National Institute of Public Health, Trubarjeva 2, 1000 Ljubljana

Number: 4300-111/17-2/172

Date: 02.10.2017

TENDER DOSSIER

Subject of the public contract: / PURCHASE OF PNEUMOCOCCAL POLYSACCHARIDE VACCINE (ATC: J07AL01)
Public contract award procedure: / Low value contract (in accordance with Article 39, Paragraph1 of the Public Procurement Act)
Public procurement code: / 73K270917

CONTENTS OF TENDER DOSSIER

I.GENERAL

1.INVITATION TO TENDER

1.1. METHOD AND PLACE FOR DOWNLOADING THE TENDER DOSSIER

1.2. SUPPLEMENTARY CLARIFICATIONS OF THE DOSSIER

1.3. METHOD, PLACE AND DATE FOR BID RECEPTION

1.4. OPENING OF BIDS

1.5. AMENDMENTS AND WITHDRAWAL OF BIDS

1.6. LEGAL NOTE

2.INSTRUCTIONS ON COMPILING THE BID

2.1. LEGAL BASIS

2.2. LANGUAGE OF THE BID

2.3. BID VARIANTS

2.4. VALIDITY OF THE BID

2.5. SUBJECT OF THE PUBLIC CONTRACT

2.6. CONTENTS OF BID DOCUMENTS

2.7. CONDITIONS FOR THE ASSESSMENT OF CAPABILITY

2.8. METHOD FOR PROVING THE BIDDER'S CAPABILITY

2.9. CAPABILITY ASSESSMENT

2.10. BID FORMAT

2.11. JOINT BIDDING

2.12. SUBCONTRACTORS

2.13. SELECTION CRITERION

2.14. AWARD CRITERIA

2.15. CONTRACT AWARD NOTICE

2.16. CONTRACT

II.BIDDING DOCUMENTATION

1.ENVELOPE – Form 1

2.INFORMATION ON THE BIDDER – Form 2

3.INFORMATION ON THE HOLDER OF THE AUTHORISATION TO PURSUE THE ACTIVITY OF MANUFACTURING MEDICINAL PRODUCTS OR AUTHORISATION TO PURSUE THE ACTIVITY OF WHOLESALE DISTRIBUTION OF MEDICINAL PRODUCTS – Form3

4.BID – Form 4

5.SPECIFICATION – Form 5

6.BIDDER'S STATEMENT on compliance with conditions – Form 6

7.GOOD MANUFACTURING PRACTICE (GMP) STATEMENT – Form7

8.GOOD DISTRIBUTION PRACTICE (GMP) STATEMENT – Form8

9.AUTHORISATION to acquire an extract from judicial records on legal entities (legal entities with registered office in the Republic of Slovenia) – Form9.1

10.AUTHORISATION to acquire an extract from judicial records on natural persons (legal representatives, members of administrative, management and supervisory boards that are nationals of the Republic of Slovenia) – Form 9.2.

11.INFORMATION ON SUBCONTRACTORS – Form 10

12.INFORMATION ON PARTICIPATING INTERESTS IN ASSOCIATED COMPANIES – Form11

13.Model Contract – Form 12

I.GENERAL

The Contracting Authority, the National Institute of Public Health, has prepared the tender dossier in accordance with Article 67 of the Public Procurement Act (Official Gazette of the Republic of Slovenia, No.91/2006, hereinafter: ‘ ZJN-3’).

The National Institute of Public Health holds the authorisation for the wholesale marketing of medicinal products for human use. The decision was issued by the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (decision No.: 801-13/2014-2 of 19.3.2014).

Authorisation No. 801-13/2014-2 for wholesale marketing of medicinal products for human use covers the following activities:

  • purchase of medicinal products from legal entities and natural persons that hold the authorisation to pursue the activity of manufacture and wholesale distribution of medicinal products,
  • introduction of medicinal products from other European Union Member States into the Republic of Slovenia,
  • warehousing of medicinal products,
  • sale of medicinal products.

SUBJECT OF THE PUBLIC CONTRACT: / Purchase of Pneumococcal polysaccharide vaccine
TYPE OF PUBLIC CONTRACT: / Low value contract (in accordance with Article 39, Paragraph1 of the Public Procurement Act)
VALIDITY OF CONTRACT: / Until 31.08.2019
INFORMATION ABOUT THE CONTRACTING AUTHORITY: / National Institute of Public Health
Trubarjeva 2, 1000 Ljubljana
VAT Identification Number: SI 44724535
Registration Number: 6462642000
C.A. No.: IBAN SI56 0110 0600 0043 188
Person Responsible:
prim.prof.dr.(Senior MD, Prof) Ivan Eržen
Director
Contact person:
Suzana Rodela
Tel.: +386 5 6630 802
Email:
The Contracting Authority shall implement the submission procedure of public procurement under the authorisation and on behalf of other tenderees:
  • Psihiatrična bolnišnica Begunje (Begunje Psychiatric Hospital), Begunje na Gorenjskem 55, 4275 Begunje
  • Psihiatrična klinika Ljubljana (Psychiatric Hospital of Ljubljana), Studenec 48, 1260 Ljubljana
  • Zdravstveni dom Ajdovščina (Ajdovščina Community Health Centre), Tovarniška cesta 3, 5270 Ajdovščina
  • Zdravstveni dom dr. Adolfa Drolca Maribor (Dr Adolf Drolc Maribor Community Health Centre), Ulica talcev 9, 2000 Maribor
  • Zdravstveni dom Celje (Celje Community Health Centre), Gregorčičeva ulica 5, 3000 Celje
  • Zdravstveni dom Brežice (Brežice Community Health Centre), Černelčeva cesta 8, 8250 Brežice
  • Zdravstveni dom dr. Božidarja Lavriča – Cerknica (Dr Božidar Lavrič Cerknica Community Health Centre), Cesta 4. maja 17, 1380 Cerknica
  • Zdravstveni dom Domžale (Domžale Health Community Centre), Mestni trg 2, 1230 Domžale
  • Zdravstveni dom Dravograd (Dravograd Community Health Centre), Trg 4. julija 4, 2370 Dravograd
  • Zdravstveni dom dr. Franca Ambrožiča (Dr Franc Ambrožič Community Health Centre), Postojna, Prečna ulica 2, 6230 Postojna
  • Zdravstveni dom dr. Janeza Oražma (Dr Janez Oražem Community Health Centre), Ribnica, Majnikova ulica 1, 1310 Ribnica
  • Zdravstveni dom dr. Julija Polca Kamnik (Dr Julij Polec Community Health Centre), Novi trg 26, 1241 Kamnik
  • Zdravstveni dom Gornja Radgona (Gornja Radgona Community Health Centre), Partizanska cesta 40, 9250 Gornja Radgona
  • Zdravstveni dom Grosuplje (Grosuplje Community Health Centre), Pod gozdom c. I/14, 1290 Grosuplje
  • Zdravstveni dom Hrastnik (Hrastnik Community Health Centre), Novi dom 11, 1430 Hrastnik
  • Zdravstveni dom Idrija (Idrija Community Health Centre), Ulica Otona Župančiča 3, 5280 Idrija
  • Zdravstveni dom Ivančna Gorica (Ivančna Gorica Community Health Centre), Cesta II. grupe odredov 16, 1295 Ivančna Gorica,
  • Zdravstveni dom Izola (Izola Community Health Centre), Ulica oktobrske revolucije 11, 6310 Izola
  • Zdravstveni dom Koper (Koper Community Health Centre), Dellavallejeva ulica 3, 6000 Koper
  • Zdravstveni dom Krško (Krško Community Health Centre), Cesta krških žrtev 132 C, 8270 Krško
  • Zdravstveni dom Laško (Laško Community Health Centre), Kidričeva ulica5 B, 3270 Laško
  • Zdravstveni dom Lendava (Lendava Community Health Centre), Kidričeva ulica 34, 9220 Lendava
  • Zdravstveni dom Ljutomer (Ljutomer Community Health Centre), Cesta I. slovenskega tabora 2, 9240 Ljutomer
  • Zdravstveni dom Logatec (Logatec Community Health Centre), Notranjska cesta 2, 1370 Logatec
  • Zdravstveni dom Medvode (Medvode Community Health Centre), Ostrovrharjeva ulica 6, 1215 Medvode
  • Metlika Community Health Centre (Zdravstveni dom Metlika), Cesta bratstva in enotnosti 71, 8330 Metlika
  • Zdravstveni dom Murska Sobota (Murska Sobota Community Health Centre), Grajska ulica 24, 9000 Murska Sobota
  • Zdravstveni dom Osnovno varstvo Nova Gorica (Primary Care Nova Gorica Community Health Centre), Rejčeva ulica 4, 5000 Nova Gorica
  • Zdravstveni dom Novo mesto (Novo Mesto Community Health Centre), Kandijska cesta 4, 8000 Novo mesto
  • Zdravstveni dom Ormož (Ormož Community Health Centre), Ulica dr. Hrovata 4, 2270 Ormož
  • Zdravstveni dom Radeče (Radeče Community Health Centre), Ulica OF 8, 1433 Radeče
  • Zdravstveni dom Radlje ob Dravi (Radlje ob Dravi Community Health Centre), Mariborska cesta 37, 2360 Radlje ob Dravi
  • Zdravstveni dom Sevnica (Sevnica Community Health Centre), Trg svobode 14, 8290 Sevnica
  • Zdravstveni dom Sežana (Sežana Community Health Centre), Partizanska cesta 24, 6210 Sežana
  • Zdravstveni dom Slovenska Bistrica (Slovenska Bistrica Community Health Centre), Partizanska ulica 30, 2310 Slovenska Bistrica
  • Zdravstveni dom Ravne na Koroškem (Ravne na Koroškem Community Health Centre), Ob Suhi 11, 2390 Ravne na Koroškem
  • Zdravstveni dom Slovenske Konjice (Slovenske Konjice Community Health Centre), Mestni trg 17, 3210 Slovenske Konjice
  • Zdravstveni dom Tolmin (Tolmin Community Health Centre), Prešernova ulica 6a, 5220 Tolmin
  • Zdravstveni dom Trbovlje (Trbovlje Community Health Centre), Rudarska cesta 12, 1420 Trbovlje
  • Zdravstveni dom Trebnje (Trebnje Community Health Centre), Goliev trg3, 8210 Trebnje
  • Zdravstveni dom Velenje (Velenje Community Health Centre), Vodnikova cesta 1, 3320 Velenje
  • Zdravstveni dom Vrhnika (Vrhnika Community Health Centre), Cesta 6.maja 11, 1360 Vrhnika
  • Zdravstveni dom za študente Univerze v Ljubljani (University of Ljubljana Student Health Centre), Aškerčeva cesta 4, 1000 Ljubljana
  • Zdravstveni dom Zagorje (Zagorje Community Health Centre), Cesta zmage 1, 1410 Zagorje ob Savi
  • Zgornjesavinjski Zdravstveni dom Nazarje (Upper Savinja Valley Nazarje Community Health Centre), Zadrečka cesta 14, 3331 Nazarje
  • Zdravstveni dom dr. Jožeta Potrate Žalec (Dr Jože Potrata Žalec Community Health Centre), Prešernova ulica 6, 3310 Žalec
  • Splošna bolnišnica Brežice (Brežice General Hospital), Čemelčeva cesta 15, 8250 Brežice
  • Splošna bolnišnica Celje (Celje General Hospital), Oblakova ulica 5, 3000 Celje
  • Splošna bolnišnica Izola (Izola General Hospital), Polje 40, 6310 Izola
  • Splošna bolnišnica Jesenice (Jesenice General Hospital), Cesta Maršala Tita 112, 4270 Jesenice
  • Splošna bolnišnica Murska Sobota (Murska Sobota General Hospital), Rakičan, Ulica dr. Vrbnjaka 6, 9000 Murska Sobota
  • Splošna bolnišnica dr. Franca Derganca Nova Gorica (Dr Franc Derganc Nova Gorica General Hospital), Ulica padlih borcev 13 A, Šempeter pri Gorici
  • Splošna bolnišnica Novo mesto (Novo Mesto General Hospital), Šmihelska cesta 1, 8000 Novo mesto
  • Splošna bolnišnica dr. Jožeta Potrča Ptuj (Jože Potrč Ptuj General Hospital), Potrčeva cesta 23, 2250 Ptuj
  • Splošna bolnišnica Slovenj Gradec (Slovenj Gradec General Hospital), Gosposvetska cesta 1, 2380 Slovenj Gradec
  • Splošna bolnišnica Trbovlje (Trbovlje General Hospital), Rudarska cesta9, 1420 Trbovlje
  • Zavod RS za transfuzijsko medicino Ljubljana (Ljubljana Blood Transfusion Centre of Slovenia), Šlajmerjeva ulica 6, 1000 Ljubljana
  • Univerzitetni klinični center Ljubljana (Ljubljana University Medical Centre), Zaloška cesta 2, 1000 Ljubljana
The authorisation shall also include decision-making powers.
The Contract shall be concluded exclusively between the selected Bidder and the National Institute of Public Health. According to the Contract, the National Institute of Public Health shall be authorised to order goods.
BIDDER: / A bidder may be any physical or legal person eligible to have the status of a bidder according to the provisions of the Public Procurement Act (ZJN-3).
The bidder shall have a valid authorisation to pursue the activity of manufacture of medicinal products or a valid wholesale marketing authorisation for medicinal products pursuant to the legislation applying in the Republic of Slovenia.

1.INVITATION TO TENDER

Pursuant to Article67 of ZJN-3, the Contracting Authority has sent the notice on the public contract under an open procedure (hereinafter: ‘Public Contract’) for publication on the Public Procurement Portal.

Pursuant to the Public Contract, we hereby invite you to submit your bid in accordance with the instructions for compiling bids.

1.1. METHOD AND PLACE FOR DOWNLOADING THE TENDER DOSSIER

The tender documentation is available for download on the Institute's website. It is published at under the heading Public Contracts.

1.2. SUPPLEMENTARY CLARIFICATIONS OF THE DOSSIER

Candidates or bidders who may have additional questions in regard to the Tender Dossier may send these to the Contracting Authority via the Public Procurement Portal.

The final deadline for sending additional questions is 10 am on 16.10.2017.

1.3. METHOD, PLACE AND DATE FOR BID RECEPTION

We shall consider bids that arrive at the Contracting Authority's address – National Institute of Public Health, Koper Regional Unit, Vojkovo nabrežje 4a, 6000 Koper– no later than by the date and time set out as the final deadline for bid reception, in a closed or sealed envelope, which have the completed form ‘ENVELOPE’ (Form 1) affixed to the front of the envelope.

Bids must arrive at the above-mentioned address no later than by: 10 am on 24.10.2017.

Bids must be submitted in two copies, one original and one duplicate.

1.4. OPENING OF BIDS

The opening of bids shall be public and shall take place at 11 am on 24.10.2017 at the premises of the National Institute of Public Health, Koper Regional Unit, Vojkovo nabrežje 4a, 6000 Koper.

If the session for the opening of bids is attended by a person who is not the bidder's legal representative, the former shall bring with them written authorisation to participate at the public opening of bids which confirms that this person may make remarks on the record on behalf of the bidder and sign the minutes on the public opening of bids.

1.5. AMENDMENTS AND WITHDRAWAL OF BIDS

Bidders may amend or withdraw their bids by written notification which must arrive at the mailroom of the Contracting Authority prior to the expiry of the deadline for the submission of bids. If a bid is withdrawn, it shall be returned to the Bidder unopened.

The bidder's notification on the amendment or withdrawal of the bid must be prepared, enclosed, marked and delivered in the same manner as the bid, but instead of the word ‘BID’, the wording on the envelope must read ‘AMENDMENT’ or ‘WITHDRAWAL’.

1.6. LEGAL NOTE

Legal protection for bidders in the public tender procurement procedure is provided in accordance with the provisions of the Legal Protection in Public Procurement Procedures Act (Official Gazette of the Republic of Slovenia, No.43/11 and 63/11, hereinafter: ‘ZVPVPJN’, according to the procedures and manner provided by law.

A request for legal protection in public procurement procedures may be made at any stage of the procurement procedure against any action on the part of the Contracting Authority, unless the law governing the award of public contracts or the ZPVPJN stipulate otherwise. The request for legal protection may be made by an actively identified person, as defined in Article 14 of the ZPVPJN.

The request for revision must contain:

  1. name and address of applicant and the contact person,
  2. name of the Contracting Authority
  3. public procurement code,
  4. subject of the public contract,
  5. contested infringements,
  6. facts and evidence proving the infringements,
  7. power of attorney in the pre-revision and revision procedure if the applicant acts jointly with the authorised person,
  8. an indication of whether the specific public procurement procedure is co-financed from European funds, and from which fund specifically.

In accordance with the third indent of the first paragraph of Article 71 ZPVPJN, with an application of the revision request referring to the content of the notice or tender dossier, the applicant shall supplement the request with proof of payment of a charge in the amount of EUR1,000.00.

The charge shall be paid to the following subaccount open at the Bank of Slovenia for the purpose of the payment of fees for pre-revision and revision procedures, No.SI56 0110 0100 0358 802-enforcement of the budget of the Republic of Slovenia. In doing so, the applicant is required to complete the order for payment with the following information in the pre-box and the reference box: 11 16110-7111290-XXXXXXLL (the character X denotes the public procurement notice No., whereas the designation L denotes the year. if the public procurement notice number is shorter than six characters, 0 shall be written in the initial spaces.

A bidder may submit a request for a revision in the pre-revision procedure against the content of the notice or tender documentation within eight working days of the publication of the contract notice or notice of additional information, information on incomplete procedure or correction, provided this notice amends or supplements the requirements or selection criteria for the most favourable bidder, but no later than the deadline for the submission of bids.

The request for review shall be filed in duplicate in writing directly at the Contracting Authority by registered mail or registered mail with return receipt. At the same time, the applicant shall provide a copy of the application to the ministry responsible for public procurement.

2.INSTRUCTIONS ON COMPILING THE BID

2.1. LEGAL BASIS

The Tender Dossier was drawn up pursuant to the Public Procurement Act (Official Gazette of the Republic of Slovenia, No. 91/2016, hereinafter: ‘ZJN-3’), implementing regulations adopted pursuant to the Auditing of Public Procurement Procedures Act – ZRPJN (Official Gazette of the Republic of Slovenia, No. 78/1999, 90/1999 – corr., 110/2002, 2/2004 – ZPNNVSM, 42/2004, 61/2005, 78/2006, 53/2007, 32/2009 – dec. of the Const. Court), the Code of Obligations (Official Gazette of the Republic of Slovenia, No. 83/2001, 32/2004, 28/2006 – dec. of the Const. Court, 40/2007) and other regulations governing public contracts or the subject of the public contract award.

2.2. LANGUAGE OF THE BID

The bid shall be submitted entirely in the Slovenian or English languages.

2.3. BID VARIANTS

The Contracting Authority shall not consider bid variants.

2.4. VALIDITY OF THE BID

The bid shall be valid for no less than 90 days after the deadline fixed as the final deadline for the reception of bids.

2.5. SUBJECT OF THE PUBLIC CONTRACT

Purchase of Pneumococcal polysaccharide vaccine.

2.6. CONTENTS OF BID DOCUMENTS

The Contracting Authority shall consider a bid to be admissible if there are no reasons to exclude it and if the bid meets the participation conditions, the requirements and demands of the Contracting Authority stipulated in technical specifications and the Tender Dossier, is timely, without proven collusion or corruption, is not assessed as unusually low, and the bid price does not exceed the resources provided by the Contracting Authority.

For a tender to be admissible, it must contain all documents that comprise the bidding documents, including all statements, certificates or evidence required in this Tender Dossier.

The Bid shall comprise all of the forms below, which must be duly completed and signed:

  1. ENVELOPE – Form 1 – and affixed to the front of the envelope;
  2. INFORMATION ON THE BIDDER – Form 2 (in the case of joint bidding, each of the partners must complete and sign Form 2);
  3. information on the holder of the authorisation to pursue the activity of manufacturing medicinal products or authorisation to pursue the activity of the wholesale distribution of medicinal products– Form3 (in the case of joint bidding, each of the partners holding the authorisation must complete and sign Form3);
  4. good manufacturing practices (GMP) certificate;
  5. AUTHORISATION TO PURSUE THE ACTIVITY OF WHOLESALE DISTRIBUTION OF MEDICINAL PRODUCTS ISSUED BY A COMPETENT AUTHORITY REGULATING MEDICINAL PRODUCTS (if the Bidder, their partner or subcontractor is a holder of the wholesale marketing authorisation for medicinal products);
  6. bid– Form4 ( completed and signed Form4);
  7. specification– Form 5 ( completed and signed Form5);
  8. bidder's statement on the meeting of conditions– Form 6 (in the case of joint bidding, each of the partners must complete and sign Form6);
  9. statement on good manufacturing practices– Form 7 (completed and signed Form7; the form must also be signed by the person responsible for quality at the company of the holder of the authorisation to pursue the activity of manufacturing medicinal products or wholesale marketing authorisation for medicinal products);
  10. statement on good distribution practices– Form8 (filled in and signed Form8, the form shall also be signed by the person responsible for quality at the company of the holder of the authorisation to pursue the activity of manufacture of medicinal products or wholesale marketing authorisation for medicinal products);
  11. for legal persons – authorisation to acquire an EXTRACT FROM THE JUDICIAL RECORDS– Form 9.1 (in the case of joint bidding, each of the partners must complete and sign Form 9.1; applies to companies with registered offices in the Republic of Slovenia);
  12. for natural persons – authorisation to acquire an EXTRACT FROM THE JUDICIAL RECORDS– Form9.2 (for legal representatives, members of administrative, management and supervisory boards of Slovenian nationality. In the case of joint bidding, the foregoing provision applies to all partners).
  1. ESPD Form (if the Bidder bids jointly with partners or subcontractors, they must also submit the ESPD Form for partners or subcontractors)
  2. information on SUBCONTRACTORS– Form 10 (if the Bidder is bidding with subcontractors);
  3. statement on meeting conditions and consent of the subcontractor for direct payments– Form 11;
  4. CONTRACT– Model– Form 12;
  5. PARTNERSHIP CONTRACT (this applies if the Bidder participates in the bidding procedure with subcontractors).

If the country in which the Bidder is headquartered (has its registered office) does not issue such documents, the Bidder may submit a sworn statement of witnesses or a sworn statement by the Bidder instead of the written supporting document to certify the fulfilment of the condition or the ESPD form. The statement must be made before a judicial or administrative body, notary public or competent body of professional or economic institutions in the country in which the Bidder has their registered office. The ESPD form is an official statement of the economic operator that there are no reasons of exclusion and that it meets the conditions for participation, and at the same time provides the relevant information requested by the Contracting Authority. In addition, the ESPD form cites the official body or third party responsible for issuing certificates, and also includes an official statement that the economic operator will be able to present such evidence immediately on request.