Purchaser:
MEDICINESANDMEDICALDEVICES AGENCY OF SERBIA
11221 BELGRADE – KUMODRAZ
VOJVODESTEPESTR. NO. 458
TIN(TaxIdentificationNumber)103605344
Main Identification Number: 17616803
Website:
PUBLICPROCUREMENT – PROCUREMENT OFLABORATORY MATERIALSDESIGNED IN 6SETS
OPEN PROCEDURE
PUBLIC PROCUREMENTNo. OP- D11/2015
Purchaser:
MEDICINESANDMEDICALDEVICES AGENCY OF SERBIA
11221 BELGRADE – KUMODRAZ
VOJVODESTEPESTR. NO. 458
TIN(TaxIdentificationNumber) 103605344
Main Identification Number: 17616803
Website:
Invitation forREQUEST FOR PROPOSALfor an open procedure of public procurement, for contract award in the public procurement with designation OP- DNUMBER11/2015 – Procurement of laboratory materials designed in 6 sets.
PROCEDURE INDEX:OP- DNUMBER11/2015
Public procurement will be announced pursuant to Article 32and 61 of the Law on Public Procurements(''Official Gazette of RS'', number 124/12,14/15 and 68/15), Article 2of the Rulebook on Mandatory Elements of Bidding Documentation in Public Procurements Procedures and Manner of Proving of Meeting Conditions („Off. Gazette ofRS” No. 86/2015),regulations relevant to area of subject of the public procurement, other rulebooks published by Public Procurement Officereferring 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. Gazetteof SFRJ", No. 29/78, 39/85, 57/89, "Off. Gazette ofSRJ" No. 31/93 „Off. Gazette of SCG“ No. 1/2003 Constitutional Charter),other regulation referring to area of subject of the public procurementand by decision of the Agency’s director to start public procurement open procedure, number01 – 489dated20/11/2015 and Decree on Establishing Commission for Public ProcurementOP - DNUMBER11/2015 – Procurement of laboratory materials designed in 6 sets, number 02- 1257dated20/11/2015.
Descriptionofscopeofthepublicprocurementtowhichbiddingdocumentationrefersis procurement of laboratory materials designed in 6 sets, videlicet:
Set 1 / Growth media for microbiology 1Set 2 / Growth media for microbiology 2
Set 3 / Materials for sterility and microbiological testing
Set 4 / Laboratory animals
Set 5 / Food for laboratory animals
Set6 / Bedding for laboratory animals
Denotements from procurement general dictionary are24900000,03300000,157000000, 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:
- addressstatedabove;
-designationOP- D NUMBER11/2015 – Procurement of Laboratory Materials Designed in 6 Sets, for Set number______„DONOTOPEN”andwiththecontactpersondesignation– 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 biddingdocumentation download:couldbedownloadedfromtheportalofPublicProcurementOffice, fromthe Agency’swebsite( bye-mailorintheAgency’spremises, alongwithsubmissionoftheaccessordownload authorization, immediatelyuponRequestannouncementandinvitation, andbythedeadline for proposal submission. Documentationdownloadisfreeofcharge.
-Deadlineforproposal submission:Deadline for proposal submission is18.01.2016, until 11 o’clocka.m. at the registry office of Medicines and Medical Devices AgencyofSerbia, Vojvode Stepe str.No. 458.Becauseofthe high estimated value, invitation for request for proposal will be sent toOfficial Gazette of theRepublicof Serbia as well.
-Proposal shall be submitted pursuant to the Article 87 of the LPPdirectly, 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: Proposalswillbeopenedwithin 30 minutes from deadline for proposal submission, i.e. 18.01.2016at 11:30 a.m.atpublicopeningatMedicines and Medical Devices AgencyofSerbiapremises,VojvodeStepeStr. No. 458 inBelgrade. 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.Thebidders, thatwouldliketobepresentandactively participateintheprocessofproposals’opening, areobligedtosubmitwrittenauthorizationfortheauthorizedbidders’ representativeswho would like to participate inproposals’opening, onthedayoftheproposals’opening.Bidder’srepresentative, 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:directorof the Agency, based on the proposition of the commission for realization of the public procurementwill make decision about contract award or procedure suspensionwithin 5 daysfromthedayofperformed review andexpertevaluation of proposals.
INSTRUCTIONFORBIDDERSFORCREATING OF PROPOSALFOR
OPENPROCEDUREOFTHEPUBLICPROCUREMENT OF LABORATORY MATERIALS DESIGNED IN 6 SETSWITH INDEXOP- DNUMBER 11/2015
1.Description of subject of the public procurement and proposal submission: subject of the public procurement is procurement of laboratory materials designed in 6 sets.
2.Grounds for procedure conduct:Decision of the director of Medicines and Medical Devices AgencyofSerbianumber01 – 489dated20/11/2015.
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 ( Invitation for request for proposal will be sent toOfficial 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.Eligibilityestablishment: The right to participate in public procurement procedure is equal for all interested persons who complywith conditions of Articles 75and 76, and who prove compliance with conditions pursuant to Article 77 of the Law on Public Procurements. Purchaser proves compliance with conditionsregarding eligibility by signing and verifying forms in tables1 and 2.
5.Language of the public procurement procedure: Purchaser shall prepare bidding documentation and conduct procedure in Serbian language. For sets number4,5and6, 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 dinarisor Euros.Middle exchange rate for 1 Euro of National Bank of Serbiaon the day of the beginning of proposals opening shall be used for conversion in dinars.
7.Content with the essential elements of the proposalis 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 variantswill 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 oneoremoresets. Proposalhastoinclude 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 electctronic 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 30 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 beenconvicted 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 conditionsfor participation in the public procurement procedure fromArticle 76 of the Law
16.2.1.)Bidder should possess sufficient financial capacity;
It will be considered that bidder has sufficient financial capacity, if it managed to make a profit in the last three business years 2012, 2013 and 2014, and if in 2015 he was not insolvent as of 31/11/2015;
16.2.2.)Bidder should possess sufficient business capacity;
It will be considered that bidder has sufficient business capacity, if it has been delivering items which are subject of the procurement in the last three business years 2012, 2013 and 2014;
16.2.3.)Bidder should possess sufficient technical capacity
It will be considered that bidder has sufficient technical capacity, if it possesses adequate storage capacity (owned or leased) for storage of items that are subject of public procurement and means of transport for successive delivery of items from bidder to purchaser, within the stipulated period and in proper condition;
16.2.4.)Bidder should have sufficient personnel capacityat its disposal;
It will be considered that bidder has sufficient personnel capacity if there is at least one qualified person responsible for the execution of contract and quality control, who is full-time employee or hired contractor;
16.2.5.)Bidder must demonstrate that it is not underbankruptcy or liquidation proceedings or preliminary bankruptcy proceedings;
16.2.6.)Bidder should possess declaration of compliance with ISO 9001standard for all offered items;
16.2.7.)It is mandatory for bidders to, along with the proposal, submit detailed specifications of items offered (catalog number of manufacturer, technical specifications) for evaluation and comparison with the requirements of technical specifications;
16.2.8.)All deliveries must be in compliance with the offered quality which should correspond to the requirements set out in the technical specification and shall be carried out successively per agreement with the purchaser;
16.2.9.)Supplier is under obligation to ensure that shelf life/expiry date at the time of delivery is not shorter than 2/3 of total shelf life;
16.2.10.)For sets 1 and 2, storage and transportation process must be documented during the delivery, in accordance with the requirements for the storage conditions for the said goods;
16.2.11.)To be eligible to participate as a supplier of laboratory animals, bidder must offer animals intended for laboratory testing, grown by producers with adequate permit for conduct of such activity issued by the relevant competent body. Animals must be of the proper type and strain and defined origin (as stated in the technical specification included in the bidding documentation);
16.2.12.)For set5- food for laboratory animals - the production process, packaging, storage and transportation must be documented and in compliance with veterinary and sanitary regulations, as well as with FELASA recommendations ;
16.2.13.)Bidder that is awarded the contract shall provide storage for all stock items in the amount of 30% of the agreed quantity within 5 days of the contract conclusion, except for sets number 4,5 and 6. If the bidder is unable, at a possible request by the Purchaser and after conclusion of the contract, to document the existence of storage by storage list verified by an authorized person within the prescribed period, the contract may be awarded to the first next bidder who meets the stated requirements.
16.2.14.)Bidder to whom the contract is awarded shall be required to sign a statement on protection of business secrets of the contracting authority on the statement form stipulated by Purchaser's internal procedureODR – P 15,pursuant to the Law on Medicines.
17.Proof of compliance with the mandatory requirements of Article 75 of the Law on Public Procurement for legal entities as bidders( Article 18 of the Rulebook):
17.1.A legal entity as a bidder proves compliance with the mandatory conditions for participation in the public procurement procedure, by submitting the following evidence:
17.1.1.)that is registered with the competent authority, that is, enrolled in the appropriate register, bidder - legal entity prove by submitting an extract from the register of the Business Registers Agency, or an extract from the register of the competent Commercial Court;
17.1.2.) that it and its legal representative have not been convicted for any of the offenses as members of organized crime groups, that it has not been convicted for any of the offenses against the economy, crimes against environmental protection, the offense of receiving or giving bribes, the crime of fraud - legal entities prove with:
a)Extract from criminal record or certificate issued by Basic Court in whose territory is the seat of the local legal entity, or seat of representative office or a branch of a foreign legal entity, which confirms that the legal entity has not been convicted for crimes against the economy, crimes against the environment, criminal offense of bribery, crime of fraud;
b)Excerpt from the criminal records of the Special Department for Organized Crime of the Higher Court in Belgrade, confirming that the legal entity has not been convicted of any of the criminal acts of organized crime;
c) Extract from criminal record or certificate from the competent police administration of MUP (Ministry of Internal Affairs), confirming that the bidder’s legal representative has not been convicted for any of the offenses against the economy, crimes against environmental protection, the offense of bribery, the crime of fraud and some of the criminal acts of organized crime. Note: If a bidder has more legal representatives it shall submit evidence for each of them.Entrepreneurs and natural persons prove compliance with this condition with: Excerpt from criminal records or a certificate from the competent police administration of MUP, confirming that there is no prior convictions for any offense as a member o forganized crime group, for crimes against the economy, crimes against environmental protection, the offense of bribery, the crime of fraud.
The submitted extracts from criminal records (or certificates) shall not be older than two monthsat the time of proposals opening;