Medicines and Medical Devices Agency of Serbia

Contracting authority:

MEDICINES AND MEDICAL DEVICES AGENCY OF SERBIA

11221 BELGRADE – KUMODRAZ

VOJVODESTEPE STREETNO. 458

TIN: 103605344

Company registration number: 17616803

Website:

PUBLIC PROCUREMENT OF GOODS - OP - D 1/2018

PROCUREMENT OF LABORATORY SUPPLIES FORMED IN 7 SETS

OPEN PROCEDURE

January 2018

Contracting authority:

MEDICINES AND MEDICAL DEVICES AGENCY OF SERBIA

11221 BELGRADE – KUMODRAZ

VOJVODE STEPE STREET NO. 458

TIN: 103605344

Company registration number: 17616803

Website:

AnINVITATION TO BID is issued in an open public procurement procedure for a contract award in the public procurement designatedOP- DNUMBER 1/2018 – Procurement of Laboratory Supplies Formed in 7 Lots.

PROCEDURE DESIGNATION: OP - DNUMBER1/2018

The public procurement shall be carried out pursuant to Articles 32 and 61 of the Public Procurement Law(Official Gazette of RS, No. 124/12, 14/15 and 68/15, hereinafter: the Law), Article 2 of the Rulebook on mandatory elements of tender documents in public procurement procedures and manner of proving the fulfilment of the requirements(Official Gazette of RS, No. 86/15),regulations pertaining to the field of the public procurement subject, other rulebooks published by the Public Procurement Office related to the public procurement procedure (Official Gazette of RS, No. 29/13, 31/13 and 33 /13),Law of Contract and Torts(Official Gazette of the SFRY, No. 29/78, 39/85, 45/89, 57/89,Official Gazette of FRY 31/93,Official Gazette of Serbia and MontenegroNo. 1/2003 Constitutional Charter), other regulations pertaining to the field of the public procurement subject and the decision of the Agency Managing Director on initiating an open public procurement procedure, number01 – 10 dated18 January 2018 and the Decision on Forming a Committee for the Public Procurement OP - D NUMBER 1/2018 – Procurement of Laboratory Supplies Formed in 7 Lots, number 02 - 8dated18 January 2018.

Description of the public procurement procedure subject to which the tender documents refer is the procurement of laboratory supplies formed in 7 lots, specifically the following:

Designations from the general public procurement dictionary 24900000, 03300000,157000000, 03400000;

Procedure objective–the public procurement procedure is carried out for the purpose of concluding a contract on the public procurement of supplies necessary for the work of the Contracting Authority’s laboratories.

Bids are submitted in a single original copy at the address: Medicines and Medical Devices Agency of Serbia, VojvodeStepeStreet No. 458, 11221 Belgrade – Kumodraz. All bids and all accompanying documentation shall be delivered in a sealed envelope, which shall bear the following:

- the aforementioned address;

-the designationOP- DNUMBER1/2018 – Procurement of Laboratory Supplies Formed in 7 Lots, for lot number______“DO NOT OPEN”, with the designation of the contact person – PredragJovkovic.

(you must state the numbers of the lots for which you are submitting the bid).

- on the back, the name of the bidder, address and contact telephone number/fax/e-mail

The type and description of the public procurement subject is an integral part of the tender documentation.

Access to and download of tender documents:available on the Public Procurement Portal, Agency website ( via e-mail or on Agency premises, with the submission of access or download authorisation, immediately upon the announcement and issue of the invitation, by the deadline set for the submission of bids. Document download is free of charge.

Bid submission deadline: The bid submission deadline is 11 a.m. on 5March 2018 at the registry office of the Medicines and Medical Devices Agency of Serbia, Vojvode Stepe Street No. 458.Due to the amount of estimated value, the invitation for publication of the public procurement shall also be sent to the Official Gazette of the Republic of Serbia.

Bids are submitted pursuant to Article 87 of the Public Procurement Law directly or by mail.

If a bid is delivered directly or by mail, it shall be in a sealed envelope or box, sealed in such a way that during the opening of the bid it can be determined with certainty that it is being opened for the first time.

If an untimely bid has been submitted, upon completion of the opening procedure the contracting authority shall return it to the bidder unopened, with a note that it was submitted in an untimely manner.

The start and course of the deadlines are not prevented by Sundays and national holidays. If the last day of the deadline is a Sunday or a national holiday, or on any other day that is non-working for the contracting authority, the deadline shall expire on the first following day(e.g. if the last day of the bid submission deadline is a Saturday, when the contracting authority does not work, in that case the deadline shall expire on the first following working day, i.e. on Monday, unless Monday is a non-working day – e.g. a national holiday).

Public opening of bids: The bids will be opened within 30 minutes of expiration of the bid submission deadline, i.e. at 11:30 a.m. on 5March 2018, at a public opening on the premises of the Medicines and Medical Devices Agency of Serbia,VojvodeStepeStreet No. 458, in Belgrade. The procedure of opening bids will be carried out by the Agency committee in compliance with applicable regulations. The opening of the bids is public and may be attended by all interested parties. The bidders who wish to attend and take an active part in the bid opening process are obliged to submitt written authorisation for participation in the opening of bids, for the bidders’ authorised representatives, on the date of opening. A representative of the bidder taking part in the procedure of opening bids, i.e. only the bidders who have submitted authorisations have the right during the opening of the bids to examine the data from the bid which are entered in the record of opening bids. During the opening of bids a Record of the Public Opening of Bids is kept. The Record of the Opening of Bids is signed by the members of the committee and bidders’ representatives, who each receive a copy of the record. The contracting authority is obliged to deliver the record to the bidders who did not take part in the opening procedure within three days of the date of opening. The contracting authority is obliged to ensure during the procedure the safeguarding of confidential information from the bids pursuant to Article 14 of the Public Procurement Law.

Bids with significant deficiencies shall not be taken into consideration.

The general deadline for deciding on the contract award or suspension of the procedure: the Agency Managing Director shall, at the proposal of the Committee for the realisation of the public procurement, make a decision on awarding the contract or cancelling the procedure within 5 days of the date of examination and expert evaluation of the bids.

INSTRUCTIONS TO BIDDERS FOR PREPARING BIDS FOR THE OPEN PROCEDURE OF PUBLIC PROCUREMENT OF LABORATORY SUPPLIES FORMED IN 7 LOTS WITH DESIGNATIONOP - DNUMBER 1/2018

1.Description of the public procurement subject and the submission of bids: the public procurement subject is the procurement of laboratory supplies formed in 7 lots.

2.Basis for conducting the procedure:The Decision of the Managing Director of the Medicines and Medical Devices Agency of Serbia number01 – 10 dated 18 January 2018.

3.Manner of notifying bidders: By publishing an invitation to bid on the Public Procurement Portal and the Medicines and Medical Devices Agency of Serbia website ( invitation for publication of the public procurement shall also be sent to the Official Gazette of the Republic of Serbia. The contracting authority is obliged to publish the tender documents simultaneously with the invitation to bid on the Public Procurement Portal and its own website.

4.Establishing the qualifications: The right to participate in public procurement procedure is equal for all interested parties who fulfil the conditions of Article 75 and 76, and who prove the fulfilment of the conditions pursuant to Article 77 of the Public Procurement Law. The bidder shall by signing and certifying the forms in Tables 1 and 2 prove fulfilment of requirements regarding the proof of qualifications.

5.Language in the public procurement procedure: The contracting authority shall prepare tender documents and conduct the procedure in the Serbian language. For lots No. 5, 6 and 7 bids shall be submitted in the Serbian or English language. For other lots, bids shall be submitted completely or partially in the Serbian language, and in the English language in the part relating to technical characteristics, quality and technical documentation. Where the contracting authority finds, in the course of the review and evaluation of bids, that a part of a bid should be translated into the Serbian language, it shall set an adequate time limit to the bidder for translating that part of the bid into Serbian. In the event of a dispute, the Serbian version of tender documents and bid shall prevail.

6.Currency: The value in the tender documents and bid shall be expressed in RSD or EUR. The value shall be converted into dinars using the appropriate medium exchange rate of the National Bank of Serbia for one EUR valid on the date of the bid opening.

7.The content with essential elements of the bid is provided in the bid table (Table 3). The original copy of the bid should be submitted, stamped and signed by the responsible person of the bidder, referred to inT1– Information on the Bidder, with the accompanying documentation.

8.Requirements of the bid: The subject of this public procurement must be in full compliance with the technical specifications that are an integral part of the tender documents. By submitting their bids, the bidders fully and unconditionally accept the requirements set by the contracting authority in the tender documents as well as the procedure for bid submission. The bidders should carefully review and comply with all instructions, forms, provisions and specifications contained in these instructions.

9.Bid variants shall not be taken into consideration.

10.Change, revocation or cancellation of the bid: Bidders may amend or cancel their bid by written notification prior to the deadline for submission of bids. Notice of amendment or revocation should be submitted or received under the same requirements under which it was proposed, with a sign on the envelope “Amendment” or “Revocation”. Bidders shall have no right to amend or revoke their bids after the deadline for their submission.

11.The bidder may submit only one bid: The bidder who submitted a bid independently cannot participate simultaneously in a joint bid, nor can the same person participate in more joint bids. A bidder may submit a bid for one or more lots. The bid shall cover at least one entire lot. The bidder is obliged to state in the bid whether it refers to the entire procurement or only to certain lots. The bids which refer to several lots shall be submitted in such a way that each lot offered may be evaluated.

12.Receipt of bids: When receiving a bid, the contracting authority shall note down on the envelope or box containing the bid the time and date of receipt and registry number and date of the bid in order of receipt. For hand-delivered bids, the contracting authority shall issue confirmation of receipt to the bidder. It is prohibited to provide information on received bids, and the contracting authority is obliged to keep the bids in a manner that shall protect them against possession by unauthorised persons.

13.Costs of bid preparation: The bidder may include in their bid the total amount and structure of costs for bid preparation. Costs of submission and submission of the bid shall be borne exclusively by the bidder and cannot be reimbursed by the contracting authority. Where public procurement procedure was cancelled due to reasons related to the contracting authority, the contracting authority shall reimburse to the bidder the expenses for acquiring collateral, provided that the bidder requested reimbursement of these expenses in their bid. When determining evidence which proves fulfilment of requirements, the contracting authority shall pay attention to the costs of obtaining such evidence, i.e. that such costs are not disproportionate with the evaluated value of the public procurement.

14.Validity of the bid: The period of validity of the bid must be stated in the bid, but cannot be shorter than 90 days after the date set for the opening of bids. Where the bid validity period has expired, the contracting authority shall request in writing from the bidder to extend the period of bid validity. The bidder who accepts the request for extension of the bid validity period cannot change the bid.

15.Requirements to be met by the bidder in order to participate in the public procurement procedure: In order to participate in the public procurement procedure, the bidder must meet the following mandatory and additional requirements:

15.1.Mandatory requirements for participation in the public procurement procedure from Article 75 of PPL–a bidder in public procurement procedure must prove that:

15.1.1.)they are registered with the competent body, the Business Registers Agency (BRA), i.e. entered in the appropriate register;

15.1.2.)they and their legal representative have not been convicted of any criminal act as members of an organised criminal group, that they have not been convicted of criminal offences against the economy, criminal offences against the environment, criminal offences of receiving or offering bribe, criminal offence of fraud;

15.1.3.)they have paid due taxes, contributions and other public charges pursuant to the regulations of the Republic of Serbia or a foreign state, if their registered address is in its territory;

15.1.4.)when preparing their bids, the bidders shall be required to explicitly state that they fulfilled obligations under applicable legislation concerning safety at work, employment and working conditions, environmental protection, and that they have not been banned from performing economic activity by any measure in force at the time of submission of bid;

15.2.Additional requirements for participation in the public procurement procedure from Article 76 of the Law

15.2.1.)The bidder should possess sufficient financial capacity;

It shall be deemed that the bidder has sufficient financial capacity if they posted a profit in the last three financial years 2014, 2015 and 2016 and if they were not insolvent in 2017 ending with 31 December 2017;

15.2.2.)The bidder should possess sufficient business capacity;

It shall be deemed that the bidder has sufficient business capacity if they delivered the items that are the subject of public procurement in the last three financial years 2015, 2016and 2017;

15.2.3.)The bidder should possess sufficient technical capacity;

It shall be deemed that the bidder has sufficient technical capacity if they have at their disposal the adequate storage capacity (owned or rented) for storing items that are the subject of public procurement and a transport vehicle for successive delivery of items within the stipulated deadline and in good condition by the bidder to the contracting authority;

15.2.4.)The bidder should have sufficient staffing capacity;

It shall be deemed that the bidder has sufficient staffing capacity if they employ full-time or part-time at least one qualified person who will be responsible for contract execution and quality control;

15.2.5.)The bidder must prove that they are not in the bankruptcy or liquidation procedure or had been in previous bankruptcy procedure;

15.2.6.) The bidder must have the statement of conformity for all items offered with the ISO 9001 standard;

15.2.7.)The bidders shall also submit with the bid detailed specifications of items offered (catalogue number of manufacturers, technical specifications) for estimating and comparing with the requirements of technical specification;

15.2.8.)All deliveries must be in accordance with the offered quality which should comply with the requirements in the technical specifications and shall be made successively in consultation with the contracting authority;

15.2.9.)The supplier shall ensure that at the time of delivery the storage shelf life/expiry date is not less than 2/3 of the total period;

15.2.10.)For lot 1 – during the delivery, the storage and transport process must be documented in accordance with the requirements for storage conditions of said goods;

15.2.11.)To qualify for participation as a bidder of laboratory animals, the bidder must offer animals intended for laboratory examination, farmed by producers with adequate permission to carry out such activity, issued by the relevant competent body. The animals must be of appropriate type and breed and with a defined origin (as specified in the technical specification within the tender documents);

15.2.12.)For lot 6 –food for laboratory animals, process of production, packaging, storage and transport must be documented and in compliance with the veterinary and sanitary regulations, as well as FELASA recommendations;

15.2.13.)The bidder who is awarded the contract shall provide the inventory of all items in the amount of 10% of the contracted quantity within 5 days of conclusion of the contract for lots 2 and 3. On possible request of the contracting authority and after conclusion of the contract, if the bidder is unable to document the existence of inventory with the certified inventory list by the authorised person within the stipulated time, the contract shall be awarded to the first next bidder who meets the stated requirements.

15.2.14.)The bidder to whom the contract is awarded shall be required to sign an agreement on the non-disclosure of information.

15.2.15.)The bidder should define the risks (regarding delivery continuity, prices, quality etc.) which could put into question the proper execution of the contract according to the terms from the bid

16. Proof of fulfilment of mandatory requirements from Article 75 of the Public Procurement Law for legal entities as bidders:

16.1.The legal entity shall prove the fulfilment of mandatory requirements to participate in the public procurement procedure by submitting the following evidence:

16.1.1.)that it is registered with the competent authority, BRA, i.e. entered in the appropriate register, the legal entity bidder shall prove by submitting the excerpt from the register of the Business Registers Agency, i.e. court register certificate of the competent Commercial Court;