be rejected and will not be evaluated. 16. Alterations and withdrawal of PQQs Candidates may alter or withdraw their Prequalification Questionnaires by written notification prior to the deadline for submission. No Prequalification Questionnaire may be altered after such deadline. Any notification of alteration or withdrawal must be prepared, sealed, marked and submitted in accordance with Part 2 Clauses 12 and 13, and the envelope must also be marked with "alteration" or "withdrawal". 17. Opening of PQQs The Prequalification Questionnaires will be opened in a public session as specified in the Timetable above in Part 2 Clause 1 (or as otherwise specified in accordance with Part 2 Clause 3 and/or Part 2 Clause 14) at Projects Malta Ltd, The Clock Tower, Tigne Point, Sliema, Malta, Europe, by an Opening Committee appointed by the Administrator. The Opening Committee will draw up a Summary of the Prequalification Questionnaires Received which will be published on the notice board at the premises of Projects Malta Ltd (address above) and on its respective website ( During this session, the Candidates' names, written notification of modifications and withdrawals and any other information the Administrator may consider appropriate will be published. Envelopes marked "withdrawal" will be read out first and returned to the Candidate 18. Appointment of an Evaluation Committee An Evaluation Committee shall be set up to perform the evaluation of all submissions at all relevant stages of this Concession procedure and to conduct the Dialogue. During its evaluation, the Evaluation Committee may be assisted by any other person, officer, authority, entity, advisors, or consultants which or whom the evaluation committee may wish to engage for this purpose. 19. Secrecy of the procedure After the opening of the Prequalification Questionnaires, no information about the examination, clarification, evaluation or comparison of the opened Prequalification Questionnaires may be disclosed before the notification of the Shortlisted Candidates. 11 P a g e

12 Information concerning checking, explanation, opinions and comparison of Prequalification Questionnaires may not be disclosed to Candidates or any other person not officially involved in the process unless otherwise permitted or required by law. Any attempt by a Candidate to approach any member of the Evaluation Committee / Administrator directly during the evaluation period will be considered legitimate grounds for disqualifying the said Candidate s Prequalification Questionnaire submission. 20. Clarification of PQQs Prequalification Questionnaires which are incomplete, conditional, illegible, or contain other irregularities in contravention of this PQQ shall be rejected. When checking and comparing the Prequalification Questionnaires, the Evaluation Committee may, ask a Candidate to clarify any aspect of the relative Prequalification Questionnaire. Such requests and eventual responses must be made by or fax. Such responses may in no circumstances alter or try to change the content of the Prequalification Questionnaire. 21. Checking of PQQs Before beginning a detailed analysis of the Prequalification Questionnaires, the Evaluation Committee will check that each Prequalification Questionnaire: has been signed; complies with the requirements of this PQQ Dossier. If a Prequalification Questionnaire does not comply with the requirements of this document, it shall be rejected by the Evaluation Committee when determining its admissibility. 22. Evaluation of PQQs The Evaluation Committee shall evaluate and compare only those Prequalification Questionnaires considered compliant in accordance with the rules laid down in this PQQ Dossier. 23. Right of the Administrator to accept or reject any PQQ The Administrator reserves the right to accept or reject any Prequalification Questionnaire and /or to cancel the whole concession procedure and reject all Prequalification Questionnaires. The Administrator reserves the right to initiate a new concession procedure. In the event of a Prequalification Questionnaire procedure's cancellation, Candidate/s will be notified by the Administrator. Cancellation may occur where: a) the short-listing procedure has been unsuccessful, namely where, the Administrator is of the opinion that no qualitatively or financially worthwhile Prequalification Questionnaire has been received or there has been no response at all; 12 P a g e

13 b) the economic or technical parameters of the Project have been fundamentally altered; c) exceptional circumstances or force majeure render normal performance of the Project impossible; d) there have been irregularities in the procedure, in particular where these have prevented fair competition; and e) for any other justifiable reason. In no circumstances will the Authority, the Client, the Evaluation Committee and any other other person, officer, authority, entity, advisors, or consultants which or whom the Evaluation Committee may wish to engage during evaluation be liable for damages, of whatever nature (in particular for damages for loss of profits) in relation to the cancellation of this concession procedure. The publication of a contract notice does not commit the Administrator or the Client to implement the programme or Project announced. 24. PQQ Evaluation process Part 1 Administrative Compliance The Evaluation Committee will check the compliance of Prequalification Questionnaires with the instructions given in the PQQ dossier, and in particular the documentation submitted in respect of Sections A to D. The Evaluation Committee shall, request rectifications in respect of incomplete/non-submitted information pertinent to the documentation as outlined in: Section A General Administrative Information; Section C Declarations by the Candidate; and Section D - Checklist of this PQQ. Such rectification/s must be submitted within two (2) working days from notification, and will be subject to a non-refundable administrative penalty of 50. Failure to comply shall result in the PQQ not being considered any further. No rectification shall be allowed in respect of the documentation as outlined in Section B Technical Capacity of this PQQ. Only clarifications on the submitted information in respect of the latter may be eventually requested. Part 2 Technical Compliance Each Prequalification Questionnaire will be evaluated in accordance with the shortlisting criteria and the associated weighting as detailed in the evaluation grid of this Prequalification Questionnaire document. No other shortlisting criteria will be used. The shortlisting criteria will be examined in accordance with the requirements as indicated in Section B. PQQs which have been considered administratively compliant shall be evaluated for technical compliance as outlined below. 13 P a g e

14 PQQ submissions will be evaluated by using a scoring system. Questions in Section A, C and D shall not be subject to the scoring system. Only questions in Section B of the PQQ will be assessed and allocated a mark as identified in the questions themselves, the remaining sections will not have any bearing on the Evaluation process. The evaluation criteria are split in four: I. Financial Standing; II. General III. Capability of the proposed staff IV. Experience of the Candidate. These have been divided further into sub-criteria. Each sub-criterion has been allocated a number of Maximum Points to signify the relative importance of each area. In order to qualify, Candidates must obtain at least 70% of the overall marks. Shortlisted Candidates who rank as outlined in Part 2 Clause 4 - PQQ Shortlisting Criteria shall be invited by the Client for the next stage Invitation to Participate in Dialogue. 25. Notification of shortlisted Candidates to all Candidates Prior to the expiration of the period of validity of the Prequalification Questionnaires, the Administrator will notify all Candidates, in writing, whether their Prequalification Questionnaires have been shortlisted, pending any complaint being lodged in terms of Part III of the Concessions Review Board Regulation (being reproduced in Appendix 1). Candidates shall be notified with the outcome of the evaluation process, and will be provided with the following information: i. the criteria for shortlisting; ii. the names of the shortlisted Candidates; iii. the score obtained by the unsuccessful Candidate, and the scores of the successful Candidates; iv. the reasons why the Candidate did not meet the requirements; v. the deadline for filing a notice of objection (appeal); vi. the deposit required if lodging an appeal. The Administrator will also issue the Invitation to Participate in the Dialogue to all shortlisted Candidates, who will inter alia be invited to submit a preliminary solution/s and subsequently a Best and Final Offer in accordance with the rules of the Invitation to Participate in Dialogue. 26. Ethics clauses i. Any attempt by a Candidate to obtain confidential information, enter into unlawful agreements with competitors or influence the Evaluation Committee or the Administrator during the process of examining, clarifying, evaluating and comparing Prequalification Questionnaires will lead to the rejection of his submission and may result in administrative penalties. 14 P a g e

15 ii. The Candidate must refrain from making public statements about the project or services without the Administrator s/client's prior approval. He may not commit the Administrator/Client in any way without prior written consent. iii. The Candidate and his staff must not exercise any activity or receive any advantage inconsistent with their obligations to the Administrator/Client. iv. The Candidate and his staff are obliged to maintain professional secrecy for the duration of the competitive dialogue and after its completion. All reports and documents drawn up or received by the Candidate are to be kept confidential. v. The Candidate shall refrain from any relationship likely to compromise his independence or that of his staff. If the Candidate ceases to be independent, the Administrator may, regardless of injury, reject the Candidate s submission without further notice and without the Candidate having any claim to compensation. vi. The Administrator reserves the right to disqualify a Candidate if found guilty of corrupt practices of any kind by a competent authority. For the purposes of this provision, "corrupt practices" are the offer of a bribe, gift, gratuity or commission to any person as an inducement or reward for performing or refraining from any act relating to the award of a contract or implementation of a contract already concluded with the Administrator. vii. The offer of the Candidate/s concerned will be rejected if it emerges that his short-listing has given rise to unusual commercial expenses, such as undue commissions relating to this project. 15 P a g e

16 27. Evaluation Criteria Main Criteria Evaluation criteria Sub-criteria (further details below) Maximum points 1. Financial Standing 2. General 3. Capability (of the proposed staff) 4. Past deliveries (by the Candidate) 1a. Average turnover over the past three financial years. 1b. Average turnover over the past three financial years from services/supplies/works for the pharmaceutical and medical supplies automation sector. 2a. Equality Policy 3 2b. Environmental management policy 3 2c. Health and safety policy 4 3a. Qualifications in the five key areas 10 3b. Number of years in employment in the pharmaceutical/medical supplies automation sector and number of projects involved in. 4a. List of principal deliveries by the Candidate to the pharmaceuticals and medical supplies automation sector over the past 5 years. 4b. Evidence of support provided by the Candidate TOTAL P a g e

17 Sub-criteria Breakdown of points 1a. Average turnover over the past three financial years (max. 15 points). Average turnover over the past three financial years. Points 30m or more 15 20m and more but less than 30m 10 10m and more but less than 20m 5 Less than 10m 0 1b. Average turnover over the past three financial years from services/supplies/works for the pharmaceutical and medical supplies automation sector (15 points). Points 10m or more 15 8m and more but less than 10m 10 5m and more but less than 8m 5 Less than 5m 0 2. General Policies (10 points) 2a. Proof of an Equality Policy or equivalent 3 2b. Proof of an environmental management policy or equivalent 3 2c. Proof of a Health and Safety policy or equivalent 4 3a. Qualifications of the proposed staff in the five key areas, as attested by the CV (10 points). Medical or Pharmaceutical 2 Project Management 2 Engineering 2 Information and Communication Technology 2 Logistics & Supplies 2 17 P a g e

18 Points will be broken down in the following order: Qualifications equivalent to MQF Levels 6-8 (e.g. Doctoral/Post Doctoral, Masters, Post Graduate Diploma or Post Graduate Certificate, Bachelors Degree): 2 points Qualifications equivalent to MQF Levels 4-5 (e.g. Undergraduate Diploma, VET Higher Diploma, Matriculation Certificate, VET Diploma): 1 point Other levels: 0 points In case of doubt on the classification and equivalency of the qualifications presented, the Evaluation Committee will be referring to the Malta Qualifications Recognition Information Centre (MQRIC) for clarification. More information on the Malta Qualifications Framework may be obtained from the website of the National Commission for Further and Higher Education ( The Evaluation Committee also reserves the right to verify the information provided by requesting the submission of certificates or by enquiring the respective educational institutions. A person may be nominated for a maximum of two work areas. However, only a maximum of 2 points shall be awarded for the same person (i.e. points will not be doubled). 3b. Years of employment in the pharmaceutical/medical supplies automation sector and number of projects the employee was involved in (10 points) Maximum points for each person nominated (maximum 5 persons, maximum 1 person per key area) Points Either 10 years (+1 related project) or 5 projects in pharmaceutical/medical supplies automation sector 2 Either 5 years (+1 related project) or 2 projects in pharmaceutical/medical supplies automation sector 1 Less than 5 years 0 The persons nominated under both sub-criteria 3a and 3b need to be the same. If a person is nominated for two work areas, only a maximum of 2 points shall be awarded for the same person (i.e. points will not be doubled). 18 P a g e

19 4a. List of Principal Deliveries by the Candidate of a pharmaceutical and medical supplies automation nature over the past five years (30 points) Points for each project up Project Value to a maximum of five projects 5m or more 6 2.5m and more but less than 5m 3 Less than 2.5m 2 At least two reference letters are to be provided. The Evaluation Committee reserves the right to verify this information with the client. 4b. Evidence of support provided to the pharmaceutical and medical supplies automation sector (10 points) I. Please provide information about ongoing/after-sales support (e.g. on-the-spot technical support, phone support, online software updates) provided by your company. A description of support offered and a list of European clients who make use of such support shall be included. II. Please provide reference letters from two clients (at least one located in Europe) who received such support including information with regards to efficiency of response and effectiveness of response. Points will be allocated as follows: Evidence (reference letter 1) of support provided to at least one organisation located in Europe Evidence (reference letter 2) of support provided to at least one other organisation located in Europe or located worldwide 5 5 No marks will be allocated in the case of any missing information. The evaluation committee reserves the right to verify by contacting the clients directly. 19 P a g e

20 PART 3 THE PREQUALIFICATION QUESTIONNAIRE This Part is to be filled in by the Candidate. All supporting documentation should be clearly labelled with the Question it aims to support. SECTION A GENERAL ADMINISTRATIVE INFORMATION FORM Details of Candidate. The Candidate submitting this application must be the same legal entity with which the Client shall sign the contract. Name of Candidate Postal Address Town/City Postcode Country Website Legal Status (limited company, public limited company, partnership, etc) Registered Office Place of formation Date of formation 20 P a g e

21 Company Registration number (if registered in Malta) If the Candidate (including all partners) is not registered in Malta, please indicate. Relevant proof of incorporation from the respective country (certificates or equivalent) must be submitted with this questionnaire, for all relevant partners. Brief Description of the Candidate s primary business and main products and services (not more than 100 words). Brief history of the Prospective Bidder s organization, including details of any parent and associated companies and any changes of ownership over the last 5 years including details of significant pending developments, changes in financial structure or ownership, prospective take-over bids, mergers, etc which are currently in the public domain (maximum 400 words). The Evaluation Committee reserves the right to verify the information given from public records at the Malta Financial Services Authority, the VAT Department, the Inland Revenue Department, the Treasury and other relevant public departments, authorities or entities. 21 P a g e

22 2. Is the Candidate a Joint Venture/Consortium? Yes No If yes, please fill in Form Ownership Structure Provide a chart illustrating the ownership structure of the Candidate, including relations to any parent or other group or holding companies. In the case of Joint Ventures/Consortia, this is to be provided for all partners listed in Form Organisation Structure Attach an organisation chart with details relevant to this bid, showing the Candidate structure, including the positions of directors and key personnel. The chart shall also include the role and reporting structures between the Lead Partner, other partners and subcontrators. 5. Staff complement Provide details of your current staff complement (all partners), indicating total number of employees and the percentage of employees per department. 22 P a g e

23 Please outline staff complement your company/ies would allocate in response to this PQQ including details of their skills in the main work areas: Medical/Pharmaceutical, Project Management, Engineering, Information and Communication Technology and Logistics. 6. Ongoing projects Please provide information about the current projects your company/ies is/are undertaking. 23 P a g e

24 7. Details of main contact person. Name Position Telephone number Mobile phone number Fax Number 8. Authorised signatory Please attach the Power of Attorney, Board Resolution, or other document empowering and authorising the person signing this Prequalification Questionnaire on behalf of the Candidate to so act. 9. Insurances Please provide details of the Candidate s: (a) employers' liability, (b) public liability; and (c) professional indemnity insurances. The details should include the name of the insurers, type of insurance, policy numbers, expiry dates and limits for any one incident and annual aggregate caps and the excesses under the policies. Please note that Candidates are required to demonstrate, for each type of insurance, a minimum cover of 5 million for any one incident without limit on the number of incidents or reduction in cover or alternative but equivalent bases of insurance satisfactory to the Client. 24 P a g e

25 Name of insurer Address Type of insurance Policy numbers Expiry date Limits of indemnity (per occurrence and aggregate) Excess (if any) (*repeat table for each type of insurance, as applicable) Although not required to be submitted with this PQQ, the Evaluation Committee reserves the right to request official documentation/certificates supporting the above. 10. Litigation Please provide a statement of any material pending or threatened litigation or other legal proceedings where the claim is of a value in excess of 250,000. Disclosure of legal proceedings (maximum 300 words) Either insert required details or state None 25 P a g e

26 FORM Data on Joint Venture/Consortium 1 Name 2 Managing Board s Contact Details... Address: Telephone:... Fax: Agency in the State of the Client, if any (in the case of a Joint Venture/Consortium with a foreign lead partner) Address: Telephone:... Fax: Names of Partners (i)... (ii)... (iii)... (iv)... 5 Name of Lead Partner... 6 Agreement governing the formation of the Joint Venture/Consortium (Enclose Joint Venture/ Consortium Agreement) Place of Signature: Date of Signature: Proposed proportion of responsibilities between partners (in %) with indication of the type of the works to be performed by each % % % % 26 P a g e

27 Signature:... (the person or persons authorised to sign on behalf of the Candidate) Date:... Note: Instructions to Joint Ventures/Consortia I. Firms applying as a Joint Venture/Consortium must complete the relevant form concerning Joint Ventures/Consortia (Form 2 above). II. III. IV. The Prequalification Questionnaire must include a preliminary agreement or letter of intent stating that all partners assume joint and several liability for the execution of the contract, that the lead partner is authorised to bind, and receive instructions for and on behalf of, all partners, individually and collectively. Firms applying as a Joint Venture/Consortium must answer questions collectively, except in the case of requested documentation pertaining solely to the individual firms such as organisation charts and accounts. One partner must be appointed lead partner and that appointment confirmed by submission of powers of attorney signed by legally empowered signatories representing all the individual partners. V. The person signing this questionnaire on behalf of the Joint Venture/Consortium must have the power of attorney and guarantee the truthfulness and accuracy of all the statements made. VI. All partners in the Joint Venture/Consortium shall bind themselves to remain in the Joint Venture/Consortium from the date of submission of the Prequalification Questionnaire until the award of the Concession. Changes in the composition of the Joint Venture/Consortium may then be made only upon approval of the Client and subject to possible terms and conditions laid down in the contract. 27 P a g e

28 SECTION B TECHNICAL CAPACITY FORM CRITERION 1 FINANCIAL STANDING Addresses the following Evaluation Sub-Criteria (see Part 2 Clause 27): Sub-criterion 1a Average turnover over the past three financial years Sub-criterion 1b Average turnover over the past three financial years from services/supplies/works for the pharmaceutical and medical supplies automation sector. (i) Fill in the following table: [Year] [Year] [Year] Average Amount ( ) Amount ( ) Amount ( ) Amount ( ) 1a. Overall turnover over the past three financial years. 1b. Overall turnover over the past three financial years from services/supplies/works for the pharmaceutical and medical supplies automation sector. Exchange Rate used (if applicable, see Part 2 Clause 9): (ii) Provide a copy of the audited financial statements (including directors/partners/management report, auditor s report, cash flow statement, profit and loss account, balance sheet and the respective notes to the accounts) for the last 3 financial years. (iii) Please provide the name and address of principal banker together with banker s reference. Bank Name Address 28 P a g e

29 Town/City Postcode Banker s reference enclosed? Y/N 29 P a g e

30 CRITERION 2 GENERAL Addresses the following Evaluation Sub-Criteria (see Part 2 Clause 27): Sub-criterion 2a Equality Sub-criterion 2b Environmental management policy Sub-criterion 2c Health and Safety policy Sub-criterion 2a - Enclose your company s / companies equality policy. Sub-criterion 2b Enclose your company s / companies environmental management policy. Sub-criterion 2c Enclose your company s / companies health and safety policy. In the case of JV/Consortia with multiple policies, the Candidate shall select the three policies by which it would operate if it eventually is awarded the concession. 30 P a g e

31 CRITERION 3 CAPABILITY OF THE PROPOSED STAFF Addresses the following Evaluation Sub-Criteria (see Part 2 Clause 27): Sub-criterion 3a Qualifications in the five key areas Sub-criterion 3b Number of years in employment in the pharmaceutical/medical supplies automation sector and number of projects involved in. Sub-criterion 3a Qualifications in the five key areas For a maximum of five (5) key persons, each responsible for one of the work areas of medical/pharmaceutical, project management, engineering, information & communication technology and logistics, list the details requested below. A person may be nominated for a maximum of two work areas. A curriculum vitae must be submitted for each person nominated below. The Evaluation Committee reserves the right to verify all information given with the respective awarding bodies and may ask the Candidates to submit certificates for further verification. Name of person Title of qualification Level (MQF level or Doctoral, Masters, Degree, etc) Awarding body Year attained Medical or Pharmaceutical CV submitted? Y/N Project Management Name of person Title of qualification Level (MQF level or Doctoral, Masters, Degree, etc) Awarding body Year attained CV submitted? Y/N 31 P a g e

32 Engineering Name of person Title of qualification Level (MQF level or Doctoral, Masters, Degree, etc) Awarding body Year attained CV submitted? Y/N Information and Communication Technology Name of person Title of qualification Level (MQF level or Doctoral, Masters, Degree, etc) Awarding body Year attained CV submitted? Y/N Logistics Name of person Title of qualification Level (MQF level or Doctoral, Masters, Degree, etc) Awarding body Year attained CV submitted? Y/N 32 P a g e

33 Sub-criterion 3b Number of years in employment in the pharmaceutical/medical supplies automation sector and number of projects (Form to be replicated for each person nominated under Sub-criterion 3a) Name of person: Designation: Years in employment in the pharmaceutical/medical supplies automation sector: Projects table Project Ref. Name of Client Address Telephone Website Public or Private sector Name, description of project (max. 100 words) Role in the project Project value Date of commencement Date of completion P a g e

34 P a g e

35 Addresses the following Evaluation Sub-Criteria (see Part 2 Clause 27): CRITERION 4 PAST DELIVERIES BY THE CANDIDATE Sub-criterion 4a List of principal deliveries by the Candidate to the pharmaceutical/medical supplies automation sector over the past 5 years. Sub-criterion 4b Evidence of support provided by the Candidate. Sub-criterion 4a List of principal deliveries by the Candidate to the pharmaceuticals and medical supplies automation sector over the past 5 years. Ref. Name of Client Address Telephone Website Public or Private sector Name, description of project and staff complement involved (max. 100 words) Project value Date of commencement Date of completion Was contract satisfactorily completed in the allocated time? P a g e

36 3 4 5 At least two reference letters in support of the above are to be provided. The Evaluation Committee reserves the right to verify this information with the client. 36 P a g e

37 Question B9 Evidence of support provided by the Candidate I. Provide information about ongoing/after-sales support (e.g. on-the-spot technical support, phone support, online software updates) provided by your company. A description of support offered and a list of European clients who make/made use of such support shall be included. II. Provide reference letters from two clients (at least one located in Europe) who received such support including information with regards to efficiency of response and effectiveness of response. The evaluation committee reserves the right to verify by contacting the clients directly. For information purposes only (no points will be allocated), please also state the current addresses of the Candidate s bases of operation and staff numbers for: 1. System support 2. System development 3. Implementation. Also state the types of service contract offered including periods of cover. Describe your current model for out-of-hours support. 37 P a g e

38 SECTION C DECLARATIONS BY THE CANDIDATE FORM Statement on Conditions of Employment 1. It is hereby declared that all employees engaged on this contract shall enjoy working conditions including wages, salaries, vacation and sick leave, maternity and parental leave as provided for in the relative Employment Legislation. Furthermore, we shall comply with Chapter 424 of the Laws of Malta (Occupational Health and Safety Authority Act) as well as any other national legislation, regulations, standards and/or codes of practice or any amendment thereto in effect during the execution of the contract. 2. It is hereby declared that no part of the services to be provided under this contract shall be sub-contracted to an economic operator who has in his employment employees, who are already in employment with the bidding entity and are carrying out, with the subcontractor, the same or very similar duties as those in their contract of employment with the bidding entity. 3. The sub-contractor/s agree to all the conditions listed in this statement. 4. It is hereby declared that the service being provided under this contract will be carried out solely by the bidding entity employees, or bona fide self-employed individuals. No work will be carried out by persons designated as self-employed where their actual employment status in terms of the Employment Status National Standard Order LN 44/2012 is that of an employee. 5. It is hereby declared that all the employees of the bidding entity, whether providing services to the Client or not, have a written contract of service and are registered with the competent authority of my country, which in the case of Malta is the Employment and Training Corporation. If this tender is awarded to us, we shall furnish a list of employees who will be providing the services. Copies of the written contracts of service of the employees will be available at any time for inspection. 6. It is hereby declared that the bidding entity s employees shall be given a detailed payslip containing all relevant details including the amount paid, normal hours worked, overtime hours, hours worked on Sundays and Public Holidays, hours availed of as leave or sick leave, a breakdown of bonuses/allowances as well as deductions made (such as social security contributions and income tax). 7. It is hereby declared that all the wages/salaries of the bidding entity s employees are paid only by direct payment in the employee s bank account. 8. It is hereby declared that the relevant bank statements of wage/salaries deposit and copies of the detailed payslips will be made available as and when required by the Director of Industrial and Employment Relations. 38 P a g e

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