Purchaser:

MEDICINES AND MEDICAL DEVICES AGENCY OF SERBIA

11221 BELGRADE – KUMODRAZ

VOJVODE STEPE STR. NO. 458

TIN (Tax Identification Number) 103605344

Main Identification Number: 17616803

Web site: www.alims.gov.rs

PUBLIC PROCUREMENT – PROCUREMENT OF LABORATORY MATERIALS DESIGNED IN 5 SETS

OPEN PROCEDURE

PUBLIC PROCUREMENT No. OP - D 1/2017

January 2017

Purchaser:

MEDICINES AND MEDICAL DEVICES AGENCY OF SERBIA

11221 BELGRADE – KUMODRAZ

VOJVODE STEPE STR. NO. 458

TIN (Tax Identification Number) 103605344

Main Identification Number: 17616803

Web site: www.alims.gov.rs

Invitation for REQUEST FOR PROPOSAL for an open procedure of public procurement, for contract award in the public procurement with designation OP - D NUMBER 1/2017 – Procurement of laboratory materials designed in 5 sets.

PROCEDURE INDEX: OP - D NUMBER 1/2017

Public procurement will be announced pursuant to Article 32 and 61 of the Law on Public Procurements (''Official Gazette of RS'', number 124/12,14/15 and 68/15), Article 2 of the Rulebook on Mandatory Elements of Bidding Documentation in Public Procurements Procedures and Manner of Proving of Meeting Conditions („Off. Gazette of RS” No. 86/2015), regulations relevant to area of subject of the public procurement, other rulebooks published by Public Procurement Office referring to public procurement procedure („Off. Gazette of RS“ No. 29 dd 29/03/2015, 31 dd 05/04/2015 and 33 dd 10/04/2015), Law on Obligatory Relations ("Off. Gazette of SFRJ", No. 29/78, 39/85, 57/89, "Off. Gazette of SRJ" No. 31/93 „Off. Gazette of SCG“ No. 1/2003 Constitutional Charter), other regulation referring to area of subject of the public procurement and by decision of the Agency’s director to start public procurement open procedure, number 01 – 554 dated 26/12/2016 and Decree on Establishing Commission for Public Procurement OP - D NUMBER 1/2017 – Procurement of laboratory materials designed in 5 sets, number 02 - 1434 dated 26/12/2016.

Description of scope of the public procurement to which bidding documentation refers is procurement of laboratory materials designed in 5 sets, videlicet:

Set 1 / Growth media for microbiology
Set 2 / Materials for sterility and microbiological testing
Set 3 / Laboratory animals
Set 4 / Food for laboratory animals
Set 5 / Bedding for laboratory animals

Denotements from procurement general dictionary are 24900000, 03300000,157000000, 03400000;

Procedure purpose – public procurement procedure shall be performed in order to conclude a contract in public procurement of prerequisite materials for operation of the Purchaser laboratories.

Proposal shall be submitted in one original version to address: Medicines and Medical Devices Agency of Serbia, Vojvode Stepe Str. No. 458. 1221 Belgrade – Kumodraz. All proposals and all accompanying documentation shall be submitted in a sealed envelope on which there should be:

- address stated above;

-designation OP - D NUMBER 1/2017 – Procurement of Laboratory Materials Designed in 5 Sets, for Set number ______„DO NOT OPEN” and with the contact person designation – Predrag Jovkovic.

(make sure to state set numbers for which proposal is submitted).

- on the back - bidder’s name, address and contact telephone/fax/E-mail

Type and description of the subject of the public procurement is a part of bidding documentation.

Access to and bidding documentation download: could be downloaded from the portal of Public Procurement Office, from the Agency’s web site (www.alims.gov.rs), by e-mail or in the Agency’s premises, along with submission of the access or download authorization, immediately upon Request announcement and invitation, and by the deadline for proposal submission. Documentation download is free of charge.

Deadline for proposal submission: Deadline for proposal submission is 14.02.2017, until 11 o’clock a.m. at the registry office of Medicines and Medical Devices Agency of Serbia, Vojvode Stepe str. No. 458. Because of the high estimated value, invitation for request for proposal will be sent to Official Gazette of the Republic of Serbia as well.

Proposal shall be submitted pursuant to the Article 87 of the LPP directly, by mail or by electronic methods of communication.

If proposal is submitted directly or by mail, it shall be in the closed envelope or box, closed in a Manner that enables to determine with certainty that it is open for the first time during opening.

Proposals received by electronic means have to be submitted in a manner stipulated by the Article 89 of the LPP, printed and logged at the registry office of the Agency by the deadline stipulated for proposal submission. If proposal is not submitted in timely manner, purchaser will return it unopened to bidder after opening procedure conclusion, with remark that it was submitted untimely.

Beginning and time-line duration shall not be prevented by Sundays and state holidays. If deadline is on Sunday or on the day of state holiday, or any other day when purchaser does not work, deadline shall be on the first next working day (e.g., if the deadline for the proposal submission is on Saturday, a non-working day for the purchaser, in such case deadline will be on the first next working day, that is Monday, providing that Monday is not non-working day as well – e.g.. state holiday).

Public opening of proposals: Proposals will be opened within 30 minutes from deadline for proposal submission, i.e. 14.02.2017 at 11:30 a.m. at public opening at Medicines and Medical Devices Agency of Serbia premises, Vojvode Stepe Str. No. 458 in Belgrade. Proposals opening procedure will be performed by Agency’s commission in accordance with current regulation. Proposal opening is a public one, and any interested party may attend it. The bidders, that would like to be present and actively participate in the process of proposals’ opening, are obliged to submit written authorization for the authorized bidders’ representatives who would like to participate in proposals’ opening, on the day of the proposals’ opening. Bidder’s representative, who participates in proposals’ opening, i.e. only bidders that have submitted authorizations, have right to access proposal’s data, which will be entered in the proposals opening minute book. During opening of the proposals, Minute book of public opening shall be kept. Minute book of proposals’ opening shall be signed by members of the commission and bidders’ representatives, who shall take possession of a one copy of the minute book. Purchaser is under obligation to deliver minute book to bidders, whch has not participated in the proposals’ opening procedure within three days form the day of opening. Purchaser is under obligation to ensure keeping of confidential data during the procedure, pursuant to the Article 14 of the Law on Public Procurements.

Proposals with major shortcomings will not be taken into consideration.

Approximate time-line for making decision about contract award or procedure suspension: director of the Agency, based on the proposition of the commission for realization of the public procurement will make decision about contract award or procedure suspension within 5 days from the day of performed review and expert evaluation of proposals.

INSTRUCTION FOR BIDDERS FOR CREATING OF PROPOSAL FOR

OPEN PROCEDURE OF THE PUBLIC PROCUREMENT OF LABORATORY MATERIALS DESIGNED IN 5 SETS WITH INDEX OP - D NUMBER 1/2017

1.  Description of subject of the public procurement and proposal submission: subject of the public procurement is procurement of laboratory materials designed in 5 sets.

2.  Grounds for procedure conduct: Decision of the director of Medicines and Medical Devices Agency of Serbia number 01 – 554 dated 26/12/2016.

3.  Manner of notifying bidders: Announcement of Request for proposal at Portal of Public Procurements and at internet web site of the Agency for medicines (www.alims.gov.rs). Invitation for request for proposal will be sent to Official Gazette of Republic of Serbia as well. Purchaser is under obligation to publicize bidding documentation at Portal of Public Procurements and at Agency’s internet web site, simultaneously with Request for proposal announcement.

4.  Eligibility establishment: The right to participate in public procurement procedure is equal for all interested persons who comply with conditions of Articles 75 and 76, and who prove compliance with conditions pursuant to Article 77 of the Law on Public Procurements. Purchaser proves compliance with conditions regarding eligibility by signing and verifying forms in tables 1 and 2.

5. Language of the public procurement procedure: Purchaser shall prepare bidding documentation and conduct procedure in Serbian language. For sets number 3, 4 and 5, proposal shall be submitted in Serbian or English language. For other sets, proposals shall be submitted in Serbian language in entirety or partly in English language in part referring to technical characteristics, quality and technical documentation. If purchaser establishes, trough review and proposal evaluation procedure, that part of a proposal should be translated to Serbian language, he will determine an appropriate time-line for bidder, which is under obligation to translate that part of proposal. In the event of a dispute, relevant version of bidding documentation, that is, proposal, is one in Serbian language.

6. Currency: Values in bidding documentation shall be stated in dinars or Euros. Middle exchange rate for 1 Euro of National Bank of Serbia on the day of the beginning of proposals opening shall be used for conversion in dinars.

7. Content with the essential elements of the proposal is provided in proposal table (Table number 3). Original of a proposal should be delivered, verified by stamp and signature of the authorized person, stated in T1– bidders’ data, with accompanying documentation.

8. Terms of proposal: Subject of this public procurement must be completely in accordance with technical specification, which is a component of bidding documentation. By submitting proposals, bidders shall accept completely and unconditionally terms which shall be established in bidding documentation by purchaser, as well as procedure of proposal submission. Bidders should carefully study and agree with all instructions, forms, stipulations and specifications included in this instruction.

9. Proposals with variants will not be taken into consideration.

10. Change, withdrawal or cancellation of proposal: bidders may change, amend or cancel their proposals in writing before deadline for proposal submission. Notification of change, amendment or cancellation should be submitted or received in the same manner as proposal is submitted, with remark on envelope "change”, “amendment” or “cancellation”. Bidders shall not have right to change, amend or cancel their proposals after proposal submission deadline..

11. Bidder may submit only one proposal: bidder that submits a proposal independently may not participate simultaneously in a joint proposal, nor the same person may participate in several joint proposals. Bidder may submit proposal for one ore more sets. Proposal has to include at least one entire set. Bidder is under obligation to state in the proposal whether proposal refers to the entire procuremet or only to certain sets. Proposals for more sets have to be submitted in such manner to make evaluation for each set possible.

12. Proposal recipience: purchaser is under obligation to mark time of a receipt on envelopes, that is, boxes, upon receipt and record proposal number and date in order of arrival. If a proposal is delivered directly, purchaser shall issue confirmation of proposal receipt. It is forbidden to provide information about received proposals until proposals openning, and purchaser is under obligation to keep proposal in a manner preventing unauthorized persons to come into possession.

13. Proposal preparation costs: bidder may submit total amount and breakdown of proposal preparation costs within the proposal. The bidder shall solely bear all costs associated with the preparation and submission of its proposal, and may not ask purchaser to reimburse such expenses. If public procurement procedure is cancelled for reasons from the purchaser side, purchaser is under obligation to reimburse expenses incured during obtaining financial securities to bidder, under provision that bidder requested reimbursement of such expenses in its proposal. Purchaser is under obligation, while determining evidence proving compliance with conditions, to take care about costs incurred while obtaining such evidence, that is, costs of evidence obtaining shall not be disproportional to estimated value of the public procurement.

14. Electronic proposal submission: electronic proposal is such proposal or part of the proposal, which bidder submits by electronic means and which comply with all requirements pursuant to the law regulating electronic signature, electronic document and electronic business. Electronic proposal must have time mark. Bidder may submit proposal in electronic form. If only a part of the proposal is submitted in electronic form, it has to make unequivocal entirety with the other parts of the same bidder’s proposal.

15. Validity period of proposal: validity period of proposal shall be stated in the proposal, but it may not be shorter than 60 days after proposal opening date. In the event of expiring of validity period, purchaser is under obligation to request extension of the period of validity from bidder, and in written. Bidder that accepts request for validity period extension shall not change its proposal.

16. Conditions that a bidder should comply with in order to participate in the public procurement procedure: In order to participate in the public procurement procedure, bidder must comply with following mandatory and additional conditions:

16.1. Mandatory conditions for participation in the public procurement procedure from Article 75 of the LPP – in the public procurement procedure, bidder has to prove:

16.1.1.) that is registered with the competent authority, or enrolled in the appropriate register;

16.1.2.) that it and its legal representative have not been convicted for any of criminal acts as a member of organized crime groups, that it has not been convicted for crimes against the economy, crimes against the environment, the offense of receiving or giving bribes, the crime of fraud;

16.1.3.) that it has settled all due taxes, contributions and other public duties in accordance with the regulations of the Republic of Serbia or a foreign country if its seat in its territory;

16.1.4.) bidders are required to expressly state in their proposals that they have been respecting the obligations arising from applicable regulations on occupational safety, employment and working conditions, environmental protection and that they were not under declaration of prohibition of conducting the activity, which is in force at the time of the proposal submission;

16.2. Additional conditions for participation in the public procurement procedure from Article 76 of the Law

16.2.1.) Bidder should possess sufficient financial capacity;